Studien

ATOMIC
RANDOMIZED TRIAL OF STANDARD CHEMOTHERAPY ALONE OR COMBINED WITH ATEZOLIZUMAB AS ADJUVANT THERAPY FOR PATIENTS WITH STAGE III COLON CANCER AND DEFICIENT DNA MISMATCH REPAIR
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
EudraCT-Nummer: 2019-003562-40
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ATOMIC
Studieninformationen
Studien-Code
RUB-ID-0001
Studien-Akronym
ATOMIC
Studientitel
RANDOMIZED TRIAL OF STANDARD CHEMOTHERAPY ALONE OR COMBINED WITH ATEZOLIZUMAB AS ADJUVANT THERAPY FOR PATIENTS WITH STAGE III COLON CANCER AND DEFICIENT DNA MISMATCH REPAIR
Aktueller Studienstatus
Aktiv, rekrutierend
EudraCT-Nummer: 2019-003562-40
Beteiligte
Institute
Ruhr-Universität Bochum, Westdeutsches Tumorzentrum
Studiendesign
Studienteilnehmende Mindestalter
18 Jahr(e)
ANTONIO
Perioperative/Adjuvant atezolizumab with or without the immunomodulatory IMM-101 in patients with MSI-high or MMR-deficient stage III colorectal cancer ineligible for oxaliplatin-based chemotherapy– a randomized Phase II study
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
EudraCT-Nummer: 2020-002715-21
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ANTONIO
Studieninformationen
Studien-Code
RUB-ID-0002
Studien-Akronym
ANTONIO
Studientitel
Perioperative/Adjuvant atezolizumab with or without the immunomodulatory IMM-101 in patients with MSI-high or MMR-deficient stage III colorectal cancer ineligible for oxaliplatin-based chemotherapy– a randomized Phase II study
Aktueller Studienstatus
Aktiv, rekrutierend
EudraCT-Nummer: 2020-002715-21
Beteiligte
Institute
Ruhr-Universität Bochum, Westdeutsches Tumorzentrum
Studiendesign
Studienteilnehmende Mindestalter
18 Jahr(e)
REO 029
A phase 1 / 2 multiple-indication biomarker, safety, and efficacy study in advanced or metastatic Gastrointestinal cancers explOring treatment comBinations with peLarEorep and aTezolizumab
Arzneimittelgesetz (AMG) /
EudraCT-Nummer: 2020-003996-16
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REO 029
Studieninformationen
Studien-Code
RUB-ID-0003
Studien-Akronym
REO 029
Studientitel
A phase 1 / 2 multiple-indication biomarker, safety, and efficacy study in advanced or metastatic Gastrointestinal cancers explOring treatment comBinations with peLarEorep and aTezolizumab
EudraCT-Nummer: 2020-003996-16
Beteiligte
Institute
Ruhr-Universität Bochum, Westdeutsches Tumorzentrum
Studiendesign
Studienteilnehmende Mindestalter
18 Jahr(e)
CIRCULATE
Evaluierung der adjuvanten Therapie beim Dickdarmkrebs im Stadium II nach ctDNA-Bestimmung (CIRCULATE) AIO-KRK-0217
Arzneimittelgesetz (AMG) /
EudraCT-Nummer: 2018-003691-12
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CIRCULATE
Studieninformationen
Studien-Code
RUB-ID-0004
Studien-Akronym
CIRCULATE
Studientitel
Evaluierung der adjuvanten Therapie beim Dickdarmkrebs im Stadium II nach ctDNA-Bestimmung (CIRCULATE) AIO-KRK-0217
EudraCT-Nummer: 2018-003691-12
Beteiligte
Institute
Ruhr-Universität Bochum, Westdeutsches Tumorzentrum
Studiendesign
Studienteilnehmende Mindestalter
18 Jahr(e)
AIO-KRK/YMO-0519
Prospektive, randomisierte, offene, multizentrische Phase II Studie zur Untersuchung der Wirksamkeit von Trifluridin/Tipiracil plus Panitumumab im Vergleich zu Trifluridin/Tipiracil plus Bevacizumab bei der Erstlinientherapie des metastasierten kolorektalen Karzinoms: FIRE 8; AIO-KRK/YMO-0519
Arzneimittelgesetz (AMG) /
EudraCT-Nummer: 2019-004223-20
Zurück
AIO-KRK/YMO-0519
Studieninformationen
Studien-Code
RUB-ID-0005
Studien-Akronym
AIO-KRK/YMO-0519
Studientitel
Prospektive, randomisierte, offene, multizentrische Phase II Studie zur Untersuchung der Wirksamkeit von Trifluridin/Tipiracil plus Panitumumab im Vergleich zu Trifluridin/Tipiracil plus Bevacizumab bei der Erstlinientherapie des metastasierten kolorektalen Karzinoms: FIRE 8; AIO-KRK/YMO-0519
EudraCT-Nummer: 2019-004223-20
Beteiligte
Institute
Ruhr-Universität Bochum, Westdeutsches Tumorzentrum
Studiendesign
Studienteilnehmende Mindestalter
18 Jahr(e)
PORT / AIO-KRK-0418
Prospective, randomized, open, multicenter Phase III trial to investigate the efficacy of active post-resection/ablation therapy in patients with metastatic colorectal cancer
Arzneimittelgesetz (AMG) /
EudraCT-Nummer: 2020-006144-18
Zurück
PORT / AIO-KRK-0418
Studieninformationen
Studien-Code
RUB-ID-0006
Studien-Akronym
PORT / AIO-KRK-0418
Studientitel
Prospective, randomized, open, multicenter Phase III trial to investigate the efficacy of active post-resection/ablation therapy in patients with metastatic colorectal cancer
EudraCT-Nummer: 2020-006144-18
Beteiligte
Institute
Ruhr-Universität Bochum, Westdeutsches Tumorzentrum
Studiendesign
CNIS793E12201
daNIS-3: An open-label, multi-center, phase II platform study evaluating the efficacy and safety of NIS793 and other new investigational drug combinations with standard of care (SOC) anti-cancer therapy for the second line treatment of metastatic colorectal cancer (mCRC)
Arzneimittelgesetz (AMG) /
EudraCT-Nummer: 2021-000553-40
Zurück
CNIS793E12201
Studieninformationen
Studien-Code
RUB-ID-0007
Studien-Akronym
CNIS793E12201
Studientitel
daNIS-3: An open-label, multi-center, phase II platform study evaluating the efficacy and safety of NIS793 and other new investigational drug combinations with standard of care (SOC) anti-cancer therapy for the second line treatment of metastatic colorectal cancer (mCRC)
EudraCT-Nummer: 2021-000553-40
Beteiligte
Institute
Ruhr-Universität Bochum, Westdeutsches Tumorzentrum
Studiendesign
849-010
A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy
Arzneimittelgesetz (AMG) /
EudraCT-Nummer: 2020-004048-27
Zurück
849-010
Studieninformationen
Studien-Code
RUB-ID-0008
Studien-Akronym
849-010
Studientitel
A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy
EudraCT-Nummer: 2020-004048-27
Beteiligte
Institute
Ruhr-Universität Bochum, Westdeutsches Tumorzentrum
Studiendesign
A multi-site, open-label, Phase II, randomized, controlled trial to compare the efficacy of RO7198457 versus watchful waiting in resected, Stage II (high risk) and Stage III colorectal cancer patients who are ctDNA positive following resection
Arzneimittelgesetz (AMG) /
EudraCT-Nummer: 2020-000451-12
Zurück
Studieninformationen
Studien-Code
RUB-ID-0009
Studientitel
A multi-site, open-label, Phase II, randomized, controlled trial to compare the efficacy of RO7198457 versus watchful waiting in resected, Stage II (high risk) and Stage III colorectal cancer patients who are ctDNA positive following resection
EudraCT-Nummer: 2020-000451-12
Beteiligte
Institute
Ruhr-Universität Bochum, Westdeutsches Tumorzentrum
Studiendesign
ALL-Register
GMALL-Register und Biomaterialbank - Biomaterialsammlung und prospektive Datenerfassung zu Diagnostik, Behandlung und Krankheitsverluf der ALL des Erwachsenen
Berufsordnung (BO) / Nicht-interventionell, Multizentrisch
Zurück
ALL-Register
Studieninformationen
Studien-Code
UME-ID-4296
Studien-Akronym
ALL-Register
Studientitel
GMALL-Register und Biomaterialbank - Biomaterialsammlung und prospektive Datenerfassung zu Diagnostik, Behandlung und Krankheitsverluf der ALL des Erwachsenen
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2017,2018,2019,2020,2021,2022,2023
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Maher Hanoun

+49 (0)201 723-82530
maher.hanoun@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

GMALL-Studiengruppe

hoelzer@em.uni-frankfurt.de

Schaubstr. 16
60596 Frankfurt

Studiendesign
Registerstudie, Multizentrisch, National
Einschlusskriterien
# Alter mind. 18 Jahre
# Schriftliche Einverständniserklärung des Patienten
# Therapie analog zu einer GMALL Therapieoptimierungsstudie oder einer GMALL-Therapieempfehlung
# Eine der folgenden drei Einschlusskriterien:
# 1. akute lymphatische Leukämie
# 2. andere Leukämien (NK-Zell-Lymphom/Leukämie oder akute biphänotypische Leukämie)
# 3. Non-Hodgkin-Lymphome folgender Subtypen (WHO-Klassifikation): Burkitt-Lymphom (inkl. atypisches Burkitt-Lymphom, Burkitt-like-Lymphom), diffus großzellige B-Zell-Lymphome (insbesondere primär mediastinale DLBCL, DLBCL mit Burkitt-Signatur, c-myc-positive DLBCL), B-lymphoblastisches Lymphom, T-lymphoblastisches Lymphom, Großzellig-anaplastisches Lymphom, Sonstige NHL
Ausschlusskriterien
keine
Studienteilnehmende Mindestalter
18 Jahr(e)
Indikation
ALL - Akute lymphatische Leukämie
AML-Register
Klinisches AML-Register und Biomaterialdatenbank der Studienallianz Leukämie (SAL)
Berufsordnung (BO) / Epidemiologisch, Multizentrisch
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AML-Register
Studieninformationen
Studien-Code
UME-ID-4454
Studien-Akronym
AML-Register
Studientitel
Klinisches AML-Register und Biomaterialdatenbank der Studienallianz Leukämie (SAL)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2012,2013,2014,2015,2016,2017,2018,2019,2020,2021,2022,2023,2024
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Dr. med. Richard Noppeney

+49 (0)201 723-82530
richard.noppeney@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Klinikum der Universität München, Klinikum Großhadern

Studiendesign
Multizentrisch, National
Einschlusskriterien
AML gemäß den WHO-Diagnose-Kriterien, einschließlich Akute Promyelozyten-leukämie (APL)
Alter ≥18 Jahre
unterschriebene Einwilligungserklärung
Ausschlusskriterien
keine
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
AML - Akute myeloische Leukämie
Medizinischer Befund
AML
ProReg
Registerstudie Standard Protonentherapie WPE - Erwachsene -
Berufsordnung (BO) / Nicht-interventionell, Monozentrisch
Hintergrund der Studie ist der zunehmende klinische Einsatz der Protonentherapie. Ziel ist es, sicher zu stellen, dass bei Durchführung der Protonentherapie auswertbare Daten zu Krankheitsverlauf und Nebenwirkungen generiert werden. Mit Hilfe der in dieser Registerstudie vorgesehenen Datendokumentation soll die Grundlage für die spätere Beurteilung der Möglichkeiten und des Nutzens der Protonentherapie geschaffen werden. Die Therapiedaten aller Patienten, die eine Protonentherapie…
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ProReg
Studieninformationen
Studien-Code
UME-ID-5143
Studien-Akronym
ProReg
Studientitel
Registerstudie Standard Protonentherapie WPE - Erwachsene -
Kurzbeschreibung
Hintergrund der Studie ist der zunehmende klinische Einsatz der Protonentherapie. Ziel ist es, sicher zu stellen, dass bei Durchführung der Protonentherapie auswertbare Daten zu Krankheitsverlauf und Nebenwirkungen generiert werden. Mit Hilfe der in dieser Registerstudie vorgesehenen Datendokumentation soll die Grundlage für die spätere Beurteilung der Möglichkeiten und des Nutzens der Protonentherapie geschaffen werden. Die Therapiedaten aller Patienten, die eine Protonentherapie erhalten, werden dokumentiert.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2013,2014,2015,2016,2017,2018,2019,2020,2021,2022,2023,2024
Beteiligte
Institute
Westdeutsches Protonentherapiezentrum (WPE), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Beate Timmermann

beate.timmermann@uk-essen.de

Am Mühlenbach 1
45147 Essen

Sponsor

WPE gGmbH, Essen

Studiendesign
Registerstudie, Monozentrisch
Einschlusskriterien
• Die Indikation zur Strahlentherapie wurde gestellt.
• Protonentherapie wird als Alternative zur herkömmlichen Strahlentherapie durchgeführt. Bei
einer Protonentherapie im Rahmen der Heilkunde muss für jeden Patienten durch den
fachkundigen Arzt eine rechtfertigende Indikation gemäß § 80 StrlSchV gestellt sowie ausführlich
und belastbar dokumentiert werden. Die vorgesehene Anwendung der Protonentherapie liegt im
Bereich der Heilkunde,
- sofern sie bereits klinisch etabliert ist (z. B. gemäß Leitlinien) oder
- sofern sie hinsichtlich Indikationsstellung und Anwendungsschema (Fraktionierung,
Gesamtdosis) dem für die konventionelle Photonentherapie etablierten Heilkunde-Standard
entspricht.
• Patient nimmt an keiner klinischen Studie zur Protonentherapie teil.
• Kein Anhalt für eine Schwangerschaft. Falls erforderlich Bereitschaft zur
Schwangerschaftsverhütung während der Behandlung vorhanden.
• Patient hat in die Teilnahme an der Registerstudie und in die Datenerfassung und -verwendung
im Rahmen dieser eingewilligt.
Ausschlusskriterien
-
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Diverse
TMMR Studie
Nicht-interventionelle, prospetkive Registerstudie zur Behandlung des Cervixkarzinoms (Gebärmutterhalskrebses) der Stadien FIGO Ib bis IIa durch nervenschonende totale Mesometriale Resektion und therapeutische Lymphonodektomie nach M. Höckel
Berufsordnung (BO) / Nicht-interventionell
Beobachtungsstudie zur Behandlung des Gebärmutterhalskrebses mittels radikaler, nervenschonender Gebärmutterentfernung. Erhoben werden Überlebens- und Rückfalldaten ebenso wie Nebenwirkungen und Lebensqualitätsdaten. Aspekte der Harnblasenfunktion sowie der Sexualfunktionen werden gesondert untersucht. Ziel der Studie ist es, umfangreiche Daten zu Effektivität und Verträglichkeit dieser Form der Operation beim Gebärmutterhalskrebs zu gewinnen.
Zurück
TMMR Studie
Studieninformationen
Studien-Code
UME-ID-5190
Studien-Akronym
TMMR Studie
Studientitel
Nicht-interventionelle, prospetkive Registerstudie zur Behandlung des Cervixkarzinoms (Gebärmutterhalskrebses) der Stadien FIGO Ib bis IIa durch nervenschonende totale Mesometriale Resektion und therapeutische Lymphonodektomie nach M. Höckel
Kurzbeschreibung
Beobachtungsstudie zur Behandlung des Gebärmutterhalskrebses mittels radikaler, nervenschonender Gebärmutterentfernung. Erhoben werden Überlebens- und Rückfalldaten ebenso wie Nebenwirkungen und Lebensqualitätsdaten. Aspekte der Harnblasenfunktion sowie der Sexualfunktionen werden gesondert untersucht. Ziel der Studie ist es, umfangreiche Daten zu Effektivität und Verträglichkeit dieser Form der Operation beim Gebärmutterhalskrebs zu gewinnen.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2013,2014,2015,2016,2017,2018,2019,2020,2021,2022,2023
Beteiligte
Institute
Klinik für Frauenheilkunde und Geburtshilfe, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Paul Buderath

85239
paul.buderath@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Universitätsklinik Essen (AöR)

+49 (0)201 723-0
info@uk-essen.de

Hufelandstraße 55
45147 Essen

Studiendesign
Registerstudie
Einschlusskriterien
Adeno- oder Plattenepithelkarzinom der Cervix FIGO IB - IIA
Behandlung durch TMMR (Totale Mesometriale Resektion) + therapeutische Lymphonodektomie
Keine adjuvante Radiatio
Ausschlusskriterien
Keine Behandlung durch Totale Mesometriale Resektionund therapeutische Lymphadenektomie
Adjuvante Radiatio (außer bei R1-Situation)
Fernmetastasen (außer in paraaortalen Lymphknoten)
Sklerodermie
Lupus erythematodes
Mixed connective tissue disease
Zweitmalignom
Vorangegangene Radiatio des Beckens
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Weiblich
Indikation
Gynäkologische Tumore
Medizinischer Befund
Cervixkarzinom
ALL SCT ped FORUM
Allogene Stammzell-Transplantation bei Kindern und Jugendlichen mit Akuter Lymphoblastischer Leukämie - FORUM (For Omitting Radiotherapy Under Majority age)
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
Allogene Stammzell-Transplantation bei Kindern und Jugendlichen mit Akuter Lymphoblastischer Leukämie - FORUM (For Omitting Radiotherapy Under Majority age)
EudraCT-Nummer: 2012-003032-22
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ALL SCT ped FORUM
Studieninformationen
Studien-Code
UME-ID-5444
Studien-Akronym
ALL SCT ped FORUM
Studientitel
Allogene Stammzell-Transplantation bei Kindern und Jugendlichen mit Akuter Lymphoblastischer Leukämie - FORUM (For Omitting Radiotherapy Under Majority age)
Kurzbeschreibung
Allogene Stammzell-Transplantation bei Kindern und Jugendlichen mit Akuter Lymphoblastischer Leukämie - FORUM (For Omitting Radiotherapy Under Majority age)
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2020,2021
EudraCT-Nummer: 2012-003032-22
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Dirk Reinhardt

+49 (0)201 723-3784
dirk.reinhardt@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

St. Anna Kinderkrebsforschung, Austria

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
Patients with ALL (except for patients with mature B-ALL) who fulfil the following criteria: •age at time of diagnosis less or equal 18 years or age at time of HSCT less or equal 21 years•indication for allogeneic HSCT according to the national frontline protocols (Germany: AIEOP-BFM ALL 2009, IntReALL SR 2010, Interfant 2006, CoALL and ALL REZ BFM 2002)•complete remission (CR) before SCT •written consent of the parents (legal guardian) and, if necessary, the minor patient via “Informed Consent Form”•no pregnancy •no secondary malignancy•no previous HSCT•HSCT is performed in a study participating centre
Ausschlusskriterien
•Patients who do not fulfil the inclusion criteria•Non Hodgkin-Lymphoma•The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian•No consent is given for saving and propagation of anonymous medical data for study reasons•Severe concomitant disease that does not allow treatment according to the protocol at the investigator’s discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders; severe pulmonary, hepatic or cardial impairment due to toxicity or infection)•Karnovsky / Lansky score < 50%•Subjects unwilling or unable to comply with the study procedures* Severe renal impairment (GFR< 30% predicted for Age)* Severe liver insufficiency* Pregnancy*
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
akute lymphoblastische Leukämie
KiProReg
Registerstudie Standard Protonentherapie WPE - Kinder -
Berufsordnung (BO) / Nicht-interventionell, Monozentrisch
Hintergrund der Studie ist der zunehmende klinische Einsatz der Protonentherapie für Krebserkrankungen im Kindesalter. Ziel ist es, sicherzustellen, dass bei Durchführung der Protonentherapie auswertbare Daten zu Krankheitsverlauf und Nebenwirkungen generiert werden. Die Therapiedaten aller Kinder, die eine Protonentherapie erhalten, werden dokumentiert. Mit Hilfe dieser Datendokumentation soll die Grundlage für eine Beurteilung der Möglichkeiten und des Nutzens der Protonentherapie geschaffen werden.
Zurück
KiProReg
Studieninformationen
Studien-Code
UME-ID-5544
Studien-Akronym
KiProReg
Studientitel
Registerstudie Standard Protonentherapie WPE - Kinder -
Kurzbeschreibung
Hintergrund der Studie ist der zunehmende klinische Einsatz der Protonentherapie für Krebserkrankungen im Kindesalter. Ziel ist es, sicherzustellen, dass bei Durchführung der Protonentherapie auswertbare Daten zu Krankheitsverlauf und Nebenwirkungen generiert werden. Die Therapiedaten aller Kinder, die eine Protonentherapie erhalten, werden dokumentiert. Mit Hilfe dieser Datendokumentation soll die Grundlage für eine Beurteilung der Möglichkeiten und des Nutzens der Protonentherapie geschaffen werden.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2013,2014,2015,2016,2017,2018,2019,2020,2021,2022,2023,2024
Beteiligte
Institute
Westdeutsches Protonentherapiezentrum (WPE), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Beate Timmermann

beate.timmermann@uk-essen.de

Am Mühlenbach 1
45147 Essen

Sponsor

WPE gGmbH, Essen

Studiendesign
Registerstudie, Monozentrisch
Einschlusskriterien
- Die Indikation zur Strahlentherapie wurde gestellt.
- Protonentherapie wird als Alternative zur herkömmlichen Strahlentherapie durchgeführt. Bei einer Protonentherapie im Rahmen der Heilkunde muss für jeden Patienten durch den fachkundigen Arzt eine rechtfertigende Indikation gemäß § 80 StrlSchV gestellt sowie ausführlich und belastbar dokumentiert werden. Die vorgesehene Anwendung der Protonentherapie liegt im Bereich der Heilkunde,
- sofern sie bereits klinisch etabliert ist (z. B. gemäß Leitlinien) oder
- sofern sie hinsichtlich Indikationsstellung und Anwendungsschema (Fraktionierung, Gesamtdosis) dem für die
konventionelle Photonentherapie etablierten Heilkunde-Standard entspricht.
- Patient nimmt an keiner klinischen Studie zur Protonentherapie teil.
- Kein Anhalt für eine Schwangerschaft. Falls erforderlich Bereitschaft zur Schwangerschaftsverhütung während der Behandlung vorhanden.
- Die Eltern und der Patient haben in die Teilnahme an der Registerstudie und in die Datenerfassung und -verwendung im Rahmen dieser eingewilligt.
Ausschlusskriterien
-
Studienteilnehmende Höchstalter
17 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Diverse
APL NAPOLEON-Register
National acute promyelocytic leukemia (APL) observational study of the German AML-Intergroup
Berufsordnung (BO) / Nicht-interventionell, Multizentrisch
Zurück
APL NAPOLEON-Register
Studieninformationen
Studien-Code
UME-ID-5719
Studien-Akronym
APL NAPOLEON-Register
Studientitel
National acute promyelocytic leukemia (APL) observational study of the German AML-Intergroup
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2015,2016,2017,2018,2019,2021,2022,2023
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Dr. med. Richard Noppeney

+49 (0)201 723-82530
richard.noppeney@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Universität Leipzig

Studiendesign
Registerstudie, Multizentrisch, National
Einschlusskriterien
- newly-diagnosed APL (either de novo or therapy-related), within 12 months of diagnosis or relapsed APL, within 12 months of diagnosis of relapse
- confirmed by the presence of the translocation t(15; 17) and/or confirmed by the detection of the fusion transcript of PML/RARa
Ausschlusskriterien
none
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
APL - Promyelozytenleukämie
Sella Hypophysenstudie
Prospektive Untersuchung der Operations-bedingten Veränderungen im Nasen-Rachenraum und der Patientenzufriedenheit bei endoskopisch und mikrochirurgisch operierten Patienten mit Tumoren der Sella (Hypophysenadenome, Kraniopharyngeome, Rathe-Zysten etc.)
Berufsordnung (BO) / Nicht-interventionell
Zurück
Sella Hypophysenstudie
Studieninformationen
Studien-Code
UME-ID-5791
Studien-Akronym
Sella Hypophysenstudie
Studientitel
Prospektive Untersuchung der Operations-bedingten Veränderungen im Nasen-Rachenraum und der Patientenzufriedenheit bei endoskopisch und mikrochirurgisch operierten Patienten mit Tumoren der Sella (Hypophysenadenome, Kraniopharyngeome, Rathe-Zysten etc.)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2000,2016,2017,2018,2019,2020,2021,2022,2023,2024
Beteiligte
Institute
Klinik für Neurochirurgie und Wirbelsäulenchirurgie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Yahya Ahmadipour

yahya.ahmadipour@uk-essen.de

Hufelandstr 55
45147 Essen

Studiendesign
Registerstudie
Indikation
NONKO - Neuroonkostudien
Medizinischer Befund
Tumore der Sella \n(Hypophysenadenome, Kraniopharyngeome, Rathe-Zysten etc.)
MPN-Register
SAL-MPN-Register und Biomaterialdatenbank der Studienallianz Leukämie (SAL)
Berufsordnung (BO) / Nicht-interventionell, Multizentrisch
Zurück
MPN-Register
Studieninformationen
Studien-Code
UME-ID-5792
Studien-Akronym
MPN-Register
Studientitel
SAL-MPN-Register und Biomaterialdatenbank der Studienallianz Leukämie (SAL)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2014,2015,2016,2017,2018,2019,2020,2021
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Joachim Göthert

+49 (0)201 723-82530
joachim.goethert@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Universitätsklinikum RWTH Aachen

Studiendesign
Registerstudie, Multizentrisch
Indikation
MPN - Myeloproliferative Neoplasie
LIBRE
Lebensstilintervention bei gesunden und erkrankten BRCA 1 / 2 Mutationsträgerinnen und Frauen mit einem hohen Risiko für Brust- und Eierstockkrebs
Berufsordnung (BO) / Interventionell, Multizentrisch
Diese multizentrische prospektive randomisierte Studie evaluiert in einem ersten Schritt, ob eine Lebensstil-Intervention in der Zielgruppe überhaupt machbar ist. In einem zweiten Schritt wird dann der Einfluss der Lebensstil-Intervention auf die Inzidenz, Prognose und Mortalität der Krebserkrankung untersucht.
Zurück
LIBRE
Studieninformationen
Studien-Code
UME-ID-6285
Studien-Akronym
LIBRE
Studientitel
Lebensstilintervention bei gesunden und erkrankten BRCA 1 / 2 Mutationsträgerinnen und Frauen mit einem hohen Risiko für Brust- und Eierstockkrebs
Kurzbeschreibung
Diese multizentrische prospektive randomisierte Studie evaluiert in einem ersten Schritt, ob eine Lebensstil-Intervention in der Zielgruppe überhaupt machbar ist. In einem zweiten Schritt wird dann der Einfluss der Lebensstil-Intervention auf die Inzidenz, Prognose und Mortalität der Krebserkrankung untersucht.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2016,2021,2023,2024
Beteiligte
Institute
Klinik für Frauenheilkunde und Geburtshilfe, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Oliver Hoffmann

+49 (0)201 723-2742
oliver.hoffmann@uk-essen.de

Hufelandstr. 55
45147 Essen

Sponsor

Technische Universität München

Studiendesign
randomisiert, Multizentrisch
Einschlusskriterien
- proven pathogenic BRCA1/2 mutation
- age >=18
- written informed consent
Ausschlusskriterien
- current chemotherapy of radiotherapy (inclusion 6 weeks after CTX or RX possible)
- metastatic tumor disease
- life expectancy <3 years
- clinically limiting cardiovascular or respiratory disease (instable CVD, heart failure stage IV, COPD GOLD IV, maximum resting blood pressure 160/100 mmHg)
- significant orthopedic disability which prevents from participating in the group interventions
- severe concomitant diseases which prevents from participating in the group interventions
- Karnofsky index <60
- maximum exercise capacity <50 W
- food allergies which prevent from mediterranean diet
- vegan diet
- body mass index <15 kg/m2
- pregnancy
- insufficient knowledge of German language
- insufficient compliance
- active participation in other interventional trials
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Weiblich
Indikation
Gynäkologische Tumore
Medizinischer Befund
Brust- und Eierstockkrebs
APOLLO
A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracyclines-based chemotherapy (AIDA regimen) for patients with newly diagnosed, high-risk acute promyelocytic leukemia
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracyclines-based chemotherapy (AIDA regimen) for patients with newly diagnosed, high-risk acute promyelocytic leukemia
EudraCT-Nummer: 2015-001151-68
Zurück
APOLLO
Studieninformationen
Studien-Code
UME-ID-6788
Studien-Akronym
APOLLO
Studientitel
A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracyclines-based chemotherapy (AIDA regimen) for patients with newly diagnosed, high-risk acute promyelocytic leukemia
Kurzbeschreibung
A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracyclines-based chemotherapy (AIDA regimen) for patients with newly diagnosed, high-risk acute promyelocytic leukemia
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2017,2021
EudraCT-Nummer: 2015-001151-68
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Dr. med. Richard Noppeney

+49 (0)201 723-82530
richard.noppeney@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Technische Universität Dresden

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
- Informed consent
- women or man with a newly diagnosed APL by cytomorphology, confirmed by molecular analysis
- Age ≥18 and ≤ 65 years
- ECOG performance status 0-3
- WBC at diagnosis > 10 GPt/l
- serum total bilirubin ≤ 3.0 mg/dl (≤ 51 µmol/l)
- serum creatinine ≤ 3.0 mg/dl (≤ 260 µmol/l)
- women must fulfill at least one of the following criteria in order to be eligible for trial inclusion:
o Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH > 40 U/ml)
o Postoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy
o Continuous and correct application of a contraception method with a Pearl Index of <1% (e.g. implants, depots, oral contraceptives, intrauterine device – IUD).
o Sexual abstinence
o Vasectomy of the sexual partner
Ausschlusskriterien
- patients who are not eligible for chemotherapy as per discretion of the treating physician
- APL secondary to previous radio- or chemotherapy for non-APL disease
- other active malignancy at time of study entry (exception: Basal-Cell Carcinoma)
- lack of diagnostic confirmation of APL at genetic level
- Significant arrhythmias, ECG abnormalities
- other cardiac contraindications for intensive chemotherapy (L-VEF <50%)
- uncontrolled, life-threatening infections
- severe non controlled pulmonary or cardiac disease
- severe hepatic or renal dysfunction
- HIV and/or active hepatitis C infection
- pregnant or breast-feeding patients
- allergy to trial medication or excipients in study medication
- substance abuse; medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results
- use of other investigational drugs at the time of enrolment or within 30 days before study entry
Studienteilnehmende Mindestalter
18 Jahr(e)
Studienteilnehmende Höchstalter
65 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
APL - Promyelozytenleukämie
Medizinischer Befund
newly diagnosed high-risk acute promyelocytic leukemia (APL)
MedDRA Term
Acute promyelocytic leukaemia
SSG XXII CSTI571JIC12T
Drei oder fünf Jahre Zusatzbehandlung mit Imatinib nach Operation eines gastrointestinalen Stromatumors (GIST) bei Patienten mit hohem Rückfallrisiko: Eine randomisierte Phase III Studie der Scandinavian Sarcoma Group (SSG)
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
Weitere 2 Jahre adjuvanter Behandlung mit Imatinib könnten das rückfallsfreie Überleben von Patienten mit GIST verbessern, die trotz vorheriger 3-jähriger adjuvanter Imatinib Therapie noch ein hohes Rezidiv- Risiko haben.
EudraCT-Nummer: 2014-000898-39
Zurück
SSG XXII CSTI571JIC12T
Studieninformationen
Studien-Code
UME-ID-6944
Studien-Akronym
SSG XXII CSTI571JIC12T
Studientitel
Drei oder fünf Jahre Zusatzbehandlung mit Imatinib nach Operation eines gastrointestinalen Stromatumors (GIST) bei Patienten mit hohem Rückfallrisiko: Eine randomisierte Phase III Studie der Scandinavian Sarcoma Group (SSG)
Kurzbeschreibung
Weitere 2 Jahre adjuvanter Behandlung mit Imatinib könnten das rückfallsfreie Überleben von Patienten mit GIST verbessern, die trotz vorheriger 3-jähriger adjuvanter Imatinib Therapie noch ein hohes Rezidiv- Risiko haben.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2017,2019,2020,2021,2022
EudraCT-Nummer: 2014-000898-39
Beteiligte
Institute
Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Sebastian Bauer

sebastian.bauer@uk-essen.de

Hufelandstr. 55
45147 Essen

Sponsor

Scandinavian Sarcoma Group, Schweden

Studiendesign
randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
1. Age ≥ 18 years.
2. Morphological and immunohistological documentation of GIST (immunostaining for KIT [CD117] and/or DOG-1 positive, or mutation of KIT or PDGFRA present in tumour tissue).
3. Macroscopically complete surgical resection of GIST (either R0 or R1 resection).
4. Mutation analysis of KIT and PDGFR genes has been carried out.
5. A high risk of tumour recurrence following surgery and 3 years of adjuvant imatinib defined as one of the following:
1) gastric GIST with mitotic count >10/50 HPFs HPF, high Power field of the microscope) or >10/5mm2, or
2) non-gastric GIST with mitotic count >5/50 HPFs or >5/5 HPFs mm2, or
3) non-gastric GIST treated with neoadjuvant imatinib and initially larger than 10 cm, or
4) tumour rupture
Tumour rupture may have occurred before or at surgery. Tumour rupture is defined by spillage of the tumour contents into the abdominal cavity. A core needle biopsy from the tumour, or tumour bleed with no apparent spillage of the tumour contents, are not considered ruptures.

If only a small amount of pretreatment tumour tissue is available from a core needle biopsy, it is acceptable to multiply the mitotic count obtained from fewer than 50 HPFs to approximate the counts obtained from 50 HPFs in surgical biopsies, or to multiply the count obtained from a tumour tissue area less than 5 mm2 to approximate the counts obtained from the 5 mm2 area. However, if only minimal amount of tumour tissue is available from a core needle biopsy (from 5 or fewer HPFs, or only 1 mitosis can be identified), multiplication should not be attempted and is not considered acceptable. For further explanation of this expanded high risk classification, please see section 3.2.3.
6. ECOG performance status ≤ 2.
7. Adequate organ function, defined as serum total bilirubin <1.5 x ULN (upper limit of normal), serum AST (SGOT) and ALT (SGPT) <2.5 x ULN, creatinine <1.5 x ULN; blood ANC (neutrophil count) ≥1.0 x 109/L, platelet count ≥100 x 109/L.
8. Female patients of childbearing potential must have a negative pregnancy test within 14 days before initiation of study drug dosing. Postmenopausal women must have amenorrhoea for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
9. Patient willing to be followed up at the study site regardless of the result of randomisation.
10. Patient has provided a written, voluntary informed consent prior to study-specific screening procedures.
Ausschlusskriterien
1. Presence of distant metastases or local recurrence of GIST.
2. Not willing to donate tumour tissue and/or blood samples for the study molecular studies.
3. Presence of a substitution mutation at PDGFRA codon D842 (usually D842V).
4. Administration of adjuvant imatinib longer than for 3 years is planned regardless of the result of randomisation, or “life long” imatinib administration is planned.
5. Prior adjuvant (+ neoadjuvant) therapy with imatinib mesylate for at least 35 months has not been completed, or the total duration of prior adjuvant (+ neoadjuvant) imatinib administration exceeds the total duration of 38 months.
6. Neoadjuvant imatinib for a duration that exceeds 12 months.
7. Longer than 4-week break during adjuvant imatinib administration.
8. The dose of imatinib at completion of 3 years of adjuvant imatinib was 200 mg per day or less or greater than 800 mg per day.
9. Patient has received any investigational anti-cancer agents during adjuvant imatinib or between completion of adjuvant imatinib and the date of randomisation.
10. Patient has been free of another malignancy for less than 5 years except if the other malignancy is not currently clinically significant nor requiring active intervention, or if the other malignancy is one of the following: basal cell skin cancer, a cervical carcinoma in situ, a small (2 cm or less in diameter) node-negative breast cancer (pT1N0M0), a low Gleason score (<8) local (T1 or T2) prostate cancer. Recent existence of any other malignant disease is not allowed.
11. Patient with Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study entry).
12. Female patients who are pregnant or breast-feeding.
13. Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, severe chronic renal disease, or active uncontrolled infection).
14. Known diagnosis of human immunodeficiency virus (HIV) infection.
15. Patient with a significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Tumoren des Magen-Darm-Traktes, Mesotheliom
Medizinischer Befund
gastrointestinal stromal tumor (GIST)
CINC424C2301 / Reach 2
A phase III randomized open-label multi-center study of ruxolitinib vs. best available therapy in patients with corticosteroid-refractory acute graft vs. host disease after allogenic stem cell transplantation
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
Safety and efficacy of ruxolitinib versus best available therapy in patients with corticosteroid-refractory acute graft vs. host disease after allogeneic stem cell transplantation
EudraCT-Nummer: 2016-002584-33
Zurück
CINC424C2301 / Reach 2
Studieninformationen
Studien-Code
UME-ID-7199
Studien-Akronym
CINC424C2301 / Reach 2
Studientitel
A phase III randomized open-label multi-center study of ruxolitinib vs. best available therapy in patients with corticosteroid-refractory acute graft vs. host disease after allogenic stem cell transplantation
Kurzbeschreibung
Safety and efficacy of ruxolitinib versus best available therapy in patients with corticosteroid-refractory acute graft vs. host disease after allogeneic stem cell transplantation
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021
EudraCT-Nummer: 2016-002584-33
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Dr. med. Nina Kristin Steckel

+49 (0)201 723-3712
nina-kristin.steckel@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Novartis Pharma Schweiz AG

+41 41 763 71 11

Suurstoffi 14
6343 Rotkreuz

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
- Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or
cord blood. Recipients of non- myeloablative, myeloablative, and reduced intensity conditioning are eligible
- Clinically diagnosed Grades II to IV acute GvHD as per standard criteria occurring after alloSCT requiring systemic immune suppressive
therapy. Biopsy of involved organs with aGvHD is encouraged but not required for study screening.
- Confirmed diagnosis of corticosteroid refractory aGvHD (confirmed within 48h prior to study treatment start) defined as:
• Patients administered high-dose systemic corticosteroids (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]), given alone or combined with calcineurin inhibitors (CNI) and either:
• Progressing based on organ assessment after at least 3 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD,
OR
• Failure to achieve at a minimum partial response based on organ assessment after 7 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD,
OR
• Patients who fail corticosteroid taper defined as fulfilling either one of the following criteria:
• Requirement for an increase in the corticosteroid dose to methylprednisolone =2 mg/kg/day (or equivalent prednisone dose =2.5 mg/kg/day)
OR
• Failure to taper the methylprednisolone dose to <1 mg/kg/day (or equivalent prednisone dose <1.25 mg/kg/day) for a minimum 7 days.
Ausschlusskriterien
- Has received more than one systemic treatment for steriod refractory aGvHD,
- Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome with both acute and chronic GvHD features (as defined by Jagasia, et al. 2015)
- Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection.
Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Evidence of uncontrolled viral infection including CMV, EBV, HHV-6, HBV, or HCV based on assessment by the treating physicial.
- Presence of relapsed primary malignancy, or who have been treated for relapse after the alloHSCT was performed, or who may require rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse.
Other protocol-defined inclusion/exclusion criteria may apply.
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
corticosteroid-refractory acute graft vs. host disease after allogeneic stem cell transplantation
MedDRA Term
Acute graft versus host disease, Acute graft versus host disease in skin, Acute graft versus host disease in intestine, Acute graft versus host disease in liver
HIT-HGG-2013
Internationale Kooperative Klinische Phase-III-Studie der HIT-HGG-Studiengruppe der Gesellschaft für Pädiatrische Onkologie und Hämatologie zur Behandlung hochgradiger Gliome, diffuser intrinsischer Ponsgliome und Gliomatosis cerebri bei Kindern < 18 Jahre
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
International cooperative Phase III trial of the HIT-HGG study group for the treatment of high grade glioma, diffuse intrinsic pontine glioma, and gliomatosis cerebri in children and adolescents < 18 years.
EudraCT-Nummer: 2013-004187-56
Zurück
HIT-HGG-2013
Studieninformationen
Studien-Code
UME-ID-7236
Studien-Akronym
HIT-HGG-2013
Studientitel
Internationale Kooperative Klinische Phase-III-Studie der HIT-HGG-Studiengruppe der Gesellschaft für Pädiatrische Onkologie und Hämatologie zur Behandlung hochgradiger Gliome, diffuser intrinsischer Ponsgliome und Gliomatosis cerebri bei Kindern < 18 Jahre
Kurzbeschreibung
International cooperative Phase III trial of the HIT-HGG study group for the treatment of high grade glioma, diffuse intrinsic pontine glioma, and gliomatosis cerebri in children and adolescents < 18 years.
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2020,2021,2022,2023
EudraCT-Nummer: 2013-004187-56
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Dr. med. Regina Wieland

+49 (0)201 723-2453
regina.wieland@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Georg-August Universität Göttingen

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, National
Einschlusskriterien
• Newly diagnosed, previously untreated diffuse paediatric high grade glioma with central neuropathological review including paedHGG (WHO grade IV) and anaplastic astrocytoma (WHO grade III).
• Newly diagnosed, previously untreated diffuse intrinsic pontine glioma with central neuroradiological review
• Newly diagnosed, previously untreated gliomatosis cerebri of all tumour grades with central neuroradiological review
• Patient = 3 years and < 18 years of age at time of diagnosis
• Written informed consent of the patient and/or the patient’s parents or legal guardian according to national laws
Ausschlusskriterien
• Pre-treatment of paedHGG (WHO grade IV), anaplastic astrocytoma (WHO grade III), diffuse intrinsic pontine glioma (as confirmed by neuroradiological review), and gliomatosis cerebri (as confirmed by neuroradiological review).
• Known hypersensitivity or contraindication to study drugs and/or dacarbazine
• Prior chemotherapy within the last 30 days before HIT-HGG-2013 treatment or radiotherapy which prevents adequate performance of radiotherapy as outlined by the present protocol. This may mainly apply to patients with secondary high grade glioma after previous malignant brain tumour, e.g. medulloblastoma, ependymoma, craniopharyngeoma. If previous treatment does not prevent the adequate performance of the outlined treatment protocol patients with secondary high grade glioma will be eligible for the present trial.
• Other (simultaneous) malignancies
• Pregnancy and / or lactation
• Patients who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly)
• Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial.
• Clinical (e.g. a constitutional mismatch repair deficiency score = 3; Wimmer et al. 2014) and/or other hints (e.g. absent intratumoral immunohistochemical expression of at least one of the MLH1, MSH2, MSH6, or PMS2 mismatch repair proteins and/or high microsatellite instability) for an underlying biallelic (constitutional) mismatch repair deficiency (bMMRD/CMMRD) or a heterozygous mismatch repair deficiency (hereditary non-polyposis colon cancer syndrome/HNPCC syndrome/Lynch syndrome): These patients and their relatives should be offered human genetic counseling and rapid genetic diagnostics to confirm or rule out these conditions. These patients might not benefit from the present study treatment but maybe from other therapeutic strategies (Bouffet et al. 2016). Since patients with clinically suspected neurofibromatosis type 1 may display similar symptoms as in CMMRD, patients with clinically suspected neurofibromatosis type 1 should be also checked for CMMRD as suggested above.
• Very poor clinical condition as defined by demand of mechanical ventilation and/or demand for intravenous catecholamines and/or very severe neurological damage equivalent to a coma and/or tetraplegia with complete incapability for communication (deafness, blindness, mutism)
• Known severe concomitant diseases (e.g. immune deficiency syndrome; known tumour predisposition syndromes which do not affect adequate performance of the trial represent no exclusion criterion a priori
• Known HIV positivity
• Known severe manifest hepatic disease including hepatic porphyria as well as personal or family history of severe hepatic dysfunction, especially drug-related
• Known severe pancreatic disease
• Known lethal hepatic dysfunction in a sibling during valproic acid treatment
• Known urea cycle defect
• Known mitochondrial diseases caused by genetic mutations within the gene coding for the enzyme polymerase gamma (POLG), e.g. Alpers-Huttenlocher syndrome, as well as suspected POLG-related disorders in children under the age of two years
• Known severe coagulation disorders (in regards to thrombopenia see prerequisite for blood cell count before starting treatment)
• Valproic acid as antiepileptc drug for any pre-existing epilepsy (Exception: Valproic acid treatment due to tumour-related epilepsy will be tolerated, if the time interval between start of valproic acid treatmentand and trial enrolment is = 8 weeks.
Studienteilnehmende Mindestalter
3 Jahr(e)
Studienteilnehmende Höchstalter
17 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
First-line therapy of newly diagnosed, previously untreated high grade glioma, diffuse pontine glioma, and gliomatosis cerebri in children and adolescents <18 years.
MedDRA Term
Anaplastic astrocytoma, Malignant glioma, Brain stem glioma, Gliomatosis cerebri, Astrocytoma malignant, Ganglioglioma, Glioblastoma multiforme, Glioblastoma, Gliosarcoma
ITCC-059
A phase I/II study of Inotuzumab Ozogamicin as a single agent and in combination with chemotherapy for pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia
Clinical Trial Regulation (CTR) / Interventionell, Monozentrisch
The safety and efficacy of the medicine Inotuzumab Ozogamicin in children with relapsed/refractory acute lymphatic leukemia (ALL)
EudraCT-Nummer: 2016-000227-71
Zurück
ITCC-059
Studieninformationen
Studien-Code
UME-ID-7324
Studien-Akronym
ITCC-059
Studientitel
A phase I/II study of Inotuzumab Ozogamicin as a single agent and in combination with chemotherapy for pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia
Kurzbeschreibung
The safety and efficacy of the medicine Inotuzumab Ozogamicin in children with relapsed/refractory acute lymphatic leukemia (ALL)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021,2022,2023
EudraCT-Nummer: 2016-000227-71
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. Uta Dirksen

+49 (0)201 723-82025
uta.dirksen@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Erasmus Medical Center

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Monozentrisch, International
Einschlusskriterien
Age for all strata (Str1A, ph2, Str1B, Str2 and Str3): Patients must be ≥ 1 and < 18 years of age
Patients with Down syndrome are excluded in Stratum 1A and 1B/1BASP but not in the phase 2 cohort and Stratum 3
Additional criteria for Stratum 1A and 1B:
• First 3 patients on dose level 1 must be 6-18 yrs.
• Then at least 2 additional patients must be enrolled from age 1-6 yrs at the same dose level.
• After this: subsequent dose levels may enroll patients aged 1-18 yrs.
• In case 2 younger patients are not yet recruited, patients aged 6-18yrs may continue to be enrolled at dose level 1 until a maximum of 6 patients are enrolled.
Stratum 1A, phase 2 and stratum 1B/1B-ASP: Diagnosis
Patients must have either 1st relapsed BCP-ALL after allo-HSCT or 2nd or greater relapsed or refractory BCP-ALL, or refractory disease (after at least 2 prior regimens):
• M2 or M3 marrow status (≥ 5% blasts by morphology)
• CD22 surface antigen positive (either BM or PB)
• Stratum 1 only: The first 6 patients must have M3 marrow status (≥ 25% blasts by morphology).
Stratum 2: Diagnosis
Patients must have 2nd or greater relapsed or refractory CD22-positive B-cell malignancy including but not limited to diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), Burkitt lymphoma, Burkitt leukemia or B-cell precursor lymphoblastic lymphoma:
• Histologic verification of disease at original diagnosis or subsequent relapse
• Evaluable or measurable disease (by radiographic criteria or BM disease present)
• CD22 surface antigen positive (either biopsy material, BM or PB)
Str3: diagnosis:
• 1st BM or combined relapse of CD22+ VHR BCP-ALL defined as:
- any relapse <18 months from initial diagnosis and/or
- cytogenetic-high risk characteristics: KTM2A/AF4, E2A/TCF3-PBX1 t(1;19) or E2A/TCF3-HLF t(17;19), hypodiploidy (less than 40 chromosomes), TP53 mutation and/or deletion
• excluding patients transplanted in 1st CR.
• M2 or M3 marrow status (≥ 5% blasts by morphology)
• CD22 surface antigen positive (in either the BM or PB)
• Evidence of prior fusion gene abnormalities is acceptable
• cytogenetic-high risk characteristics determined by chromosome banding analysis (CBA), FISH, PCR and/or Next Generation Sequencing
All strata:
Performance Level and Life Expectancy:
• Karnofsky > 60% for patients > 16 years of age and Lansky > 60% for patients ≤ 16 years of age.
• life expectancy of at least 6 weeks.

Prior Therapy:
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy defined as resolution of all such non-hematologic toxicities to ≤ Grade 2 per the CTCAE 4.03.
• Chemotherapy: At least 7 days wash-out; except for hydroxyurea, 6-mp and steroids (wash-out 48 hrs) and intrathecal therapy (no wash-out). Patients who relapse while receiving maintenance chemotherapy will not be required to have a waiting period.
• Radiotherapy: At least 28 days must have elapsed since any prior radiation therapy.
• Hematopoietic Stem Cell Transplant: At least 90 days must have elapsed since previous allo-HSCT. No evidence of active GVHD; not receiving GVHD prophylaxis or treatment.
• Hematopoietic growth factors: At least 7 days wash-out of therapy with GCSF or other growth factors. At least 14 days wash-out of pegfilgrastim (Neulasta®).
• Immunotherapy: At least 42 days wash-out of any type of immunotherapy, e.g. CART therapy. No prior CD22-targeted therapy or tumor vaccines permitted.
• Monoclonal antibodies: wash-out of at least 3 half-lives of the antibody (ie: Rituximab = 66 days, Epratuzumab = 69 days), with the exclusion of blinatumomab. Patients must have been off blinatumomab infusion for at least 14 days and all drug-related toxicity must have resolved to grade 2 or lower.
• Investigational drugs: At least 7 days or 5 drug half-lives (whichever is longer) must have elapsed since prior treatment with any experimental drug (with the exception of monoclonal antibodies).
• no prior treatment with a calicheamicin-conjugated antibody (e.g. gemtuzumab ozogamicin).
Renal and Hepatic Function:
• serum creatinine ≤ 1.5 x ULN according to age. If the serum creatinine is > than 1.5 xULN, the patient must have a GFR ≥ 70mL/min/1.73m2.
• AST and ALT ≤ 2.5 x ULN.
• total bilirubin ≤ 1.5 x ULN (unless patient has documented Gilbert syndrome &AST and ALT are <=2.5 x ULN).
Cardiac Function:
• shortening fraction ≥ 30% by ECG or an ejection fraction > 50% by
MUGA.
Reproductive Function:
• If applicable, negative urine or serum pregnancy test confirmed prior to enrollment.
• If applicable, agree not to breastfeed while on this study.
• If applicable, agree using effective method of contraception during the study for 5 months (for male patients) or 8 months (for female patients) after the last dose of InO.
Ausschlusskriterien
Isolated extramedullary relapse:
• Patients with isolated extramedullary disease are excluded (not applicable to lymphoma patients except for isolated CNS-relapse)

VOD/SOS:
• Patients with any history of prior or ongoing VOD/SOS per the modified Seattle criteria are excluded, as specified in appendix 3, or prior liver-failure [defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of =1.5)].

Infection:
Patients will be excluded if they have a systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient may not have:
• A requirement for vasopressors;
• Positive blood culture within 48 hours of study enrollment;
• Fever above 38.2 within 48 hours of study enrollment with clinical signs of infection. Fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability.
• A positive fungal culture within 30 days of study enrollment.
• Active fungal, viral, bacterial, or protozoal infection requiring IV or oral treatment. Chronic prophylaxis therapy to prevent infections is allowed.

Other anti-cancer therapy:
• Patients will be excluded if there is a plan to administer non-protocol anti-cancer therapy including but not limited to chemotherapy, radiation therapy, or immunotherapy during the study period.

Allergic reaction:
• Patients with prior Grade 3/4 allergic reaction to a monoclonal antibody are excluded.

Concurrent disease:
• Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with protocol therapy, interfere with consent, study participation, follow up, or interpretation of study results.
• Patients with Down syndrome are excluded in the dose finding parts (stratum 1A and 1B), but not in the phase 2 cohort or VHR cohort.


Additional exclusion criteria for Stratum 1B
• Patients with grade 3-4 peripheral neuropathy (as defined in the Delphi consensus of acute toxic effects for childhood ALL by Schmiegelow et al.1 ). Patients with prior history of thrombosis during steroid and/or asparaginase are eligible provided they use adequate anti-coagulant prophylaxis, according to institutional guidelines.
• Patients in whom prior experience suggests that a timely delivery of therapy is unlikely or associated with an undue risk because of intolerance.

Additional exclusion criteria for Stratum 1B-ASP cohort only
• Patients with any history of PEG-asparaginase intolerance due to allergic reactions or silent inactivation during prior treatment.
• Patients with any history of prior asparaginase-associated acute pancreatitis (any grade as defined in the Delphi consensus.1).

Patients who are excluded from Stratum 1B-ASP may potentially be enrolled in Stratum 1B expansion cohort.

Additional exclusion criteria for Stratum 3 (VHR cohort) only:
• Patients who are transplanted in CR1 (such patients are eligible for the phase 1B cohort).
Studienteilnehmende Mindestalter
1 Jahr(e)
Studienteilnehmende Höchstalter
17 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
pediatric CD22-positive relapsed\/refractory Acute Lymphoblastic Leukemia
MedDRA Term
Acute lymphoblastic leukemia recurrent
ITCC-054 / AAML1621
A phase I/II study of Bosutinib in pediatric patients with Chronic Myeloid Leukemia who are resistant or intolerant to at least one prior Tyrosine Kinase Inhibitor therapy, ITCC-054/AAML1621
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
Bositinib in pediatric CML patients
EudraCT-Nummer: 2015-002916-34
Zurück
ITCC-054 / AAML1621
Studieninformationen
Studien-Code
UME-ID-7339
Studien-Akronym
ITCC-054 / AAML1621
Studientitel
A phase I/II study of Bosutinib in pediatric patients with Chronic Myeloid Leukemia who are resistant or intolerant to at least one prior Tyrosine Kinase Inhibitor therapy, ITCC-054/AAML1621
Kurzbeschreibung
Bositinib in pediatric CML patients
Aktueller Studienstatus
Geschlossen
Studie aktiv in den Jahren
2021
EudraCT-Nummer: 2015-002916-34
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Dirk Reinhardt

+49 (0)201 723-3784
dirk.reinhardt@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Erasmus Medical Center

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
1. Cytogenetic and molecular diagnosis of Philadelphia chromosome-positive CML38 at either time of initial CML diagnosis or at time of study screening:
- Cytogenetics must be performed by chromosome banding analysis (CBA) of bone marrow cell metaphases, and requires at least 20 metaphases.
- Only if dividing marrow cells cannot be obtained, or if there is an insufficient number of metaphases, CBA can be substituted by interphase fluorescence in situ hybridization (I-FISH) of bone marrow or peripheral blood cells, using dual color dual fusion probes, that allow the detection of BCR-ABL+ nuclei; at least 200 nuclei should be counted.
- Qualitative RT-PCR should be performed on RNA extracted from freshly collected bone marrow or peripheral blood cells. It identifies the transcript type, either e14a2 or 13a2 (also known as b3a2 and b2a2), or much more rarely e19a2, or e1a2, indicating the BCR-ABL protein weight (P210, rarely P230 or P190).
2. Resistance (suboptimal response or failure, as defined by 2013 European Leukemia Net guidelines24) or intolerance (with or without suboptimal response or failure) to at least one prior tyrosine kinase inhibitor (TKI).
• The 2013 European LeukemiaNet guidelines24 will be used to define suboptimal response and failure to prior TKI therapy. Details are provided in appendices 3 and 4.
-Intolerance to prior TKI therapy will be determined by the treating investigator, but generally applies to patients who are unable to receive standard or reduced doses of a TKI due to significant drug-related toxicity and/or when the drug-related toxicity is not responding to appropriate medical management. Patients who enroll as a result of intolerance to prior TKI therapy may have any level of response to their prior therapy and still be eligible.
3. Age ≥1 and <18 years at day of attaining the informed consent.
4. Lansky performance status ≥50% for patients ≤16 years of age, or Karnofsky scale ≥50% for patients >16 years of age (appendix 5).
5. Adequate bone marrow function:
-For second-line and third-line CP CML patients:
-Absolute neutrophil count >1000/mm3 (>1.0 x109/L);
-Platelets ≥75,000/mm3 (≥75 x109/L) without any platelet transfusions during the preceding 7 days.
-For fourth-line CP and all for all AP/BP CML patients:
-Absolute neutrophil count >500/mm3 (>0.5 x109/L);
-Platelets ≥50,000/mm3 (≥50 x109/L) without any platelet transfusions during the preceding 7 days.
6. Adequate Renal Function: Subjects must have a calculated creatinine clearance (CrCl) ≥ 60 mL/min/1.73 m2, using the Schwartz formula to estimate GFR (see appendix 11).
7. Adequate liver function, including:
• AST/ALT ≤2.5 x upper limit normal (ULN) or ≤5 x ULN if attributable to disease involvement of the liver;
• Total bilirubin ≤1.5 x ULN unless the patient has documented Gilbert syndrome.
8. Recovered to Grade 0-1, or to baseline, from any acute toxicities of prior chemotherapy, immunotherapy, radiotherapy, differentiation therapy, or biologic therapy, with the exception of alopecia
9. Able to reliably swallow whole capsules, whole tablets, or drug substance added to a suitable foodstuff (from capsule contents, added to either apple sauce or yoghurt); or tablets and/or capsules dissolved as an oral syringe drinking solution; or tablets dissolved and administered by NG tube when needed.
10. Serum/urine pregnancy test (for all girls ≥ age of menarche) negative at screening.
11. Male and female patients of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A patient is of childbearing potential if, in the opinion of the Investigator, he/she is biologically capable of having children and is sexually active.
12. Written informed consent of parent(s)/legal guardian(s) and/or patients (when applicable depending on age and local law and regulations)
13. Patients (including legally acceptable representative for minors where applicable) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

For phase 2 ND patients:
Criterion 2 replaced with: Newly diagnosed CP Ph+ CML of ≤ 6 months (from initial diagnosis) without any previous TKI treatment (with the exception of hydroxyurea and/or anagrelide) for CML. Diagnosis of CP CML will be defined as per Appendix 1.
Criterion 5 deleted
Ausschlusskriterien
1. Diagnosis of primary Ph+ acute lymphoblastic leukemia.
2. In patients with AP/BP CML: leptomeningeal leukemia, defined as positive cytology on lumbar puncture (including both CNS2 and CNS3 status), or clinical symptoms or signs present. This assessment is not required for inclusion of CP CML patients.
3. Extramedullary disease only.
4. Documented prior history of T315I or V299L BCR-ABL1 mutations (Note: BCR-ABL1 mutation testing will be performed at screening for a baseline assessment, but results are not used to determine eligibility. This exclusion criterion is based on whether there is a known history of these mutations at the time of study entry. If these mutations become evident during the study the patient will go off study).
5. Any prior treatment with a TKI within 7 days prior to study entry, or other anti-tumor or anti-leukemia treatment (with the exception of hydroxyurea and/or anagrelide) within 14 days prior to bosutinib treatment.
6. Prior growth factors or biologic agents within 7 days prior to bosutinib treatment.
7. Concomittant use of moderate or strong CYP3A inducers/inhibitors (see appendix 8).
8. Concomittant use of proton pump inhibitors (pH-modifying agents).
9. Prior radiotherapy within 3 months prior to bosutinib treatment.
10. Allogeneic stem cell transplantation within 3 months prior to bosutinib treatment.
11. Donor lymphocyte infusion (DLI) within 1 month prior to bosutinib treatment.
12. Hereditary bone marrow failure disorder.
13. Graft-versus-host disease (GVHD) within 60 days prior to bosutinib treatment.
14. Major surgery within 14 days prior to bosutinib treatment (recovery from any previous surgery should be complete before day 1).
15. History of clinically significant or uncontrolled cardiac disease, including:
• History of or active congestive heart failure;
• Clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
• Diagnosed or suspected congenital or acquired prolonged QT syndrome;
• History of prolonged QTc.
16. Prolonged QTc (>450 msec, average of triplicate ECGs).
17. Need for medications known to prolong the QT interval.
18. Pregnant and/or nursing women
19. Uncorrected hypomagnesemia or hypokalemia due to potential effects on the QT interval.
20. Left ventricular ejection fraction <50% or shortening fraction <28%.
21. Recent or ongoing clinically significant gastrointestinal disorder that may interfere with the intake or absorption of the drug.
22. Evidence of serious active or uncontrolled bacterial, fungal or viral infection.
23. Known history of hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness.
24. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
Chronic Myeloid Leukemia
MedDRA Term
CML
HypoPros
Intensitätsmodulierte, hypofraktionierte Radiotherapie mit Protonen im Scanning-Verfahren zur Behandlung des lokal fortgeschrittenen Prostatakarzinoms und des lokalisierten Prostatakarzinoms mit Risikofaktoren - eine Phase II Studie
Berufsordnung (BO) / Interventionell, Monozentrisch
Die Strahlentherapie ist eine etablierte Therapieoption bei der Behandlung des Prostatakarzinoms. Die intensitätsmodulierte, hypofraktionierte Strahlentherapie mit Protonen stellt eine Behandlungsmöglichkeit dar. Der grundlegende Vorgang ist dem der herkömmlichen Bestrahlung gleich. Der Unterschied liegt in Anzahl und Dosisintensität der einzelnen täglichen Bestrahlungseinheiten, der sogenannten Fraktionen. Während Patienten bei einer herkömmlichen Strahlentherapie über sieben bis acht Wochen hinweg an fünf Tagen in…
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HypoPros
Studieninformationen
Studien-Code
UME-ID-7371
Studien-Akronym
HypoPros
Studientitel
Intensitätsmodulierte, hypofraktionierte Radiotherapie mit Protonen im Scanning-Verfahren zur Behandlung des lokal fortgeschrittenen Prostatakarzinoms und des lokalisierten Prostatakarzinoms mit Risikofaktoren - eine Phase II Studie
Kurzbeschreibung
Die Strahlentherapie ist eine etablierte Therapieoption bei der Behandlung des Prostatakarzinoms. Die intensitätsmodulierte, hypofraktionierte Strahlentherapie mit Protonen stellt eine Behandlungsmöglichkeit dar. Der grundlegende Vorgang ist dem der herkömmlichen Bestrahlung gleich. Der Unterschied liegt in Anzahl und Dosisintensität der einzelnen täglichen Bestrahlungseinheiten, der sogenannten Fraktionen. Während Patienten bei einer herkömmlichen Strahlentherapie über sieben bis acht Wochen hinweg an fünf Tagen in der Woche (insgesamt ca. 35-40 Tage) mit einer Tagesdosis von 1,8 bis 2 Gy bestrahlt werden, werden Teilnehmer der HypoPros I-Studie an nur insgesamt 20 Tagen (ebenfalls an 5 Tagen in der Woche) mit einer höheren Einzeldosis (3 Gy pro Tag) behandelt. Die HypoPros I-Studie hat das Ziel, die Wirksamkeit und Verträglichkeit dieser Strahlenbehandlung zu untersuchen.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2017,2018,2019,2020,2021,2022,2023,2024
Beteiligte
Institute
Westdeutsches Protonentherapiezentrum (WPE), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Beate Timmermann

beate.timmermann@uk-essen.de

Am Mühlenbach 1
45147 Essen

Sponsor

Universitätsklinik Essen (AöR)

+49 (0)201 723-0
info@uk-essen.de

Hufelandstraße 55
45147 Essen

Studiendesign
offen, nicht-kontrolliert, Monozentrisch, National
Einschlusskriterien
- Alter ≥ 18 Jahre
- Histologisch gesichertes Prostatakarzinom (mittleres oder hohes Risikoprofil, d.h. PSA > 10 ng/ml und/oder Gleason Score ≥ 7 und/oder T-Stadium T2b-T3b)
- Körperlicher Allgemeinzustand nach WHO ≤ 2
- Bereitschaft zur Schwangerschaftsverhütung
- PSA < 50 ng/ml
- Vorliegen der unterschriebenen Einverständniserklärung
Ausschlusskriterien
- Nachweis von Fern- oder Lymphknotenmetastasen
- Indikation zur Bestrahlung des pelvinen Lymphabflusses
- Vorbestrahlung im Bereich der Prostata
- Voroperationen im Bereich der Prostata oder des Rektums
- transurethrale Resektion (TUR) vor < 3 Monaten
- vorhergehende systemische Chemotherapien
- Z. n. vorheriger Tumorerkrankung in einem anderen Organ (Ausnahme weißer Hautkrebs oder Basaliom). Patient muss bereits 3 Jahre tumorfrei sein.
- Hüftimplantate
- Herzschrittmacher
- medizinische oder psychiatrische Einschränkungen, die die Durchführung der Behandlung verhindert oder die spätere Nachsorge beeinflusst
- Diagnose einer chronisch entzündlichen Darmerkrankung (Colitis Ulcerosa oder Morbus Crohn), auch wenn derzeit kontrolliert
- Vorbestehende GI/GU-Toxizität = Grad 2, die als primärer Endpunkt definiert ist
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich
Indikation
Urogenitale Tumore
Medizinischer Befund
Prostatakarzinom
B-NHL 2013
B-NHL 2013 - Behandlungsprotokoll der NHL-BFM und der NOPHO-Studiengruppen für reife aggressive B-Zell-Lymphome und -Leukämien bei Kindern und Jugendlichen
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
no
EudraCT-Nummer: 2013-003253-21
Zurück
B-NHL 2013
Studieninformationen
Studien-Code
UME-ID-7437
Studien-Akronym
B-NHL 2013
Studientitel
B-NHL 2013 - Behandlungsprotokoll der NHL-BFM und der NOPHO-Studiengruppen für reife aggressive B-Zell-Lymphome und -Leukämien bei Kindern und Jugendlichen
Kurzbeschreibung
no
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2017,2018,2019,2020,2021,2022,2023
EudraCT-Nummer: 2013-003253-21
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Michael Schündeln

+49 (0)201 723-2500
michael.schuendeln@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Universitätsklinikum Münster

+49 (0)251 83-55555
info@ukmuenster.de

Albert-Schweitzer-Straße 33
48149 Münster

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
• newly diagnosed, histological or cytological and immunological proven aggressive mature B-cell Non-Hodgkin lymphoma including Burkitt lymphoma (BL), Burkitt leukemia (B-AL), diffuse large B-cell lymphoma (DLBCL), or mature B-cell NHL not further classified according to current WHO classification. For rare subtypes (e.g. primary mediastinal large B-NHL, PMLBL double hit lymphoma or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements), consultation of the study center is recommended.
• availability of slides/blocks for reference pathology and international pathology panel (except in cases with immunological and cytomorphological assurance of diagnosis)
• age at diagnosis < 18 years
• diagnostics and treatment in one of the participating centers of the trial
• no previous chemotherapy, no previous lymphoma-directed treatment. No application of steroids for more than two days during the last month
• adequate hepatic, renal and cardiac function, except if alteration is due to lymphoma Infiltration. Please contact the study center in case of unclear cases.
• signed informed consent of patient and or parents/guardians for treatment according to the protocol, participation and transfer of data
• follow-up of at least two years after initial diagnosis is expected
• certificate of vaccination against hepatitis B or negative serology, defined as
- evidence of immunization with HBs-antigen negative, anti-HBs positive and anti-HBc negative or
- negative hepatitis B serology with HBs-antigen negative, anti-HBs and anti-HBc negative
Ausschlusskriterien
• patients with insufficient work up not allowing a correct stratification into the risk groups
• B-cell neoplasia as second malignancy
• any other medical, psychiatric, or social condition prohibiting treatment according to the protocol (e.g. previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency, etc.)
• participation within a different trial for treatment of B-cell malignancies and/or concurrent treatment within any other clinical trial. Exceptions to this are the NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment which can run parallel to B-NHL 2013 without influencing the outcome of this trial e.g. trials on antiemetics, antibiotics, strategies for psychosocial support etc.
• overt hepatitis B or history of hepatitis B
• hypersensitivity to rituximab or to murine proteins, or to any of the other excipients of the Investigational Medicinal Product or to ingredients of other IMPs
• lack of CD20 expression of the lymphoma cells
• pregnancy and lactation
Studienteilnehmende Mindestalter
28 Woche(n)
Studienteilnehmende Höchstalter
17 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
mature aggressive B-cell lymphoma and leukemia in children and adolescents
MedDRA Term
Lymphomas non-Hodgkin's B-cell
SIOP Ependymoma II
SIOP Ependymoma II - An International Clinical Program for the diagnosis and treatment of children, adolescents and young adults with Ependymoma
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
SIOP Ependymoma II - An International Clinical Program for the diagnosis and treatment of children, adolescents and young adults with Ependymoma
EudraCT-Nummer: 2013-002766-39
Zurück
SIOP Ependymoma II
Studieninformationen
Studien-Code
UME-ID-7487
Studien-Akronym
SIOP Ependymoma II
Studientitel
SIOP Ependymoma II - An International Clinical Program for the diagnosis and treatment of children, adolescents and young adults with Ependymoma
Kurzbeschreibung
SIOP Ependymoma II - An International Clinical Program for the diagnosis and treatment of children, adolescents and young adults with Ependymoma
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022,2023
EudraCT-Nummer: 2013-002766-39
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Gudrun Fleischhack

+49 (0)201 / 723 84667
gudrun.fleischhack@uk-essen.de

Hufelandstr. 55
45147 Essen

Sponsor

Centre Leon Berard, France

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
Overall program
•Main residence in one of the participating countries
•Age < 22 years old at the diagnosis
•Newly diagnosed intracranial or spinal ependymoma (all WHO grades) including ependymoma variants: cellular, papillary myxopapillary, clearcell and tanicytic) or anaplastic ependymoma
•Delivery of FFPE tumour tissue blocks (or charged slides with sufficient interpretable material and curls in an Eppendorf tube) to national referral pathology center
•Written informed consent for data and study biological samples collection
•All patients and/or their parents or legal guardians willing and able to comply with protocol schedule and agree to sign a written informed consent
•Patients must be affiliated to a Social Security System in countries where this is mandatory

After Initial surgery, patients will be enrolled in one of 3 different interventional strata where they will be offered a set of therapeutic interventions based on the outcome of the intervention (no measurable residue vs residual inoperable disease), their age and/or their eligibility /suitability to receive radiotherapy.

Patients with centrally and histologically confirmed intracranial ependymoma (histology confirmed by National Reference centre for Biology and Pathology review) meeting the following criteria will be enrolled into one of interventional strata:

•Main residence in one of the participating countries,
•Age below 22 years old at the diagnosis,
•Newly diagnosed with an ependymoma WHO grade II and III, including ependymoma variants: cellular, papillary, clear-cell and tanycytic or anaplastic ependymoma.
•Post-menarchal female not pregnant or nursing (breast feeding) and with a negative beta-HCG pregnancy test prior to commencing the trial,
•Males and females of reproductive age and childbearing potential with effective contraception (see section 4.1.2.4 Definition of highly effective methods of contraception) for the duration of their treatment and 6 month after the completion of their treatment,
•Patients and/or their parents or legal guardians willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedure

Specific inclusion criteria have been defined for each stratum of the program.

Stratum 1:
•Age = 12 months and < 22 years at time of study entry
•No residual measurable ependymoma based on the central neuroradiological review (detailed in protocol)
•Histologically confirmed WHO Grade II-III ependymoma by central pathological review
•No metastasis on spinal MRI and on CSF cytology assessments
•No previous radiotherapy
•No previous chemotherapy
•No co-existent unrelated disease (e.g. renal, hematological) at the time of study entry that would render the Patient unable to receive chemotherapy
•No medical contraindication to radiotherapy and chemotherapy,
•No signs of infection
•Adequate bone marrow function(detailed in protocol)
•Adequate liver function (detailed in protocol)
•Adequate renal function (detailed in protocol)

Stratum 2:
•Age = 1 year and <22 years at time of entry to study
•Residual non reoperable measurable ependymoma based on central neuro-radiological review (detailed in protocol)
•Histologically confirmed WHO Grade II-III ependymoma by central pathological review
•No metastasis on spinal MRI and on CSF cytology assessments
•No previous radiotherapy
•No previous chemotherapy
•No co-existent unrelated disease (e.g. renal, hematological) at the time of study entry that would render the Patient unable to receive chemotherapy
•No medical contraindication to radiotherapy and chemotherapy,
•No signs of infection
Adequate bone marrow function( detailed in protocol)
•Adequate liver function (detailed in protocol)
•Adequate renal function (detailed in protocol)


Stratum 3
•Children younger than 12 months at time of entry to study or any children ineligible to receive radiotherapy due to age at diagnosis, tumour location or clinician/parent decision and according to national criteria
•Histologically confirmed WHO Grade II-III ependymoma by central pathological review
•Adequate bone marrow function(detailed in protocol)
•Adequate liver function (detailed in protocol)
•Adequate renal function (detailed in protocol)
•No previous chemotherapy
•No previous radiotherapy
•No co-existent unrelated disease (e.g. renal, hematological) at the time of study entry that would render the Patient unable to receive chemotherapy
•No contraindication to chemotherapy

Patients that do not fulfill the inclusion criteria of one of the interventional strata will be enrolled and followed up into an observational study and descriptive analysis will be performed
Ausschlusskriterien
All interventional stata
•Tumour entity other than primary intracranial ependymoma
•Primary diagnosis predating the opening of SIOP Ependymoma II
•Patients with WHO grade I ependymoma including ependymoma variants: myxopapillary ependymomas and subependymomas
•Patients with spinal cord location of the primary tumour
•Participation within a different trial for treatment of ependymoma
•Age = 22 years
•Contraindication to one of the IMP used in this stratum according to the SmPCs in appendix 4 of the study protocol (SmPCs in appendices are those from UK which were chosen for the assessment of the safety as aspects of the study)
•Concurrent treatment with any anti-tumour agents
•Inability to tolerate chemotherapy
•Unable to tolerate intravenous hydration
•Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results in the judgment of the Investigator
•Pre-existing mucositis, peptic ulcer, inflammatory bowel disease, ascites, or pleural effusion
•Pregnancy and breast feeding

Stratum 1 and 2:
•Ineligible to receive radiotherapy
•Patient for whom imaging remains RX despite all effort to clarify the MRI conclusion
•Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results in the judgment of the investigator

Stratum 3:
•Pre-existing severe hepatic (liver) and/or renal (kidney) damage
Family history of severe epilepsy
•Presence of previously undiagnosed mitochondrial disorder detected by screening as part of trial
•Elevated blood ammonium level = 1.5 x upper limit of the normal
•Elevated Blood lactate level = 1.5 x upper limit of the normal
•Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results in the judgment of the investigator
Studienteilnehmende Mindestalter
28 Tag(e)
Studienteilnehmende Höchstalter
64 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
Newly diagnosed with an intracranial or spinal ependymoma (all WHO grades) including ependymoma variants: cellular, papillary, myxopapillary, clear-cell and tanycytic) or anaplastic ependymoma.
MedDRA Term
Ependymoma
PEMBROLIZUMAB MK3475 NIERENZELL
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
EudraCT-Nummer: 2016-004351-75
Zurück
PEMBROLIZUMAB MK3475 NIERENZELL
Studieninformationen
Studien-Code
UME-ID-7504
Studien-Akronym
PEMBROLIZUMAB MK3475 NIERENZELL
Studientitel
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2019,2021
EudraCT-Nummer: 2016-004351-75
Beteiligte
Institute
Klinik für Urologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med Christian Niedworok

christian.niedworok@uk-essen.de

Hufelandstr. 55
45147 Düsseldorf

Sponsor

MSD Merck Sharp & Dohme LLC

Studiendesign
Multizentrisch
Einschlusskriterien
1. Must have histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features. Diagnosis of RCC with clear cell component is to be made by the investigator and does not require central histology review.
2. Be ≥ 18 years of age on day of signing informed consent.
3. Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
4. Female participants of childbearing potential must be willing to use an adequate method of contraception as outlined in the protocol, for the course of the trial through 120 days after the last dose of trial drug must be collected within 10 days prior to randomization.
5. Male participants of childbearing potential must be willing to use an adequate method of contraception as outlined in the protocol, for the course of the trial through 120 days after the last dose of trial drug.
6. The participant provides written informed consent/assent for the trial. The participant may also provide consent/assent for Future Biomedical Research; however the participant may participate in the main trial without participating in Future Biomedical Research.
7. Have intermediate-high risk, high risk, or M1 NED RCC as defined by the following pathological tumor-node-metastasis and Fuhrman grading status:
a) Intermediate-high risk RCC
-pT2, Gr. 4 or sarcomatoid, N0, M0
-pT3, Any Gr., N0, M0
b) High risk RCC
- pT4, Any Gr. N0, M0
-pT Any stage, Any Gr., N+, M0
c) M1 NED RCC -participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following:
- the time of nephrectomy (synchronous) or,
- ≤1 year from nephrectomy (metachronous)
8. Have received no prior systemic therapy for advanced RCC
9. Have undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants) with negative surgical margins.
10. Must have undergone a nephrectomy and/or metastasectomy ≥28 days prior to signing informed consent and ≤12 weeks prior to randomization.
11. Must be tumor-free as assessed by the Investigator and validated by either CT or MRI scan of the brain and CAP and a bone scan ≤28 days from randomization. All baseline scans must be sent to the central imaging vendor and receipt must be confirmed prior to randomization .
12. Must have provided adequate tissue per the following:
- Nephrectomy only: tissue from nephrectomy (required).
- Synchronous M1 NED: tissue from nephrectomy (required) AND, metastasectomy issue (if available).
- Metachronous M1 NED: tissue from metastasectomy (required) AND, nephrectomy tissue (if available).
Adequacy of the samples for biomarker analysis will be evaluated by a central laboratory.
13. Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
14. Have adequate organ function as defined in the protocol. Specimens.
Ausschlusskriterien
1. Has had major surgery, other than nephrectomy and/or resection of pre-existing metastases for M1 NED participants, within 12 weeks prior to randomization.
2. Has received prior radiotherapy for RCC.
3. Has pre-existing brain or bone metastatic lesions.
4. Has residual thrombus post nephrectomy in the vena renalis or vena cava
5. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within days prior the first dose of study treatment.
6. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic
treatment and is allowed.
7. Has a known additional malignancy that is progressing or required active treatment =3 years ago. Exceptions include early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer, or in situ breast cancer that has
undergone potentially curative therapy.
8. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
9. Has an active infection requiring systemic therapy
10. Has a history of, or is currently on, dialysis
11. Has a known history of human immunodeficiency virus infection. No human immunodeficiency virus testing is required unless mandated by local health authority.
12. Has a known active hepatitis B (hepatitis B surface antigen reactive) or hepatitis C virus (eg, hepatitis C virus [HCV] RNA [qualitative] is detected)
13. Has a known history of active tuberculosis (Bacillus tuberculosis).
14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
15. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial in the opinion of the investigator 16.Has had a prior solid organ transplant.
17. Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
18. A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours before randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Participants must be excluded/discontinued from the trial in the event of a positive or borderline positive test result.
19 .Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the Screening visit through 120 days after the last dose of study treatment.
20. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2 agent or with an agent directed to another co-inhibitory T-cell receptor (ie, CTLA-4, OX-40, CD137) or has previously participated in a Merck pembrolizumab (MK 3475) clinical trial.
21. Has received prior anticancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) before first dose of study treatment or not recovered (ie, must be =Grade 1 or at baseline) from AEs due to previously administered agents.
22. Has received a live vaccine within 30 days prior to the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine.
Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed
23. Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Urogenitale Tumore
Medizinischer Befund
Treatment of participants with RCC in the adjuvant setting
MedDRA Term
Renal carcinoma
SUNNIFORECAST
A Phase 2, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Standard of Care in Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
A Phase 2, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Standard of Care in Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma
EudraCT-Nummer: 2016-000706-12
Zurück
SUNNIFORECAST
Studieninformationen
Studien-Code
UME-ID-7506
Studien-Akronym
SUNNIFORECAST
Studientitel
A Phase 2, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Standard of Care in Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma
Kurzbeschreibung
A Phase 2, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Standard of Care in Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2018,2019,2020,2021
EudraCT-Nummer: 2016-000706-12
Beteiligte
Institute
Klinik für Urologie, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Viktor Grünwald

+49 (0)201 723-3213
urologie.studien@uk-essen.de

Hufelandstr. 55
45147 Essen

Sponsor

Goethe-Universität, Frankfurt

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
1. Signed Written Informed Consenta) Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.b) Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
2. Target Population
a) Histological confirmation of non-clear RCC with at least 50% non-clear cell component according to actual WHO classification36
b) Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
c) Karnofsky > 70% (See Appendix 2, 14.2)
d) Measurable disease as per RECIST v 1.1 (See Appendix 3, 14.3) documented by an English radiology report
e) Tumor tissue (FFPE archival or recent acquisition) must be available and sent to the central pathological reviewer (see Table 6) in order to confirm the diagnosis. (Note: Fine Needle Aspiration [FNA] and bone metastases samples are not acceptable for submission).
f) Patients with all risk categories will be eligible for the study. Patients will be stratified for papillary or non-papillary non-clear cell histology and IMDC risk score Patients will be categorized according to favorable versus intermediate versus poor risk status at registration according to the International Metastatic RCC Database Consortium (IMDC) criteria:
i. KPS equal to 70%
ii. Less than 1 year from diagnosis to randomization
iii. Hemoglobin less than the lower limit of normal (LLN)
iv. Corrected calcium concentration greater than the upper limit of normal (ULN)
v. Absolute neutrophil count greater than the ULN
vi. Platelet count greater than the ULNIf none of the above factors are present, subjects are only eligible for the favorable-risk cohort, if1-2 factors are present subjects are catogerized as intermediate risk and > 3 factors as poor risk.
3. Age and Reproductive Status
a) Males and Females, = 18 years of age
b) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
c) Women must not be breastfeeding
d) WOCBP must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo five half-lives. The terminal half-lives of Nivolumab and Ipilimumab are up to 25 days and 18 days, respectively. The terminal half-life of the active metabolite of Sunitinib is up to 110 hours. The terminal half-life of other standard of care agents has to be derived from the product information.
i. WOCBP randomized to receive Nivolumab + Ipilimumab should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for Nivolumab to undergo five half-lives) after the last dose of investigational drug.
ii. WOCBP randomized to receive a standard of care agent should use an adequate method to avoid pregnancy for at least 8 weeks (30 days plus the time required for the active metabolite of the standard of care agent to undergo five half-lives)
e) Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo five half-lives. The terminal half-lives of Nivolumab and Ipilimumab are up to 25 days and 18 days, respectively. The terminal half-life of the active metabolite of Sunitinib is up to 110 hours.
i. Males randomized to receive Nivolumab combined with Ipilimumab who are sexually active with WOCBP must continue contraception for 31 weeks (90 days plus the time required for Nivolumab to undergo five half-lives) after the last dose of investigational drug.
ii. Males randomized to receive standard of care who are sexually active with WOCBP must continue contraception for at least 16 weeks (90 days plus the time required for the active metabolite of the standard of care agent to undergo five half-lives) after the last dose of investigational drug.
f) Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However they must still undergo pregnancytesting as described in this section.
Ausschlusskriterien
1) Any active brain metastases requiring systemic corticosteroids.
2) Tumors with a clear-cell component of > 50% Medical History and Concurrent Diseases
3) Prior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but not limited to, Sunitinib, pazopanib, axitinib, tivozanib, and bevacizumab) or prior treatment with an mTOR inhibitor or cytokines.
4) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
5) Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormonereplacement are permitted to enroll.
6) Any condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
7) Uncontrolled adrenal insufficiency.
8) Ongoing symptomatic cardiac dysrhythmias, uncontrolled atrial fibrillation, or prolongation of the Fridericia corrected QT (QTcF) interval defined as > 450 msec for males and > 470 msec for females, where QTcF = QT / 3vRR
9) Poorly controlled hypertension (defined as systolic blood pressure (SBP) of = 150 mmHg or diastolic blood pressure (DBP) of = 90 mmHg), despite antihypertensive therapy.
10) History of any of the following cardiovascular conditions within 12 months of enrollment:cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association.
11) History of cerebrovascular accident including transient ischemic attack within the past 12 months.
12) History of deep vein thrombosis (DVT) unless adequately treated with low molecular weight heparin
13) History of pulmonary embolism within the past 6 months unless stable, asymptomatic, and treated with low molecular weight heparin for at least 6 weeks.
14) History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months.
15) Serious, non-healing wound or ulcer.
16) Evidence of active bleeding or bleeding susceptibility; or medically significant hemorrhage within prior 30 days.
17) Any requirement for anti-coagulation, except for low molecular weight heparin.
18) Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
19) Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
20) Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
21) Known medical condition (eg, a condition associated with diarrhea or acute diverticulitis) that, in the investigator’s opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.
22) Major surgery (eg, nephrectomy) less than 28 days prior to the first dose of study drug.
23) Anti-cancer therapy less than 28 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.
24) Receiving concomitant CYP3A4 inducers or strong CYP3A4 inhibitors
25) Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of Sunitinib
26) Left ventricular ejection fraction (LVEF) less than the LLN as assessed by echocardiography or multigated acquisition (MUGA) scan.
27) Any of the following laboratory test findings:
i. WBC < 2,000/mm3
ii. Neutrophils < 1,500/mm3
iii. Platelets < 100,000/mm3
iv. AST or ALT > 3 x ULN (> 5 x ULN if liver metastases are present)
v. Total Bilirubin > 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
vi. Serum creatinine > 1.5 x upper limit of normal (ULN) or creatinine clearance < 40 mL/min (measured or calculated by Cockroft-Gault formula):
28) History of severe hypersensitivity reaction to any monoclonal antibody.
29) Subjects who are incompetent to understand and sign the informed consent.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Urogenitale Tumore
Medizinischer Befund
Non-clear cell RCC
MedDRA Term
Renal cell carcinoma stage unspecified
INITIAL-1
An open label phase II study to evaluate the efficacy and safety of Inotuzumab Ozogamicin for Induction Therapy followed by a conventional chemotherapy based consolidation and maintenance therapy In patients aged 56 years and older with Acute Lymphoblastic leukemia (ALL).
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
An open label phase II study to evaluate the efficacy and safety of Inotuzumab Ozogamicin for Induction Therapy followed by a conventional chemotherapy based consolidation and maintenance therapy In patients aged 56 years and older with Acute Lymphoblastic leukemia (ALL).
EudraCT-Nummer: 2016-004836-39
Zurück
INITIAL-1
Studieninformationen
Studien-Code
UME-ID-7548
Studien-Akronym
INITIAL-1
Studientitel
An open label phase II study to evaluate the efficacy and safety of Inotuzumab Ozogamicin for Induction Therapy followed by a conventional chemotherapy based consolidation and maintenance therapy In patients aged 56 years and older with Acute Lymphoblastic leukemia (ALL).
Kurzbeschreibung
An open label phase II study to evaluate the efficacy and safety of Inotuzumab Ozogamicin for Induction Therapy followed by a conventional chemotherapy based consolidation and maintenance therapy In patients aged 56 years and older with Acute Lymphoblastic leukemia (ALL).
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2018,2020,2021
EudraCT-Nummer: 2016-004836-39
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Maher Hanoun

+49 (0)201 723-82530
maher.hanoun@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Goethe-Universität, Frankfurt

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, National
Einschlusskriterien
1. Male or female patients, >56 years of age and fit for therapy
2. Newly diagnosed acute lymphoblastic leukemia (>25% marrow blasts, assessed by morphology; i.e., M2 or M3 marrow)
3. Leukemic blasts must have CD22 surface expression of a least 20%, assessed by local/institutional flow cytometry of a bone marrow aspirate sample (assessment of CD22 via the reference lab for immungenetics is strongly recommended). In the case of an inadequate aspirate sample (dry tap), flow cytometry of peripheral blood specimen may be substituted if the patient has circulating blasts; alternatively, CD22 expression may be documented by immunohistochemistry of a bone marrow biopsy specimen
4. No previous ALL-specific treatment with the exception of corticosteroids and/or single dose vincristine and/or a maximum of three doses of cyclophosphamide (cumulative dose of 600mg/m2) and the standard prephase treatment
5. With or without documented CNS involvement
6. Adequate liver function, including total serum bilirubin <2.0 x ULN unless the patient has documented Gilbert syndrome, and aspartate and alanine aminotransferase (AST and ALT) <2.5 x ULNIf organ function abnormalities are considered due to leukemic infiltration of the liver, total serum bilirubin must be < 2.5 x ULN and AST/ALT <5 x ULN
7. Serum creatinine 40 mL/min
8. WHO performance status <2
9. Signed written inform consent 10. Inclusion in GMALL registry
Ausschlusskriterien
1. Philadelphia-chromosome or BCR-ABL positive ALL
2. Burkitt’s or mixed phenotype acute leukemia based on the WHO 2008 criteria
3. Peripheral absolute lymphoblast count >10,000/µL after pre-phase treatment and before start of study medication
4. Known systemic vasculitis (e.g., Wegener’s granulomatosis, polyarteritis nodosa, systemic lupus erythematosus), primary or secondary immunodeficiency (such as HIV infection or severe inflammatory disease)
5. Current or chronic hepatitis B or C infection as evidenced by hepatitis B surface antigen and anti-hepatitis C antibody positivity, respectively, or known seropositivity for human immunodeficiency virus (HIV)
6. Major surgery within <4 weeks before entry on study
7. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function or unstable pulmonary condition)
8. Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer that has been definitely treated with radiation or surgery; patients with previous malignancies are eligible provided that they have been disease free for >2 years
9. Cardiac function, as measured by left ventricular ejection fraction (LVEF) that is less than 45%, or the presence of New York Heart Association (NYHA) stage III or IV congestive heart failure
10. Myocardial infarction <6 months before entry on study
11. History of clinically significant ventricular arrhythmia, or unexplained syncope not believed to be vasovagal in nature, or chronic bradycardic states such as sinoatrial block or higher degrees of AV block unless a permanent pacemaker has been implanted
12. Uncontrolled electrolyte disorders that can confound the effects of a QTc prolonging drug (e.g., hypokalemia, hypocalcemia, hypomagnesemia)
13. History of chronic liver disease (e.g., cirrhosis) or suspected alcohol abuse
14. History of hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)
15. Administration of live vaccine <6 weeks before entry on study
16. Evidence of uncontrolled current serious active infection (including sepsis, bacteremia, fungemia) or patients with a recent history (within 4 months) of deep tissue infections such as fasciitis or osteomyelitis
17. Patients who have had a severe allergic reaction or anaphylactic reaction to any humanized monoclonal antibodies or any known hypersensitivity to the active substance or any of its excipients
18. Pregnant females; breastfeeding females; males and females of childbearing potential (a woman is considered of childbearing potential (WOCBP) i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile e.g. after hysterectomy or bilateral ovariectomy. Please refer to chapter 12.4 Contraceptive Requirements.) not using highly effective contraception or not agreeing to continue highly effective contraception for women at least 8 months an for men at least 5 months after the last dose of investigational product19. Participation in other studies involving investigational drug(s) (Phase I-IV) within 4 weeks before study inclusion20. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Studienteilnehmende Mindestalter
56 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
ALL - Akute lymphatische Leukämie
Medizinischer Befund
Acute lymphoblastic leukemia, Philadelphia-chromosome and BCR-ABL negative disease, patient aged 56 years or older
MedDRA Term
Acute lymphoblastic leukemia
Roche WO39608
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Monozentrisch
A Study to Evaluate the Efficacy and Safety of Multiple Immunotherapy-Based Treatments Combinations in Patients with Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
EudraCT-Nummer: 2016-004126-42
Zurück
Roche WO39608
Studieninformationen
Studien-Code
UME-ID-7573
Studien-Akronym
Roche WO39608
Studientitel
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
Kurzbeschreibung
A Study to Evaluate the Efficacy and Safety of Multiple Immunotherapy-Based Treatments Combinations in Patients with Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2018,2019,2020,2021,2023
EudraCT-Nummer: 2016-004126-42
Beteiligte
Institute
Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Jens Siveke

jens.siveke@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

F. Hoffmann- La Roche Ltd.

Studiendesign
randomisiert, kontrolliert, Monozentrisch, International
Einschlusskriterien
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed metastatic PDAC
- For patients in Cohort 1: no prior systemic treatment for PDAC
- For patients in Cohort 2: disease progression during administration of either of 5-fluorouracil or gemcitabine-based first-line chemotherapy in the metastatic or locally advanced setting and, for patients treated in the locally advanced setting, occurrence of metastasis within 6 months after initiation of chemotherapy
- Life expectancy >=3 months
- Availability of a representative tumor specimen that is suitable for determination of programmed death ligand 1 (PD-L1) and/or additional biomarker status via central testing
- Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Adequate hematologic and end-organ function test results
- Tumor accessible for biopsy
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive, and agreement to refrain from donating eggs, measures as outlined for each specific treatment arm
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm
Ausschlusskriterien
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
- Positive HIV test at screening or at any time prior to screening
- Active hepatitis B or C virus infection or active tuberculosis
- Severe infection within 4 weeks prior to initiation of study treatment
- Prior allogeneic stem cell or solid organ transplantation
- History of malignancy other than pancreatic carcinoma within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Tumoren der Leber und Bauchspeicheldrüse und der Gallenwege
Medizinischer Befund
Pancreatic ductal adenocarcinoma
BMS CA209-908
Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Subjects with High Grade Primary CNS Malignancies
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
An Investigational Immuno-therapy Study of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Patients with High Grade Primary CNS Malignancies.
EudraCT-Nummer: 2016-004441-82
Zurück
BMS CA209-908
Studieninformationen
Studien-Code
UME-ID-7619
Studien-Akronym
BMS CA209-908
Studientitel
Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Subjects with High Grade Primary CNS Malignancies
Kurzbeschreibung
An Investigational Immuno-therapy Study of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Patients with High Grade Primary CNS Malignancies.
Aktueller Studienstatus
Geschlossen
Studie aktiv in den Jahren
2018,2021
EudraCT-Nummer: 2016-004441-82
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Gudrun Fleischhack

+49 (0)201 / 723 84667
gudrun.fleischhack@uk-essen.de

Hufelandstr. 55
45147 Essen

Sponsor

Bristol-Myers Squibb Research and Development, USA

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
1-Children and adolescents diagnosed with either:
_Diffuse Intrinsic Pontine Glioma (DIPG),
_High Grade Glioma (HGG),
_Medulloblastoma,
_Ependymoma, or
_Other high-grade tumors of the central nervous system.
2-Lansky play score (LPS) for = 16 years of age assessed within two weeks of enrollment must be >= 60.
3-A tumor sample must be available for submission to central laboratory [not required for DIPG].
Ausschlusskriterien
1-Participants with active, known or suspected autoimmune disease.
2-Participants unable to taper steroids due to ongoing mass effect.
3-Participants with low-grade gliomas or tumors of unknown malignant potential.
4-Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors).
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
Primary central nervous system (CNS) malignancies.
MedDRA Term
Brain tumor
GMMG-CONCEPT
Eine klinische Phase II Studie zur Induktions-, Konsolidierungs- und Erhaltungstherapie mit Isatuximab, Carfilzomib, Lenalidomid und Dexamethason (I-KRd) in der Primärtherapie des Hochrisikomyeloms
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
A Clinical Phase II, multicenter, Open-label study evaluating iNduction, consolidation and maintenance treatment with Isatuximab (SAR650984), Carfilzomib, LEnalidomide and Dexamethasone (I-KRd) in Primary diagnosed high-risk multiple myeloma patients
EudraCT-Nummer: 2016-000432-17
Zurück
GMMG-CONCEPT
Studieninformationen
Studien-Code
UME-ID-7621
Studien-Akronym
GMMG-CONCEPT
Studientitel
Eine klinische Phase II Studie zur Induktions-, Konsolidierungs- und Erhaltungstherapie mit Isatuximab, Carfilzomib, Lenalidomid und Dexamethason (I-KRd) in der Primärtherapie des Hochrisikomyeloms
Kurzbeschreibung
A Clinical Phase II, multicenter, Open-label study evaluating iNduction, consolidation and maintenance treatment with Isatuximab (SAR650984), Carfilzomib, LEnalidomide and Dexamethasone (I-KRd) in Primary diagnosed high-risk multiple myeloma patients
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2018,2019,2020,2021,2022
EudraCT-Nummer: 2016-000432-17
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Jan Dürig

+49 (0)201 723-82530
Jan.Duerig@sjk.uk-essen.de

Sponsor

Universitätsklinikum Tübingen

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, National
Einschlusskriterien
1. Subjects must have newly diagnosed, untreated, symptomatic (according to the revised CRAB criteria 2014), documented myeloma and have measurable disease (serum M-protein ≥ 1 g/dL (for IgA ≥ 0.5 g/dL) or urine M-protein ≥ 200 mg/24 hours) or in case of oligosecretory myeloma: involved FLC level ≥ 10 mg/dl, provided sFLC ratio is abnormal or in case of asecretory myeloma: > 1 focal lesions measurable by MRI
Subjects must have high-risk myeloma defined as followed:
• Presence of one or more of the following cytogenetic abnormalities (determined by FISH):
- Del(17p) in ≥ 10% of purified cells
- t(4;14)
- > 3 copies +1q21
- - t(14;16)
• ISS Stage II or III (all patients)
FISH analysis of external laboratories other than Heidelberg is accepted, a list of laboratories will be filed in the study central.
2. Must be ≥ 18 years at the time of signing the informed consent form.
3. Must be able to adhere to the study visit schedule and other protocol requirements in the investigators opinion.
4. WHO performance status 0-3 (WHO=3 is allowed only if caused by MM and not by co-morbid conditions)
5. Females of childbearing potential (FCBP) (1) must agree to refrain from becoming pregnant for 28 days prior to initiation of study drug, while on study drug and for 30 -150 days* after discontinuation from the study drug by using 2 reliable methods of contraception and must agree to regular pregnancy testing during this timeframe.
(1) A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months) 3) has achieved menarche at some point.
6. Females must agree to abstain from breastfeeding during study participation and 30 150 days* after study drug discontinuation.
7. Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 90 150 days* following discontinuation from this study, even if he has undergone a successful vasectomy.
8. Males must also agree to refrain from donating semen or sperm while on treatment with any study drug and for 90 150 days* after discontinuation from this study treatment.
9. All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment.
10. All subjects must agree not to share medication.
11. All participating subjects have to follow the requirements of the Lenalidomide Pregnancy Prevention Plan (please refer to section 4)
*28 days after last dose of Lenalidomide, 30 days after last dose of Carfilzomib and 150 days (5 Months) after last dose of Isatuximab, for detailsnumber of days differ for Lenalidomide and Carfilzomib, for details see chapter 4.
Ausschlusskriterien
1. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize Carfilzomib), mannitol, sucrose, histidine (as base and hydrochloride salt) and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
2. Patients with known systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow)
3. Administration of systemic chemotherapy, biological, immunotherapy or any investigational agent (therapeutic or diagnostic) for multiple myeloma except bisphosphonate therapy. Emergency treatment with dexamethasone is allowed when the cumulative dexamethasone dose is less or equal 160 mg. It is allowed to include patients in the trial after 1 cycle (4 weeks) of any anti-myeloma first-line treatment.
4. Any of the following laboratory abnormalities:
o Absolute neutrophil count (ANC) < 1,000/µL, unless related to myeloma
o Platelet count < 30,000/ µL (in case of platelets < 50.000 /µl and = 30.000 /µl myeloma bone marrow infiltration should be = 50%)
o Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L); or free ionized calcium > 6.5 mg/dL (> 1.6 mmol/L)
o Serum GOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN) or serum total bilirubin > 2.0 mg/dL if not due to hereditary abnormalities as Gilbert’s disease or hereditary hemolysis (Note: if the mentioned limits for bilirubin or ASAT/ALAT are exceeded, but there is no significant hepatic dysfunction at investigator’s discretion, the study office has to be consulted prior to inclusion)
o Patients with severe renal impairment (eGFR < 30 ml/min/1.73 m², MDRD formula or CDK-EPI or Creatinine Clearance < 30 ml/min)
5. Active congestive heart failure (NYHA Class III to IV), symptomatic cardiac ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior study entry.
6. Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B sAg and core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed). Patients with a history of hepatitis B infection have to be monitored repetively during treatment. In case of signs of hepatitis B reactivation, antiviral treatment has to be initiated and patients have to be referred to a specialist for treatment and monitoring of hepatitis infection.
7. Acute active, uncontrolled infection
8. Significant neuropathy (Grades 3 to 4, or Grade 2 with pain according CTC V4.03)
9. Second malignancy within the past 5 years except:
- adequately treated basal cell or squamous cell skin cancer
- carcinoma in situ of the cervix
- prostate cancer Gleason Score = 6 with stable PSA over the past 12 months
- breast carcinoma in situ with full surgical resection
- treated medullary or papillary thyroid cancer
10. Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to study entry.
11. Major surgery within 4 weeks prior to cycle 1 day 1 (kyphoplasty is not considered major surgery); subjects should have been fully recovered from any surgical related toxicities.
12. Female patients who are pregnant or lactating
13. Any other clinically significant medical disease or psychiatric condition that, in the Investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent.
14. Participation in any other clinical trial (with the exclusion of observational, non-interventional studies))
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
MM - Multiples Myelom
Medizinischer Befund
Multiple myeloma
MedDRA Term
Plasma cell myeloma
CheckMate 914: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 914
A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
A study comparing nivolumab monotherapy or the combination of nivolumab and ipilimumab vs placebo in participants with localized Renal Cell Carcinoma.
EudraCT-Nummer: 2016-004502-34
Zurück
CheckMate 914: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 914
Studieninformationen
Studien-Code
UME-ID-7662
Studien-Akronym
CheckMate 914: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 914
Studientitel
A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
Kurzbeschreibung
A study comparing nivolumab monotherapy or the combination of nivolumab and ipilimumab vs placebo in participants with localized Renal Cell Carcinoma.
Aktueller Studienstatus
Geschlossen
Studie aktiv in den Jahren
2018,2019,2020,2021
EudraCT-Nummer: 2016-004502-34
Beteiligte
Institute
Klinik für Urologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Viktor Grünwald

+49 (0)201 723-3213
urologie.studien@uk-essen.de

Hufelandstr. 55
45147 Essen

Sponsor

Bristol-Myers Squibb International Corporation, Belgien

Studiendesign
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
Einschlusskriterien
a) Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy. Partial nephrectomy is allowed provided all inclusion criteria are met.
b) Post-nephrectomy tumor shows RCC with a predominately clear cell histology, including participants with sarcomatoid features.
c) Pathological TNM staging per AJCC staging version 2010:
i) pT2a, G3 or G4, N0M0
ii) pT2b, G any, N0M0
iii) pT3, G any, N0M0
iv) pT4, G any, N0M0
v) pT any, G any, N1M0d) Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases (M0) after nephrectomy
i) Baseline tumor assessment, performed 4 to approximately 12 weeks after nephrectomy, shows no metastasis or residual tumor lesions per local review and as confirmed by Blinded Independent Central Review (BICR). Results of BICR of the baseline tumor assessment confirming absence of metastasis or residual tumor lesions must be received before randomization.Note: participants with one or more regional lymph nodes identified with short axis 15 mm on the baseline (post-operative) tumor assessments are considered to have gross residual disease and are therefore ineligible.
e) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
f) Either a formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor tissue sections, obtained within 3 months prior to enrollment, preferably from nephrectomy, with an associated pathology report, must be submitted to the central laboratory prior to randomization. FFPE block or 20 unstained slides is ideal, but a minimum of 10 unstained slides will be acceptable if tumor tissue is limited. Biopsy should be excisional, incisional, or core needle. Fine needle aspiration is unacceptable for submission
Ausschlusskriterien
a) Any severe or serious, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration including ongoing or active infection requiring parental antibiotics
b) Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Topical, ocular, intra-articular, intranasal, inhaled steroids, and adrenal replacement steroid doses > 10 mg daily prednisone or theequivalent are permitted in the absence of active immune disease.
c) Uncontrolled adrenal insufficiencyd) Participants with an active known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Indikation
Urogenitale Tumore
Medizinischer Befund
Early stage localized Renal Cell Carcinoma
MedDRA Term
Renal carcinoma
NAUT
Multicenter prospective trial after first unsuccesful treatment discontinuation in chronic myeloid leukemia estimating the efficacy of nilotinib in inducing the persistance of molecular remission after stopping tyrosine kinase inhibitors a second time
Arzneimittelgesetz (AMG) / Phase 2, Interventionell
Stopping tyrosine kinase inhibitors a second time after first unsuccesful treatment discontinuation in chronic myeloid leukemia
EudraCT-Nummer: 2015-004998-33
Zurück
NAUT
Studieninformationen
Studien-Code
UME-ID-7865
Studien-Akronym
NAUT
Studientitel
Multicenter prospective trial after first unsuccesful treatment discontinuation in chronic myeloid leukemia estimating the efficacy of nilotinib in inducing the persistance of molecular remission after stopping tyrosine kinase inhibitors a second time
Kurzbeschreibung
Stopping tyrosine kinase inhibitors a second time after first unsuccesful treatment discontinuation in chronic myeloid leukemia
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021
EudraCT-Nummer: 2015-004998-33
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Joachim Göthert

+49 (0)201 723-82530
joachim.goethert@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Universitätsklinikum Heidelberg

Studiendesign
Einschlusskriterien
• Age ≥ 18 years
• Patients with Ph -chromosome and/or the BCR-ABL fusion gene (either b3a2 and/or b2a2) positive CML
• CML in CP having failed a prior attempt to stop imatinib or other TKIs therapy either within EURO-SKI or not
• Pretreatment at least one year with any TKI after 1st stop
• Written informed consent
Ausschlusskriterien
• Vorheriger hämatologischer Rückfall nach dem ersten TKI-Absetzversuch.
• Versagen jeglichen TKIs entsprechend den aktuellen ELN-Kriterien zu jeglicher Zeit während der CML-Behandlung.
• Vorherige geplante oder durchgeführte allogene Stammzell-transplantation.
• Entwicklung zur akzelerierten Phase oder Blastenkrise zu jeglicher Zeit in der Krankheitsgeschichte.
• Hohes Risiko für Herzerkrankungen entsprechend dem ESC score.
• Beeinträchtigte Herzfunktion oder einer der folgenden (Vor)Geschichten:
• Verwendung eines ventrikulär stimulierten Herzschrittmachers; angeborenes oder in der Familienanamnese vorkommendes Lang-QT-Syndrom; signifikante ventrikuläre oder Vorhof-Tachyarrhythmien in der Vergangenheit oder Gegenwart; klinisch signifikante Ruhe-Bradykardie ( 450 ms zu Studienbeginn, Myokardinfarkt vor Studienbeginn; andere klinisch signifikante Herzkrankheiten (beispielsweise instabile Angina pectoris, Herzinsuffizienz oder nicht beherrschbarer Bluthochdruck),
• Eine Behandlung mit CYP3A4-Inhibitoren oder mit Medi-kamenten, bei denen dokumentiert ist, dass diese die QT- Intervall verlängern, ist kontraindiziert,
• Eine akute Pankreatitis innerhalb eines Jahres vor Studienbeginn oder eine chronische Pankreatitis in der Vorgeschichte,
• Positiver serologischer Hepatitis B Virus Test oder HBV Infektion
• Alle anderen bösartige Erkrankungen, außer diese sind weder klinisch signifikant oder erfordern kein aktives Eingreifen,
• Schwerwiegende oder nicht beherrschbare medizinische Zustände (beispielsweise nicht beherrschbare Diabetes, akute oder chronische Lebererkrankungen, Bauchspeicheldrüsen- oder schwere Nierenerkrankung in keinem Zusammenhang mit einem Tumor, aktive oder nicht beherrschbare Infektionen),
• Frauen, die schwanger sind, stillen, oder im gebärfähigem Alter sind und keinen negativen Schwangerschaftstest zu Beginn der Studie aufweisen. Männliche oder weibliche Patienten im gebärfähigen Alter, die nicht bereit sind, eine wirksame Schwangerschaftsverhütungsmethode zu verwenden.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
CML - chronische myeloische Leukämie
Medizinischer Befund
CML-Patients in chronic phase having failed a prior attempt to stop imatinib or other TKIs therapy either within EURO-SKI or not and are pretreated at least one year with any TKI after 1st stop
AMPLIFY-NEOVAC
AMPLIFYing NEOepitope-specific VACcine Responses in progressive diffuse glioma: a randomized, open label, 3 arm multicenter Phase I trial to assess safety, tolerability and immunogenicity of IDH1R132H-specific peptide vaccine in combination with checkpoint inhibitor Avelumab (AMPLIFY-NEOVAC)
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
EudraCT-Nummer: 2017-000587-15
Zurück
AMPLIFY-NEOVAC
Studieninformationen
Studien-Code
UME-ID-7867
Studien-Akronym
AMPLIFY-NEOVAC
Studientitel
AMPLIFYing NEOepitope-specific VACcine Responses in progressive diffuse glioma: a randomized, open label, 3 arm multicenter Phase I trial to assess safety, tolerability and immunogenicity of IDH1R132H-specific peptide vaccine in combination with checkpoint inhibitor Avelumab (AMPLIFY-NEOVAC)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022,2023
EudraCT-Nummer: 2017-000587-15
Beteiligte
Institute
Klinik für Neurologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Glas

neuroonkologie@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

German Cancer Research Center, Heidelberg

Studiendesign
randomisiert, offen, Multizentrisch, National
Einschlusskriterien
- Age ≥ 18 years, smoking or non-smoking, of any ethnic origin and gender
- Patients present with unequivocal first, second or third recurrence of a histologically confirmed IDH1R132H-mutated glioma WHO grade II, III or IV progressive after radiotherapy and chemotherapy
- Absence of chromosomal 1p/19q co-deletion in the primary tumor tissue and/or
- Loss of nuclear ATRX expression in the primary tumor tissue (partial loss allowed)
- Availability of tumor tissue for analysis (FFPE bulk tissue)
- Patients have received radiotherapy (54 - 60 Gy) and at least six months of alkylating chemotherapy
- Patients are at least three months off radiotherapy
- Patients must be candidates for re-resection and the re-resection must be postponable for seven weeks
- Patients should be immunocompetent (i.e. no concomitant treatment with dexamethasone (or equivalent), or receive stable/decreasing steroid levels not exceeding 2 mg/day dexamethasone (or equivalent) during the last 3 days prior to clinical screening; no severe lymphopenia)
- Karnofsky Performance Status ≥ 70
- Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
- Ability of patient to understand character and individual consequences of the clinical trial
- Evidence of informed consent document personally signed and dated by the patient (or a witness in case the patient is unable to write) and indicating that the patient has been informed of all pertinent aspects of the study and that the patient consents to participate in the trial
- Women of child-bearing potential (WOCBP; i.e. those who have not undergone a hysterectomy, bilateral salpingectomy and bilateral oophorectomy or who have not been post-menopausal for at least 24 consecutive months) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of the investigational medicinal product(s) (IMPs).
- WOCBP must be using an effective method of birth control to avoid pregnancy throughout the study and for 3 months after the last dose of the IMP. This includes two different forms of effective contraception (e.g. hormonal contraceptive and condom, IUD/IUS and condom) or sterilization, resulting in a failure rate less than 1% per year.
- Men must be willing and able to use an effective method of birth control throughout the study for up to 3 months after the last dose of the IMP(s), if their sexual partners are WOCBP (acceptable methods see above).
- Availability of pre-study MRT (magnetic resonance tomography) of latest tumor recurrence
- Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Ausschlusskriterien
- Current use of immunosuppressive medication, EXCEPT for the following:
1. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
2. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent;
3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- Pregnancy or lactation
- Previous or concurrent experimental treatment for the tumor other than radiotherapy and alkylating chemotherapy. This includes local therapies such as interstitial radiotherapy or local chemotherapy (i.e. BCNU wafers), loco-regional hyperthermia, electric fields, and antiangiogenic therapy (such as Bevacizumab).
- Abnormal (= Grade 2 CTCAE v4.03) laboratory values for thyroid gland: free T4 and TSH
- Abnormal (= Grade 2 CTCAE v4.03) laboratory values for hematology, liver and renal function (serum creatinine). In detail, the following values apply as exclusion criteria:
1. Hemoglobin < 9 g/dL (5.59 mmol/L)
2. White blood cell count (WBC) decrease ( 10.0 x 109/L)
3. Absolute neutrophil count (ANC) decrease (< 1.5 x 109/L)
4. Platelet count decrease (< 100 x 109/L)
5. Bilirubin > 1.5 x ULN (upper limit of normal according to the performing lab´s reference range)
6. ALT > 2,5 x ULN
7. AST > 2,5 x ULN
8. GGT > 2.5 x ULN
9. Serum creatinine increase (> 1.5 x ULN)
- Patients with history or presence of HIV and/or HBV/HCV positivity (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
- Patients with history or known presence of tuberculosis (positive QuantiFERON®-TB Gold test (or equivalent) or tuberculin skin test). Patients with an indeterminate result of the QuantiFERON®-TB Gold test (or equivalent) are not eligible unless additional testing demonstrates a negative result (tuberculin skin test or repeated QuantiFERON®-TB Gold test/or equivalent). If a tuberculin skin test is performed, an induration of > 6 mm is "positive" for a patient with history of BCG vaccine, while an induration of > 10 mm is "positive" for a patient without history of BCG vaccine. If necessary, a QuantiFERON®-TB Gold or equivalent test might be complemented by additional specific diagnostic tests as per standard procedures.
- Patients with severe infection(s) or signs/symptoms of infection within 2 weeks prior to the first administration of the study drug(s)
- Active infection requiring systemic therapy
- Patients who have received a live, attenuated vaccine within 4 weeks prior to the first administration of the study drug(s)
- Patients with a prior solid organ transplantation or haematopoietic stem cell transplantation
- Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
- Clinically significant (i.e., active) cardiovascular disease: Cerebral vascular accident/stroke (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina, congestive heart failure (= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Persisting toxicity related to prior therapy (NCI CTCAE v.4.03 Grade >1); however, alopecia, sensory neuropathy Grade = 2, or other persisting toxicities Grade = 2 not constituting a safety risk based on investigator´s judgement is acceptable.
- Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade = 3).
- Participation in other clinical trials or their observation period during the last 30 days before the first administration of the IMP(s).
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
NONKO - Neuroonkostudien
Medizinischer Befund
Malignant Glioma
GliProPh
Randomisierte Studie zum Vergleich einer Protonen- vs. Photonen- Strahlentherapie für Patienten mit WHO Grad II-III Gliomen (GliProPh)
Berufsordnung (BO) / Interventionell, Multizentrisch
Zurück
GliProPh
Studieninformationen
Studien-Code
UME-ID-7914
Studien-Akronym
GliProPh
Studientitel
Randomisierte Studie zum Vergleich einer Protonen- vs. Photonen- Strahlentherapie für Patienten mit WHO Grad II-III Gliomen (GliProPh)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2019,2020,2021,2022,2023
Beteiligte
Institute
Klinik und Poliklinik für Strahlentherapie, Klinik für Neurologie, Westdeutsches Protonentherapiezentrum (WPE), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Glas

neuroonkologie@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Universitätsklinik Essen (AöR)

+49 (0)201 723-0
info@uk-essen.de

Hufelandstraße 55
45147 Essen

Studiendesign
randomisiert, offen, Multizentrisch
Einschlusskriterien
• Histologisch gesichertes WHO Grad II oder III Gliom mit Indikation zur Durchführung einer Strahlentherapie nach Beschluss der lokalen neuroonkologischen Konferenz des Studienzentrums
• Klassifikation des Tumors gemäß der WHO-Klassifikation 2016 inkl.: mutierter IDH-Status muss nachgewiesen sein, Bestimmung des 1p/19q Deletionsstatus und MGMT- Promotormethylierungsstatus muss vorliegen
• Ein Karnofsky-Index von ≥ 70%
• Patienten müssen ≥ 18 Jahre sein
• Beginn der Strahlentherapie innerhalb 6 Wochen nach Operation
• Zum Zeitpunkt des Studieneinschlusses sollte der Abstand zur letzten Operation ≥ 2 Wochen sein. Die Patienten müssen sich von den Folgen der Operation erholt haben
• Patient muss zustimmen und in der Lage sein eine neurokognitive Baseline-Testung noch vor Gabe der ersten Strahlendosis durchzuführen
• Der Patient muss vor Studieneinschluss die schriftliche Einwilligung zur Studienteilnahme erteilen
• Studienpatient ist in der Lage Sinn und Tragweite der Studie zu verstehen und ist gewillt den Anweisungen der klinischen Studie zu folgen und aller Voraussicht nach die geplanten Studienvisiten einzuhalten.
• Gebährfähige Patientinnen müssen einen negativen Schwangerschaftstest (aus dem Serum oder Urin) aufweisen, der nicht älter als 7 Tage ist zum Zeitpunkt der ersten Studienintervention.
• Laborwerte nicht älter als 3 Wochen vor Studieneinschluss: Absolutwert neutrophiler Granulozyten ≥ 1500/mm³, Thrombozytenzahl ≥ 100 000/mm³, Hämoglobinwert (Hb) >10 g/dL, Gesamtbilirubinwert ≤ 1,5-fach der oberen Normwertgrenze, Werte für Aspartat-Aminotransferase (AST) und Alanin-Aminotransferase (ALT) ≤ 3-fach der oberen Normwertgrenze, Kreatininwert ≤ 1,5-fach der oberen Normwertgrenze
Ausschlusskriterien
• Gleichzeitige Teilnahme an einer anderen klinischen Studie oder Teilnahme an einer klinischen Studie, die die Gabe eines Prüfpräparats innerhalb von 30 Tagen vor Studieneinschluss erfordert.
• Physischer oder psychischer Zustand des Patienten, der, im Ermessen des Studienarzts, den Patienten gefährden könnte, die Studienergebnisse verfälschen könnte oder der die Teilnahme des Patienten an der klinischen Studie negativ beeinflussen könnte.
• Bekannter oder anhaltender Missbrauch von Drogen, Alkohol oder Medikamenten.

Indikationsspezifische Ausschlusskriterien:
• Vorausgegangene Strahlentherapie am Kopf oder im Gesichts-Halsbereich
• Vorausgegangene Chemotherapie aufgrund einer ZNS Neoplasie
• Schwere Komorbidtät, die eine Compliance mit den Studienvorgaben limitiert
• Bösartige invasive Tumorerkrankung mit einer Tumorfreiheit von < 3 Jahren
• Hinweise für eine leptomeningeale Dissiminierung
• Spinale oder infratentorielle Tumorlokalisation
• Patienten mit bekannter Infektion mit dem humanen Immundefizienz-Virus (HIV) und unter laufender retroviraler Therapie.
• Patienten mit neuerlich diagnostizierter Hepatitis-Infektion oder - nach Ermessen des zuständigen Studienarztes - erheblichem Risiko einer Reaktivierung
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
NONKO - Neuroonkostudien
Medizinischer Befund
Gliom
AMoRe2017
INTERNATIONAL MULTICENTER, OPEN-LABEL, PHASE 2 STUDY TO TREAT MOLECULAR RELAPSE OF PEDIATRIC ACUTE MYELOID LEUKEMIA WITH AZACITIDINE
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
Study to treat the molecular relapsed of AML patients in childhood with Azacitidine
EudraCT-Nummer: 2017-003422-32
Zurück
AMoRe2017
Studieninformationen
Studien-Code
UME-ID-7940
Studien-Akronym
AMoRe2017
Studientitel
INTERNATIONAL MULTICENTER, OPEN-LABEL, PHASE 2 STUDY TO TREAT MOLECULAR RELAPSE OF PEDIATRIC ACUTE MYELOID LEUKEMIA WITH AZACITIDINE
Kurzbeschreibung
Study to treat the molecular relapsed of AML patients in childhood with Azacitidine
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2018,2021,2022
EudraCT-Nummer: 2017-003422-32
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Dirk Reinhardt

+49 (0)201 723-3784
dirk.reinhardt@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

German Pediatric Oncology Group, GPOH gGmbH, Berlin

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
1. Aged 3 months to <21 years with documented diagnosis of AML according to WHO classification with at least one quantitative genetic maker, e.g. one of the following aberrations:• t(8;21); RUNX1/RUNX1T1 • inv(16); CBFb/MYH11 • t(9;11); MLL/AF9 • t(10;11); MLL/AF10 • NPM1 • WT1; etc.2. Molecular remission confirmed at the start of last consolidation course or within 1 month after completion of consolidation treatment3. Detection of a confirmed molecular relapse of an AML4. Understand and voluntarily provide permission (subjects and when applicable, parental/legal representative(s)) to the ICF prior to conducting any study related assessments/procedures5. Able to adhere to the study visit schedule and other protocol requirements6. Lansky performance score at least equal to 50; or Karnofsky performance status at least equal to 50, whichever is applicable7. Negative serum pregnancy tests for females of child bearing potential within 10 days prior to treatment
Ausschlusskriterien
1. Concomitant treatment with any other anticancer therapy except those specified in protocol2. HSCT within previous 3 months3. Treated by any investigational agent in a clinical study within previous 4 weeks4. Pregnancy or lactating5. FAB type M3 leukemia (acute promyelocytic leukemia)6. Therapy-related AML7. AML of Down syndrome or other congenital syndromes giving rise to leukemia or treatment complications8. Symptomatic cardiac disorders (CTCAE 4.0 Grade 3 or 4)9. Evidence of invasive fungal infection or other severe systemic infection requiring treatment doses of systemic/parenteral therapy including known active viral infection with human immunodeficiency virus (HIV) or Hepatitis Type B and C10. Any other organ dysfunction (CTCAE 4.0 Grade 3 or 4) that will interfere with the administration of the therapy according to this protocol11. Ongoing severe toxicities (CTCAE 4.0 Grade 3 or 4) of prior chemotherapy/stem cell transplantation12. Hypersensitivity to azacitidine13. Abnormal liver function: • serum bilirubin > 3 x ULN • ALT or AST > 5 times ULN14. Symptomatic CNS-involvement or isolated extramedullary disease at initial diagnosis15. Female and male subjects with child bearing potential who avoid to use secure anti-conceptive measurements
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
Intravenous azacitidine 100 mg\/m2, Days 1 to 7 of a 28-day cycle for up to 3 cycles initially. In case of decline of MRD during azacitidine treatment additional cycles are allowed (maximum 6 cycles).
AIEOP-BFM ALL 2017
AIEOP-BFM ALL 2017 - International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia
EudraCT-Nummer: 2016-001935-12
Zurück
AIEOP-BFM ALL 2017
Studieninformationen
Studien-Code
UME-ID-8015
Studien-Akronym
AIEOP-BFM ALL 2017
Studientitel
AIEOP-BFM ALL 2017 - International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia
Kurzbeschreibung
International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2018,2019,2020,2021,2022,2023
EudraCT-Nummer: 2016-001935-12
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Dirk Reinhardt

+49 (0)201 723-3784
dirk.reinhardt@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
- newly diagnosed acute lymphoblastic leukemia or- newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria:
• biphenotypic with a dominant T or B lineage assignment
• bilineal either with a dominant lymphoblastic population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen
- newly diagnosed acute undifferentiated leukemia
- age < 18 years (up to 17 years and 365 days) at the day of diagnosis- patient enrolled in a participating center
- written informed consent to trial participation and transfer and processing of data
Ausschlusskriterien
- Ph+ (BCR-ABL1 or t(9;22)-positive) ALL
- bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (= 10% of total cells) blast subset
- pre-treatment with cytostatic drugs- glucocorticoid pre-treatment with = 1 mg/kg/d Prednisolone equivalent for more than two weeks during the last month before diagnosis
- treatment started according to another protocol- underlying diseases that does not allow treatment according to the protocol - ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
- evidence of pregnancy or lactation period
- Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
- participation in another clinical trial that interferes with the protocol
- other condition (either pre-existing or related to leukemia biology as present at diagnosis) or circumstances that significantly conflict with the treatment according to the protocol
Studienteilnehmende Höchstalter
17 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
acute lymphoblastic leukemia in children and adolescents <18 yearsof age
EndoPro
Prospektive Untersuchung der Langzeitauswirkungen einer kranialen Protonentherapie bei Erwachsenen mit Hirn- und Schädelbasis-Tumoren auf die endokrine Funktion von Hypothalamus und Hypophyse
Berufsordnung (BO) / Nicht-interventionell, Monozentrisch
Nach der Behandlung von Hirn- und Schädelbasis-Tumoren mit einer Strahlentherapie kann es zu Störungen im Hormonhaushalt kommen, da die Hypophyse und der Hypothalamus bei diesen Tumoren in oder nahe der bestrahlten Region liegen. Diese Störungen können gravierende gesundheitliche Folgen haben. Ziel dieser Studie ist es, bei erwachsenen Patienten, die eine Strahlentherapie mit Protonen im Bereich des Kopfes erhalten, die Auswirkungen…
Zurück
EndoPro
Studieninformationen
Studien-Code
UME-ID-8040
Studien-Akronym
EndoPro
Studientitel
Prospektive Untersuchung der Langzeitauswirkungen einer kranialen Protonentherapie bei Erwachsenen mit Hirn- und Schädelbasis-Tumoren auf die endokrine Funktion von Hypothalamus und Hypophyse
Kurzbeschreibung
Nach der Behandlung von Hirn- und Schädelbasis-Tumoren mit einer Strahlentherapie kann es zu Störungen im Hormonhaushalt kommen, da die Hypophyse und der Hypothalamus bei diesen Tumoren in oder nahe der bestrahlten Region liegen. Diese Störungen können gravierende gesundheitliche Folgen haben. Ziel dieser Studie ist es, bei erwachsenen Patienten, die eine Strahlentherapie mit Protonen im Bereich des Kopfes erhalten, die Auswirkungen auf die hormonelle Funktion zu untersuchen.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2019,2020,2021,2022,2023,2024
Beteiligte
Institute
Westdeutsches Protonentherapiezentrum (WPE), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Beate Timmermann

beate.timmermann@uk-essen.de

Am Mühlenbach 1
45147 Essen

Sponsor

WPE gGmbH, Essen

Studiendesign
Monozentrisch
Einschlusskriterien
- Alter ≥18 Jahren bei Beginn der Protonentherapie
- Diagnose eines Hirntumors oder eines Tumors an der Schädelbasis
- Protonentherapie mit rechtfertigender Indikation und Einverständnis zur Protonentherapie
- Teilnahme an Registerstudie Erwachsene des WPE (ProReg) mit entsprechender Einwilligung
- unterschriebene Einwilligungserklärung zur Studie
Ausschlusskriterien
- Re-Bestrahlung
- vollständiger HVL Ausfall und Diabetes insipidus
- Grad 4-Gliome
- Vorliegen von Fernmetastasen (M+ bzw. M1)
Studienteilnehmende Mindestalter
18 Jahr(e)
Indikation
Diverse
Medizinischer Befund
Diagnose eines Hirn- oder Schädelbasistumors
VFR-PROJEKT
Vulvafeldresektion mit therapeutischen inguinalen Lymphonodektomie und anatomische Rekonstruktion: Neues operatives Konzept für die Lokalbehandlung des Vulvakarzinoms ohne adjuvante Strahlentherapie
Berufsordnung (BO) / Interventionell, Multizentrisch
Im Rahmen dieser Studie wird ein neues Operationsprinzip zur Behandlung des Vulvakarzinoms (Schamlippenkrebs) erprobt. Die Operationstechnik basiert auf der Beobachtung, dass sich Krebs bevorzugt in Geweben ausbreitet, welche embryologisch verwandt sind. Diese Gewebe werden gezielt entfernt. Wir nehmen an, dass sich daraus eine höhere Überlebenschance ergibt. Darüber hinaus entfällt die Notwendigkeit einer Bestrahlung nach der Operation. In allen Fällen wird…
Zurück
VFR-PROJEKT
Studieninformationen
Studien-Code
UME-ID-8045
Studien-Akronym
VFR-PROJEKT
Studientitel
Vulvafeldresektion mit therapeutischen inguinalen Lymphonodektomie und anatomische Rekonstruktion: Neues operatives Konzept für die Lokalbehandlung des Vulvakarzinoms ohne adjuvante Strahlentherapie
Kurzbeschreibung
Im Rahmen dieser Studie wird ein neues Operationsprinzip zur Behandlung des Vulvakarzinoms (Schamlippenkrebs) erprobt. Die Operationstechnik basiert auf der Beobachtung, dass sich Krebs bevorzugt in Geweben ausbreitet, welche embryologisch verwandt sind. Diese Gewebe werden gezielt entfernt. Wir nehmen an, dass sich daraus eine höhere Überlebenschance ergibt. Darüber hinaus entfällt die Notwendigkeit einer Bestrahlung nach der Operation. In allen Fällen wird eine Rekonstruktion der Schamlippen und des Scheideneingangs durchgeführt. Vielversprechende Ergebnisse der Studie konnten bereits publiziert werden. Seit Frühjahr 2018 wird die Studie an mehreren Standorten durchgeführt.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2019,2020,2021,2024
Beteiligte
Institute
Klinik für Frauenheilkunde und Geburtshilfe, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med Pawel Mach

pawel.mach@uk-essen.de

Hufelandstr 55
45147 Essen

Studiendesign
nicht-kontrolliert, Multizentrisch, National
Einschlusskriterien
Vulvakarzinom im Stadium oT1-oT3b,
Vorliegen der schriftlichen Einwilligungserklärung zur Studienteilnahme
Ausschlusskriterien
Hochgradig eingeschränkter Allgemeinzustand (Karnovsky-Index <80%),
Komorbidität welche mit der Durchführung der Operation nicht vereinbar ist,
Fernmetastasen
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Weiblich
Indikation
Gynäkologische Tumore
Medizinischer Befund
Vulvakarzinom
Roche CO40115
A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST CANCER (MORPHEUS-TNBC)
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
A Study to Evaluate Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Triple-Negative Breast Cancer (MORPHEUS-TNBC)
EudraCT-Nummer: 2017-002038-21
Zurück
Roche CO40115
Studieninformationen
Studien-Code
UME-ID-8060
Studien-Akronym
Roche CO40115
Studientitel
A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST CANCER (MORPHEUS-TNBC)
Kurzbeschreibung
A Study to Evaluate Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Triple-Negative Breast Cancer (MORPHEUS-TNBC)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2018,2019,2021
EudraCT-Nummer: 2017-002038-21
Beteiligte
Institute
Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Anja Welt

anja.welt@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

F. Hoffmann-La Roche AG

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
Stage 1
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Metastatic or inoperable locally advanced, histologically documented TNBC
- For patients in the 1L PD-L1 positive cohort: no prior systemic treatment for metastatic or inoperable locally advanced TNBC
- For patients in the 2L CIT-naïve cohort: Eligible for capecitabine monotherapy
- For patients in the 2L CIT-naïve cohort: Radiologic/objective evidence of recurrence or disease progression after 1L treatment with chemotherapy (chemo) for a total of one line of therapy for inoperable locally advanced or metastatic breast cancer
- Life expectancy>= 3 months
- Availability of a representative tumor specimen that is suitable for determination of Programmed death-ligand 1and/or additional biomarker status via central testing
- For patients in the 1L PD-L1 positive cohort: positive PD-L1 expression, defined as >= 1%of the tumor area occupied by PD-L1- expressing tumor-infiltrating immune cells of any intensity Stage 1 and Stage 2
- Measurable disease according to Response Evaluation Criteria in Solid Tumors 1.1
- Tumor accessible for biopsy
- Adequate hematologic and end-organ function
- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen during the 14 days prior to initiation of study treatment
- Negative HIV test, hepatitis B surface antigen at screening, and hepatitis C virus (HCV) antibody test or positive HCV antibody test followed by a negative HCV RNA test at screening
- Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) DNA < 500 IU/mL at screening
- For women of childbearing potential: agreement to remain abstinent or use treatment arm-specific contraceptive measures and agreement to refrain from breastfeeding and donating eggs
- For men: agreement to remain abstinent or use treatment arm- specific contraceptive measures, and agreement to refrain from donating sperm for a treatment arm-specific time period Stage 2
- ECOG Performance Status of 0, 1, or 2
- Patients randomly allocated to the control arm during Stage 1: ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity, provided that Medical Monitor approval for entry into Stage 2 is obtained, or disease progression per RECIST v1.1 while receiving control treatment
- Patients randomly allocated to an experimental arm during Stage 1: ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab (Atezo), disease progression per RECIST v1.1, or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment
- Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1
Ausschlusskriterien
Stage 1
- Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies
- Treatment with investigational therapy within 28 days prior to C1D1
- Biologic treatment or other systemic treatment within 2 weeks (wks) prior to C1D1
- Eligibility only for the control arm Stage 1 (2L CIT naïve cohort only)
- Prior treatment with capecitabine
Stage 1, 2
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, tumor-related pain and uncontrolled or symptomatic hypercalcemia
- Symptomatic, untreated, or actively progressing central nervous system metastases.
- History of leptomeningeal disease, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis or tuberculosis on screening and malignancy other than breast cancer within 2 years prior to screening.
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- History of autoimmune disease or immune deficiency
- Grade >= 3 hemorrhage or bleeding event within 28 days prior to
C1D1
- Severe infection within 4 wks prior C1D1
- Major surgical procedure within 4wks
- Treatment with antibiotics or live, attenuated vaccine within 2 wks or 4wks prior to C1D1 respectively
- Treatment with systemic immunostimulatory agents within 4wks or 5 half-lives of the drug prior to C1D1
- Patients entering Stage 2: immunotherapy-related adverse events that have not resolved to Grade 1 or better or to baseline at the time of consent Ipatasertib (Ipat) - Containing arm (Stage 1)
- Prior treatment with ipat or other Akt inhibitors
- Grade >= 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceremia
- History of Type I or Type II diabetes mellitus requiring insulin
- Congenital long QT syndrome or screening QT interval corrected through use of Fridericia's formula > 480ms
- Treatment with strong CYP3A4 inducers or inhibitors within 2wks or 5 drug-elimination half-lives prior to C1D1. SGN-LIV1A - Containing arm (Stage 1)
- Prior treatment with SGN-LIV1A or MMAE -based biologic
- Grade>= 2 neuropathy
- Radiotherapy within 2wks prior to C1D1
- AST/ALT > 1.5 x ULN, or 3 x ULN if liver metastases present
- Documented history of a cerebrovascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure, within 6 months prior to study enrollment. Bevacizumab (Bev) - Containing arm (Stage 1)
- Inadequately controlled arterial hypertension
- History of hypertensive crisis or hypertensive encephalopathy
- Significant vascular disease within 6 months prior to C1D1
- History of hemoptysis within 1 month prior to C1D1 and abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intraabdominal abscess and intestinal obstruction and/or clinical signs or symptoms of GI obstruction and intra-abdominal inflammatory process within 6 months prior to C1D1.
- Radiotherapy within 28 days or abdominal/pelvic radiotherapy within 60 days prior to C1D1
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to C1D1; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to C1D1 Selicrelumab (Seli)– containing arm (Stage 1)
- Soluble CD25 > 2 x ULN
- Serum ferritin > 1000 ng/mL
- Known hereditary or acquired coagulopathy
- Concomitant treatment with anticoagulants Chemo – containing arm (Stage 2)
- Inability to tolerate atezo during Stage 1 and Patients with congenital long QT syndrome
Exclusion Criteria for the Nab-Paclitaxel-Containing Arms (Stage 1)
- Grade >= 2 neuropathy related to taxanes
Exclusion Criteria for the Tocilizumab-Containing Arm (Stage 1)
- Preexisting CNS demyelinating or seizure disorders
- History of diverticulitis, chronic ulcerative lower GI disease, or other symptomatic lower GI conditions that might predispose a patient to GI perforation
- Current liver disease unrelated to the underlying cancer diagnosis
- Active current infection or history of recurrent bacterial, viral, fungal, mycobacterial, or other infection, including, but not limited to, TB, atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of the nail bed
- Active TB as documented by a positive purified protein derivative (PPD) skin test or TB blood test and confirmed by a positive chest X-ray within 3 months prior to initiation of study treatment
- Untreated latent TB
- History of, or currently active, primary or secondary immunodeficiency
- ALT or AST > 1.5 xULN or, for patients with liver metastases, > 3 x ULN
- Total bilirubin > ULN
Exclusion Criteria for the Sacituzumab Govitecan- Containing Arm (Stage 1)
- Prior treatment with a topoisomerase 1 inhibitor
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Brustkrebs
Medizinischer Befund
Triple-negative breast cancer (TNBC)
MedDRA Term
Triple negative breast cancer
NeuroID
Psychoonkologische Wirksamkeit einer EEG Neurofeedback-Intervention bei Menschen mit malignem Melanom
Berufsordnung (BO) / Interventionell
Im Rahmen dieser Studie wurden psychoonkologische Patient*innen nach einer fünfwöchigen Warteliste randomisiert einer von zwei Interventionsbedingungen (Neurofeedback vs. Achtsamkeit) zugeteilt. Fragebogenerhebungen sowie EEG-Untersuchungen wurden vor der Warteliste, vor und nach der fünfwöchigen Intervention, sowie bei einem Follow-Up nach weiteren fünf Wochen durchgeführt.
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NeuroID
Studieninformationen
Studien-Code
UME-ID-8079
Studien-Akronym
NeuroID
Studientitel
Psychoonkologische Wirksamkeit einer EEG Neurofeedback-Intervention bei Menschen mit malignem Melanom
Kurzbeschreibung
Im Rahmen dieser Studie wurden psychoonkologische Patient*innen nach einer fünfwöchigen Warteliste randomisiert einer von zwei Interventionsbedingungen (Neurofeedback vs. Achtsamkeit) zugeteilt. Fragebogenerhebungen sowie EEG-Untersuchungen wurden vor der Warteliste, vor und nach der fünfwöchigen Intervention, sowie bei einem Follow-Up nach weiteren fünf Wochen durchgeführt.
Aktueller Studienstatus
Geschlossen
Studie aktiv in den Jahren
2021,2023
Beteiligte
Institute
Klinik für Dermatologie, LVR Kliniken-Essen - Klinik für Psychosomatische Medizin und Psychotherapie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Frau Madeleine Fink

+49 (0)201 7227-208
Madeleine.fink@uni-due.de

Virchowstr 174
45147 Essen

Studiendesign
Indikation
Melanom
Medizinischer Befund
malignes Melanom
PONS
Phase 2 Clinical Trial with Ponatinib as a Second Line Therapy for Patients with Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to prior First Line Tyrosine Kinase Inhibitor Treatment
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
EudraCT-Nummer: 2016-000618-30
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PONS
Studieninformationen
Studien-Code
UME-ID-8204
Studien-Akronym
PONS
Studientitel
Phase 2 Clinical Trial with Ponatinib as a Second Line Therapy for Patients with Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to prior First Line Tyrosine Kinase Inhibitor Treatment
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021
EudraCT-Nummer: 2016-000618-30
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Joachim Göthert

+49 (0)201 723-82530
joachim.goethert@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

GWT-TUD GmbH, Dresden

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch
Ausschlusskriterien
1. Andere Erstlinien Anti CML Behandlung als TKI Therapie (ausgenommen die Therpie mit Hydroxyurea).
2. Andre Zweitlinien-Therapien mit einem Tyrosinkinase Inhibitor (> 1 EMA zugelassener TKI gegen CML, oder jeder andere investigative von der EMA nicht zugelassene TKI)
3. Gleichzeitige Teilnahme an einer weiteren klinischen Prüfung mit einer anderen klinischen Prüfsubstanz innerhalb 4 Wochen vor Beginn und während der gesamten Dauer der Teilnahme an der PONS-Studie
4. Herzerkrankungen die nach NYHA den Klassen 3-4 zuzuordnen sind
5. Kardiale Symptome innerhalb der letzten 12 Monate vor Eintritt in die Studie: Patienten mit folgenden Kriterien sind für die Studie nicht geeignet:
? Krankengeschichte die eine instabile Angina Pectoris, Myocard-Infarkt , TIA, Schlaganfall, periphere arterielle Verschlusserkrankungen oder Lungenempolie aufweisen
? Krankengeschichte mit klinisch signifikanten ventrikulären Arrhythmien (wie zum Beispiel ventrikuläre Tachykardie, ventrikuläre Fibrillation, oder Torsades de pointes)
? Verlängerung des QTc Intervalls im EKG (>450 ms bei Männern, > 470 ms bei Frauen) nach der Friderica-Formel
? Herzinsuffizienz (NYHA Klasse III oder IV) innerhalb von 3 Monaten vor der ersten Dosis Ponatinib.
6. Patienten mit aktiven unkontrollierten psychischen Störungen, einschließlich von Psychosen, schweren Depressionen und bipolaren Störungen
7. Patienten mit unkontrollierter Hypertonie (definiert als anhaltender systolischer Blutdruck > 140 mmHg oder diastolisch > 90 mmHg)
8. Schwangere oder stillende Frauen sind ausgeschlossen.
9. Patienten, die in der Vergangenheit an einer Pankreatitis gelitten haben
10. Patienten in der akzelerierten oder in der Blastenphase, sowie Patienten, bei denen jemals/überhaupt die Blastenphase nachgewiesen werden konnte, sind von der Studie ausgeschlossen. Die von der Studie ausgeschlossenen CML-Phasen sind wie folgt definiert:
? Blastenphase: 30% Blasten oder mehr im peripheren Blut oder im Knochenmark
? Akzelerierte Phase der CML: Bestehen eines oder mehrerer der folgenden Kriterien:
? 15% Blasten im peripheren Blut oder im Knochenmark
? 20% Basophile im peripheren Blut oder im Knochenmark
? nicht Therapie-bedingte Thrombozytopenie < 100 x 109/L
? Nachgewiesene extramedulläre Blastenerkrankung außerhalb der Leber oder der Milz
? Klonale Evolution definiert als das Vorhandensein zusätzlicher Chromosomenannomalien außer dem Ph- Chromosom, wurde historisch als ein Kriterium für die Akzelerierte Phase einbezogen. Patienten jedoch, bei denen die klonale Evolution als einziges Kriterium für die akzelerierte Phase festgestellt wurde, haben eine signifikant bessere Prognose. Daher können Patienten mit klonaler Evolution als einzigem Kriterium für die akzelerierte Phase und keinerlei weiteren Kriterien, in die Studie aufgenommen werden, müssen aber separat analysiert werden.
11. Patienten, die eine Unverträglichkeit gegenüber dem Wirkstoff oder einem der anderen Bestandteile der Prüfsubstanz aufweisen.
12. Patienten, die aufgrund einer gerichtlichen oder verwaltungsbehördlichen Anordnung in einer Anstalt untergebracht sind
13. Patienten, die vom Sponsor, der Prüfstelle oder dem Prüfer anhängig sind,
Studienteilnehmende Mindestalter
18 Jahr(e)
Indikation
CML - chronische myeloische Leukämie
Medizinischer Befund
Adult patients (age = 18) with Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) who have proven to be resistant or intolerant to prior first line Tyrosine Kinase Inhibitor Treatment
TRACE
Therapie refraktärer Virusinfektionen nach allogener Stammzelltransplantation mit multispezifischen T-Zellen gegen CMV, EBV und ADV: eine Phase III, prospektive, multizentrische klinische Studie
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
Bekämpfung von Virusinfektionen nach Stammzelltransplantation mit speziellen Abwehrzellen
EudraCT-Nummer: 2018-000853-29
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TRACE
Studieninformationen
Studien-Code
UME-ID-8318
Studien-Akronym
TRACE
Studientitel
Therapie refraktärer Virusinfektionen nach allogener Stammzelltransplantation mit multispezifischen T-Zellen gegen CMV, EBV und ADV: eine Phase III, prospektive, multizentrische klinische Studie
Kurzbeschreibung
Bekämpfung von Virusinfektionen nach Stammzelltransplantation mit speziellen Abwehrzellen
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021
EudraCT-Nummer: 2018-000853-29
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Dr. med. Stefan Schönberger

stefan.schoenberger@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Klinikum der Universität München

Studiendesign
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
Einschlusskriterien
1. Adult or paediatric patients (>2 months of age) after HSCT suffering from new or reactivated CMV, EBV or AdV infection and refractory to standard antiviral treatment for two weeks (defined as =1 log decrease in viral load over two weeks) as confirmed by quantitative blood PCR analysis
2. Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory infection
3. Written informed consent given (patient or legal representative)
Ausschlusskriterien
1. Acute GvHD > grade II or extensive chronic GvHD at time of T-cell transfer
2. Treatment with steroids (>1 mg/kg Prednisone equivalent) at Screening
3. Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP infusion until 8 weeks post IMP infusion. In case of T-cell depleted HSCT, a prescheduled prophylactic DLI =3 x 10e5 T cells/kg BW is not considered an exclusion criteria.
4. Organ dysfunction or failure as determined by Karnofsky (age >16 years) or Lansky (age =16 years) score =30%
5. Concomitant enrolment in another clinical trial interfering with the endpoints of this study
6. Any medical condition which could compromise participation in the study according to the investigator’s assessment
7. Progression of underlying disease (disease that has led to the indication of HSCT, e.g. leukaemia) that will limit the life expectance below the duration of the study
8. Second line or experimental antiviral treatment other than Ganciclovir/Valganciclovir, Foscarnet, Cidofovir and Rituximab from Screening until 8 weeks after IMP infusion
9. Known HIV infection. In case patients do not have a negative HIV test performed within 6 months before enrolment in the study, HIV negativity has to be confirmed by a negative laboratory test.
10. Female patient who is pregnant or breast-feeding, or adult of reproductive potential not willing to use an effective method of birth control from Screening until the last follow-up visit (FU6, Visit 8) Note: women of childbearing potential must have a negative serum pregnancy test at study entry
11. Known hypersensitivity to iron dextran
12. Patients unwilling or unable to comply with the protocol or unable to give informed consent.
Studienteilnehmende Mindestalter
3 Monat(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
Chemo-refactory AdV, CMV and EBV infections after allogeneic stem cell transplantation
MedDRA Term
Allogenic stem cell transplantation, Cytomegalovirus infection, Adenovirus infection, Epstein-Barr virus infection
KiAPT
Die "KiAPT"-Studie: Eine prospektive Evaluation der Adaptiven, Hochpräzisions-ProtonenradioTherapie bei Kindern mit Tumoren im Kopf-Hals-Bereich
Berufsordnung (BO) / Interventionell, Monozentrisch
Im Rahmen dieser Studie soll der Nutzen der bildgeführten adaptiven Protonentherapie (APT) bei Kindern mit Tumoren im Bereich des Gesichts, des Halses und der Schädelbasis ermittelt werden. Ziel ist, zu evaluieren, inwieweit eine bessere Schonung der gefährdeten Normalgewebsstrukturen („Risikoorgane“) durch eine Anpassung und Verkleinerung des bestrahlten Volumens mithilfe der APT erreicht werden kann. Daraus würde in der Folge eine weitere…
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KiAPT
Studieninformationen
Studien-Code
UME-ID-8320
Studien-Akronym
KiAPT
Studientitel
Die "KiAPT"-Studie: Eine prospektive Evaluation der Adaptiven, Hochpräzisions-ProtonenradioTherapie bei Kindern mit Tumoren im Kopf-Hals-Bereich
Kurzbeschreibung
Im Rahmen dieser Studie soll der Nutzen der bildgeführten adaptiven Protonentherapie (APT) bei Kindern mit Tumoren im Bereich des Gesichts, des Halses und der Schädelbasis ermittelt werden. Ziel ist, zu evaluieren, inwieweit eine bessere Schonung der gefährdeten Normalgewebsstrukturen („Risikoorgane“) durch eine Anpassung und Verkleinerung des bestrahlten Volumens mithilfe der APT erreicht werden kann. Daraus würde in der Folge eine weitere Verminderung des Risikos für relevante Nebenwirkungen resultieren.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021,2022,2023
Beteiligte
Institute
Westdeutsches Protonentherapiezentrum (WPE), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Beate Timmermann

beate.timmermann@uk-essen.de

Am Mühlenbach 1
45147 Essen

Studiendesign
Monozentrisch, National
Einschlusskriterien
o Kinder im Alter <18 Jahre
o PT am WPE mit rechtfertigender Indikation und Einverständnis zur PT
o Einschluss in das WPE Register KiProReg (13-5544-BO, Ethikvotum 10.09.2013)
o Histologische gesicherte Tumoren im Bereich des Gesichts, des Hals oder der Schädelbasis (z.B. Sarkome wie Rhabdomyosarkom, Ewing´s Sarkom; außerdem Karzinome inklusive Ästhesioneuroblastom)
o Keine Vorbestrahlung
o unterschriebene Einwilligungserklärung zur KiAPT-Studie
Ausschlusskriterien
o Alter =18 Jahre
o Keine schriftliche Einwilligung zu dem Vorgehen und Datenerhebung
o Behandlung in palliativer Intention
o Folgende Histologie: Retinoblastome, Lymphom, primäre Tumoren des zentralen Nervensystems
Studienteilnehmende Höchstalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Kopf-Hals-Tumore
EsPhALL2017/COGAALL1631
International phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
International trial in Philadelphia chromosome-positive acute lymphoblastic leukemia
EudraCT-Nummer: 2017-000705-20
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EsPhALL2017/COGAALL1631
Studieninformationen
Studien-Code
UME-ID-8329
Studien-Akronym
EsPhALL2017/COGAALL1631
Studientitel
International phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones
Kurzbeschreibung
International trial in Philadelphia chromosome-positive acute lymphoblastic leukemia
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021,2022,2023
EudraCT-Nummer: 2017-000705-20
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Dr. Stephan Tippelt

2768
stephan.tippelt@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Università degli Studi Milano Bicocca, Italien

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
1. Enrollment on National ALL protocol.
2. Age > 1 year and = 21 years at ALL diagnosis.
3. Newly diagnosed ALL (B-ALL or T-ALL) or mixed phenotypicacute leukemia (MPAL meeting 2016 WHO definition) with definitive evidence of BCR-ABL1 fusion by karyotype, FISH and/or RT-PCR.
4. Previous start of Induction therapy which includes vincristine, a corticosteroid, usually PEG-L-Asparaginase, with or without anthracycline, and/or other standard cytotoxic chemotherapy.
5. Administration of no more than 14 days of multiagent Induction therapy beginning with the first dose of vincristine.
6. Administration of no more than 14 days of imatinib.
7. Performance status corresponding to ECOG scores of 0, 1, or 2.
8. Adequate liver function.
9. Adequate cardiac function.
10. Adequate renal function.
Ausschlusskriterien
1. Known history of chronic myelogenous leukemia (CML).
2. ALL developing after a previous cancer treated with cytotoxic chemotherapy.
3. Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation.
4. Down syndrome.
5. Pregnancy.
6. Breast feeding.
7. Patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.
8. Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block.
9. Prior treatment with dasatinib, or any BCR-ABL1 inhibitor other than imatinib.
Studienteilnehmende Mindestalter
1 Jahr(e)
Studienteilnehmende Höchstalter
21 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
Philadelphia positive Acute Lymphoblastic Leukemia
MedDRA Term
Philadelphia chromosome positive, Acute lymphoblastic leukaemia
SAKK
Neoadjuvante und adjuvante Kombinationstherapie von Durvalumab mit der neoadjuvanten Standardchemotherapie bei Patienten mit einem operablen Urothelkarzinom. Eine multizentrische einarmige Phase II Studie.
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
Behandlung zur Beeinflussung der Aktivität des Immunsystems in Kombination mit einer Chemotherapiebehandlung bei Patienten mit operablen Urothelkarzinom
EudraCT-Nummer: 2017-003565-10
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SAKK
Studieninformationen
Studien-Code
UME-ID-8339
Studien-Akronym
SAKK
Studientitel
Neoadjuvante und adjuvante Kombinationstherapie von Durvalumab mit der neoadjuvanten Standardchemotherapie bei Patienten mit einem operablen Urothelkarzinom. Eine multizentrische einarmige Phase II Studie.
Kurzbeschreibung
Behandlung zur Beeinflussung der Aktivität des Immunsystems in Kombination mit einer Chemotherapiebehandlung bei Patienten mit operablen Urothelkarzinom
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2019,2021
EudraCT-Nummer: 2017-003565-10
Beteiligte
Institute
Klinik für Urologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Boris Hadaschik

+49 (0)201 723-3213
urologie.studien@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Swiss Group for Clinical Cancer Research, Schweiz

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
- Histologisch bestätigtes Urothelkarzinom =T2 (=N1, M0) der Blase, Harnröhre, oder des oberen Harntrakts, als geeignet eingestuft für die kurative multimodale Behandlung inklusive Operation durch ein multidisziplinäres Tumor-Board
- Alle histologischen Subtypen sind geeignet, wenn das Urothelkarzinom vorherrschend ist
- WHO Performance Status (Allgemeinzustand) 0-1
- adäquate Knochemarksfunktion, Leber- Nieren- Herzfunktion
Ausschlusskriterien
• pathologischer Nachweis einer kleinzelligen Karzinomkomponente
• Vorhandensein von Fernmetastasen
• Jegliche Vorbehandlung mit einem PD-1- oder PD-L1-Inhibitor, inklusive Durvalumab
• Aktuelle oder frühere Therapie mit immunsupprimierenden Medikamenten innerhalb von 28 Tagen vor Registrierung
• Aktive oder frühere dokumentierte Autoimmunerkrankungen oder entzündliche Erkrankungen
• Medizinische Vorgeschichte einer Infektion mit Humanem Immundefizienz-Virus (HIV) oder aktiver chronischer Hepatitis C oder Hepatitis B Virusinfektion
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Urogenitale Tumore
Medizinischer Befund
muskelinvasives Urothelkarzinom
MedDRA Term
Urothelial carcinoma
PREPARE
A phase III study testing the role of proactive coaching on patient reported outcome in advanced or metastatic renal cell carcinoma treated with sunitinib [PREPARE]
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
EudraCT-Nummer: 2016-000399-28
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PREPARE
Studieninformationen
Studien-Code
UME-ID-8453
Studien-Akronym
PREPARE
Studientitel
A phase III study testing the role of proactive coaching on patient reported outcome in advanced or metastatic renal cell carcinoma treated with sunitinib [PREPARE]
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2020,2021,2022,2023
EudraCT-Nummer: 2016-000399-28
Beteiligte
Institute
Klinik für Urologie, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Viktor Grünwald

+49 (0)201 723-3213
urologie.studien@uk-essen.de

Hufelandstr. 55
45147 Essen

Sponsor

AIO-Studien-gGmbH, Berlin

Studiendesign
randomisiert, offen, Multizentrisch
Einschlusskriterien
Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Age ≥ 18 years at time of study entry
Advanced or metastatic renal cell carcinoma, not amendable to surgery with curative intent, rendering the patient eligible for Tyrosin Kinase Inhibitor (TKI) treatment with sunitinib
Intended first-line treatment with sunitinib
Documented progressive disease within 6 months prior to study inclusion
Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as well as non-measurable disease are eligible.
Prior radiotherapy and surgery are allowed if completed 4 weeks (for minor surgery and palliative radiotherapy for bone pain: 2 weeks) prior to start of treatment and patient recovered from toxic effects.
Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
Subject is willing to receive additional concomitant coaching and able to comply with the QoL/PRO (patient-reported outcome) assessments specified in the protocol for the duration of the study including scheduled visits, examinations and follow up.
Ausschlusskriterien
Any other anti-cancer treatment aside of sunitinib for mRCC (except palliative radiotherapy)
Previous malignancy (other than mRCC) which either progresses or requires active treatment.

Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a or T1b prostate carcinoma, or superficial bladder tumor [Ta, Tis and T1].

CNS metastases, unless local therapy has been completed for at least 3 month and patient does not require the use of steroids.
Chronic liver disease with Child-Pugh B or C score
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year)
Any condition that, in the opinion of the investigator, would interfere with evaluation of the concomitant coaching or QoL assessments or interpretation of patient safety or study results
Participation in another clinical study with an investigational product during the last 30 days before inclusion
Any previous treatment with a tyrosine kinase inhibitor for metastatic disease. Adjuvant or neoadjuvant therapy for localized disease is permitted, provided that relapse occurred at least 6 months after last exposure
Previous enrollment or randomization in the present study (does not include screening failure).
Involvement in the planning and/or conduct of the study (applies to both Pfizer staff and/or staff of sponsor and study site)
Patient who might be affiliated or otherwise dependent on the sponsor, site or the investigator
Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG].
Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Urogenitale Tumore
Medizinischer Befund
advanced or metastatic renal cell carcinoma\nFortgeschrittenes oder metastasiertes Nierenzellkarzinom
MedDRA Term
Renal cell carcinoma stage IV
SACRO
SAcral Chordoma: a Randomized & Observational study on surgery versus definitive radiation therapy in primary localized disease (SACRO)
Berufsordnung (BO) / Interventionell, Multizentrisch
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SACRO
Studieninformationen
Studien-Code
UME-ID-8492
Studien-Akronym
SACRO
Studientitel
SAcral Chordoma: a Randomized & Observational study on surgery versus definitive radiation therapy in primary localized disease (SACRO)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021,2022,2023
Beteiligte
Institute
Westdeutsches Protonentherapiezentrum (WPE), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Beate Timmermann

beate.timmermann@uk-essen.de

Am Mühlenbach 1
45147 Essen

Sponsor

Italian Sarcoma Group

Studiendesign
randomisiert, offen, Multizentrisch, International
Einschlusskriterien
- Histologically confirmed diagnosis (brachyury expression) of primary sacral chordoma,of any diameter and arising at any site from S1 to coccyx.
- Age≥18years
- ECOG-performance status (PS) 0-2
- No previous antineoplastic therapy
- Macroscopic tumor detectable at MRI/CT scan
- Patient amenable for surgery
- Patient amenable for RT
- Written informed consent given before the enrolment, according to International Conference on Harmonisation/good clinical practice (ICH/GCP).
Ausschlusskriterien
- Distant metastasis
- Inability to maintain treatment position
- Prior radiotherapy to the pelvic region
- Prior therapy for sacral chordoma (including surgery, cryoablation, hyperthermia, etc)
- Local conditions that increase the risk of RT toxicity (tumor ulcerated skin infiltration, non-healing soft tissue infection, fistula in treatment field)
- Rectal wall infiltration
- General conditions that increase the risk of RT toxicity (active sclerodermia, xeroderma pigmentosum, cutaneous porphyria)
- Presence of a second active cancer (with the exception of non-melanoma skin cancer in-situ cervix neoplasia and other in-situ neoplasia)
- Severe comorbidities resulting in a prognosis of less than 6 months
- Inability to give informed consent
- Other malignancy within the last 5 years
- Performance status = 2 (ECOG).
- Significant cardiovascular disease (for example, dyspnea > 2 NYHA)
- Significant systemic diseases grade >3 on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity
- Women who are pregnant or breast-feeding
- Psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent
Studienteilnehmende Mindestalter
18 Jahr(e)
Studienteilnehmende Höchstalter
80 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Sarkome
Medizinischer Befund
Chordoma
PHITT
Paediatric Hepatic International Tumour Trial
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
Paediatric Hepatic International Tumour Trial
EudraCT-Nummer: 2016-002828-85
Zurück
PHITT
Studieninformationen
Studien-Code
UME-ID-8525
Studien-Akronym
PHITT
Studientitel
Paediatric Hepatic International Tumour Trial
Kurzbeschreibung
Paediatric Hepatic International Tumour Trial
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2021,2022
EudraCT-Nummer: 2016-002828-85
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Michael Schündeln

+49 (0)201 723-2500
michael.schuendeln@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

University of Birmingham, UK

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
For Trial Entry:
• Clinical diagnosis of HB or histologically defined diagnosis of HB or HCC.
• Age =30 years
• Written informed consent for trial entryFor Allocation/Randomisation to Treatment Group:All Groups
• Written Informed Consent for trial treatment participation
• Patient assessed as fit to receive group specific treatment
• For females of child-bearing potential, a negative pregnancy test prior to trial entry is required. Any patient who is of reproductive age must agree to use adequate contraception for the duration of the trial.Group A (no treatment arm)
At diagnosis:
• Resected Tumour.
• Patient meets Very Low Risk definition according to CHIC guidelines.

Group A1 – No treatment arm
• Central pathology review confirming WDF histology.Group A2 - Treatment arm
• Central pathology review confirming non-WDF histology.
• Adequate renal function determined by:o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate(GFR) =60mL/min/1.73m2
• Adequate haematology:
o Absolute neutrophil count (ANC) >0.75 x 109/Lo Platelet count >75 x 109/L
o International normalised ratio (INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values
Group B
• Patient meets Low Risk definition according to CHIC Guidelines
• Adequate renal function determined by:
o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate(GFR) =60mL/min/1.73m2
• Adequate haematology:
o Absolute neutrophil count (ANC) >0.75 x 109/L
o Platelet count >75 x 109/L
o International normalised ratio (INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference valueso K, Mg, Ca within normal range for age

Group C
• Patient meets Intermediate Risk definition according to CHIC Guidelines
• Adequate renal function determined by:
o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate(GFR) =60mL/min/1.73m2
• Adequate cardiac function determined by:o Shortening fraction =28% by local assessment methodo OR Ejection fraction =47% by local assessment method
• Adequate haematology:
o Absolute neutrophil count (ANC) >0.75 x 109/L
o Platelet count >75 x 109/L
o International normalised ratio (INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference valueso K, Mg, Ca within normal range for age

Group D
• Patient meets High Risk definition according to CHIC Guidelines
• Adequate renal function determined by:o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate(GFR) =60mL/min/1.73m2
• Adequate cardiac function determined by:
o Shortening fraction =28% by local assessment methodo OR Ejection fraction =47% by local assessment method
• Adequate haematology:
o Absolute neutrophil count (ANC) >0.75 x 109/L
o Platelet count >75 x 109/L
o International normalised ratio (INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference valueso K, Mg, Ca within normal range for age

Group E
• Patient has been diagnosed with HCC
• Tumour has been locally assessed as resectable
• Adequate renal function determined by:
o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate(GFR) =60mL/min/1.73m2
• Adequate cardiac function determined by:
o Shortening fraction =28% by local assessment methodo OR Ejection fraction =47% by local assessment method
• Adequate haematology:
o Absolute neutrophil count (ANC) >0.75 x 109/L
o Platelet count >75 x 109/L
o International normalised ratio (INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference valueso K, Mg, Ca within normal range for age

Group F
• Patient diagnosed with HCC
• Tumour locally assessed as un-resectable, or metastatic HCC disease
• Adequate renal function determined by:
o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate(GFR) =60mL/min/1.73m2
• Adequate cardiac function determined by:
o Shortening fraction =28% by local assessment methodo OR Ejection fraction =47% by local assessment method
• Adequate haematology:
o Absolute neutrophil count (ANC) >0.75 x 109/L
o Platelet count >75 x 109/L
o International normalised ratio (INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference valueso K, Mg, Ca within normal range for ageo Qt/QTc interval =/<450msec for males, =/<470msec for females
Ausschlusskriterien
• Any previous chemotherapy or currently receiving anti-cancer agents
• Recurrent disease
• Previously received a solid organ transplant
• Uncontrolled infection
• Unable to follow the protocol for any reason
• Second malignancy
• Pregnant or breastfeeding womenTreatment

Group Specific Exclusion Criteria

Group C:
• Patients who have known deficiency of dihydropyrimidine dehydrogenase (DPD)

Group D:
• Chronic inflammatory bowel disease and/or bowel obstruction
• Concomitant use with St John’s Wort which cannot be stopped prior to start of trial treatment

Group F:
• Peripheral Sensitive Neuropathy with functional impairment
• Personal or family history of congenital long QT syndrome
• QT/QTc interval >450msec for men and >470msec for women (corrected measurement of QT according to BAZETTformula)
• Patients who are unable to swallow tablets, where an oral solution is not available or approved
Studienteilnehmende Mindestalter
0 Tag(e)
Studienteilnehmende Höchstalter
17 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
Hepatoblastoma and Hepatocellular Carcinoma.
MedDRA Term
Hepatoblastoma, Hepatocellular carcinoma non-resectable, Hepatocellular carcinoma resectable
LBL 2018
LBL 2018 - International cooperative treatment protocol for children and adolescents with lymphoblastic lymphoma
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
LBL 2018 - International cooperative treatment protocol for children and adolescents with lymphoblastic lymphoma
EudraCT-Nummer: 2017-001691-39
Zurück
LBL 2018
Studieninformationen
Studien-Code
UME-ID-8563
Studien-Akronym
LBL 2018
Studientitel
LBL 2018 - International cooperative treatment protocol for children and adolescents with lymphoblastic lymphoma
Kurzbeschreibung
LBL 2018 - International cooperative treatment protocol for children and adolescents with lymphoblastic lymphoma
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021,2022
EudraCT-Nummer: 2017-001691-39
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Michael Schündeln

+49 (0)201 723-2500
michael.schuendeln@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Universitätsklinikum Münster

+49 (0)251 83-55555
info@ukmuenster.de

Albert-Schweitzer-Straße 33
48149 Münster

Studiendesign
randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
Patients meeting the following criteria are eligible to the study (inclusion criteria):
• newly diagnosed lymphoblastic lymphoma
• age <18 years at diagnosis
• patient enrolled in a participating center
• written informed consent of patient (>14 years of age or according to local law and regulation) and parents to trial participation and transfer and processing of data
• Willingness of patients and the investigator/pathologist to provide adequate slides/blocks for reference (molecular)pathology and international pathology panel and/or fresh or fresh frozen samples for genetic risk group stratification if these samples are available after standard diagnostic procedures
Ausschlusskriterien
Patients meeting the following criteria are not eligible to the study (exclusion criteria):
• lymphoblastic lymphoma as secondary malignancy
• non-lymphoma related relevant medical, psychiatric or social conditions incompatible with trial treatment including among others:
- prior organ transplant
- severe immunodeficiency
- demyelinating Charcot-Marie Tooth syndrome
- serious acute or chronic infections, such as HIV, VZV and tuberculosis
- urinary tract infection, cystitis, urinary outflow obstruction, severe renal impairment (creatinine clearance less than 20 ml/min)
- severe hepatic impairment (bilirubin >3 times ULN, transaminases >10 times ULN)
- myocardial insufficiency, severe arrhythmias
- ulcers of the oral cavity and known active gastrointestinal ulcer disease
- known hypersensitivity to any IMP and to any excipient
• steroid pre-treatment with = 1 mg/kg/d for more than two weeks during the last month before diagnosis
• vaccination with live vaccines within 2 weeks before start of protocol Treatment
• treatment started according to another protocol or pre-treatment with cytostatic drugs
• participation in another clinical trial that interferes with the protocol, except NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment, which can run parallel to LBL 2018 without influencing the outcome of this trial (e.g. trials on antiemetics, antibiotics, strategies for psychosocial support)
• evidence of pregnancy or lactation period
• sexually active adolescents not willing to use highly effective contraceptive method (pearl index < 1) until 12 months after end of cytostatic therapy
Studienteilnehmende Mindestalter
0 Tag(e)
Studienteilnehmende Höchstalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
Lymphoblastic lymphoma
MedDRA Term
Lymphoblastic lymphoma
GLORIA
Einarmige Phase 1/2-Dosiseskalationsstudie mit Olaptesed Pegol (NOX-A12) in Kombination mit Bestrahlung in inoperablen oder partiell resezierten, neu diagnostizierten Glioblastoma-Patienten mit unmethyliertem MGMT-Promotor
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
Behandlung des Glioblastoms mit Bestrahlung und Olaptesed Pegol in unmethylierten Patienten
EudraCT-Nummer: 2018-004064-62
Zurück
GLORIA
Studieninformationen
Studien-Code
UME-ID-8601
Studien-Akronym
GLORIA
Studientitel
Einarmige Phase 1/2-Dosiseskalationsstudie mit Olaptesed Pegol (NOX-A12) in Kombination mit Bestrahlung in inoperablen oder partiell resezierten, neu diagnostizierten Glioblastoma-Patienten mit unmethyliertem MGMT-Promotor
Kurzbeschreibung
Behandlung des Glioblastoms mit Bestrahlung und Olaptesed Pegol in unmethylierten Patienten
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021,2022
EudraCT-Nummer: 2018-004064-62
Beteiligte
Institute
Klinik und Poliklinik für Strahlentherapie, Klinik für Neurologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Glas

neuroonkologie@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

NOXXON Pharma AG, Berlin

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, National
Einschlusskriterien
1. Written informed consent
2. Age ≥18 years
3. Patient agreement to diagnostic and scientific work-up of glioblastoma tissue obtained during the preceding surgery or biopsy
4. Patient agrees to subcutaneous port implantation
5. Newly diagnosed, histologically confirmed, supratentorial WHO grade IV glioblastoma
6. Status post biopsy or incomplete resection
7. Unmethylated MGMT promoter status
8. Maximum Eastern Cooperative Oncology Group (ECOG) score 2
9. Estimated minimum life expectancy 3 months
10. Stable or decreasing dose of corticosteroids during the week prior to inclusion
11. The following laboratory parameters should be within the ranges specified:
- Total bilirubin ≤ 1.5 x upper limit normal (ULN)
- Creatinine ≤ 1.5 x ULN or glomerular filtration rate ≥ 60 mL/min/1.73m²
- ALT (alanine transaminase) ≤ 3 x ULN
- AST (aspartate transaminase) ≤ 3 x ULN
12. Female patients of child-bearing potential must have a negative serum pregnancy test within 21 days prior to enrollment and agree to use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly such as contraceptive implants, vaginal rings, sterilization, or sexual abstinence)" during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations)
13. Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP
Ausschlusskriterien
1. Inability to understand and collaborate throughout the study or inability or unwillingness to comply with study requirements
2. Participation in any clinical research study with administration of an investigational drug or therapy within 30 days from screening visit or observation period of competing studies
3. Contra-indication or known hypersensitivity to MRI contrast agents, olaptesed pegol or polyethylene glycol
4. Cytostatic therapy (chemotherapy) within the past 5 years
5. History of other cancers (except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient was disease-free for = 5 years)
6. Clinically significant or uncontrolled cardiovascular disease
7. Prior radiotherapy to the head
8. Any other previous or concomitant experimental glioblastoma treatments
9. Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles
10. Pregnancy or lactation
11. Uncontrolled intercurrent illness; patients must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator's opinion, interfere with the conduct of the study or study evaluations
12. Treatment not initiated within 6 weeks after first biopsy or surgery of glioblastoma
13. Prior enrolment into this study

Exclusion Criteria Expansion Group Arms A and B:
1. Inability to understand and collaborate throughout the study or inability or unwillingness to comply with study requirements
2. Participation in any clinical research study with administration of an investigational drug or therapy within 30 days from screening visit or observation period of competing studies
3. Contra-indication or known hypersensitivity to MRI contrast agents, bevacizumab (Arm A only) olaptesed pegol or polyethylene glycol
4. Planned hypofractionated radiotherapy
5. Cytostatic therapy (chemotherapy) within the past 5 years
6. History of other cancers (except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient was disease-free for = 5 years)
7. Secondary malignancy which is currently active
8. Clinically significant or uncontrolled cardiovascular disease, including
- Myocardial infarction in the previous 12 months
- Uncontrolled angina
- Congestive heart failure (New York Heart Association functional classification of =2)
- Diagnosed or suspected congenital long QT syndrome
- QTc prolongation on an electrocardiogram prior to entry (>470 ms)
- Uncontrolled hypertension (blood pressure = 160/95 mmHg)
- Heart rate <50/min on the baseline electrocardiogram
- History of ventricular arrhythmias of any clinically significant type (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes)
- Cerebrovascular accident
9. Prior radiotherapy to the head
10. Any other previous or concomitant experimental glioblastoma treatments
11. Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles
12. Patients with a history of arterial or venous thrombosis (or any other disease) requiring permanent intake of anticoagulants (Arm A only)
13. Pregnancy or lactation
14. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), diabetes mellitus, or subjects with either of the following: fasting blood glucose (FBG defined as fasting for at least 8 hours) = 200 mg/dL (7.0 mmol/L), or HbA1c = 8%, chronic renal disease, pancreatitis, chronic pulmonary disease, auto-immune diseases, or psychiatric illness/social situations that would limit compliance with study requirements. Patients must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator's opinion, interfere with the conduct of the study or study evaluations
15. Prolongation of coagulation factors = 2.5 x ULN (Arm A only)
16. Treatment not initiated within 6 weeks after first biopsy or surgery of glioblastoma
17. Prior enrolment into this study

Exclusion Criteria Expansion Group Arms C:
1. Inability to understand and collaborate throughout the study or inability or unwillingness to comply with study requirements
2. Participation in any clinical research study with administration of an investigational drug or therapy within 30 days from screening visit or observation period of competing studies
3. Contra-indication or known hypersensitivity to MRI contrast agents olaptesed pegol or polyethylene glycol or pembrolizumab (= Grade 3)
4. Biopsy-only of GBM with less than 20% of tumor removed
5. Presence of extracranial metastatic or leptomeningeal disease
6. Severe hypersensitivity (= Grade 3) to other monoclonal antibodies
7. Receiving immunosuppressive therapy
8. Previous or current treatment with an anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PDL2 agent
9. Planned hypofractionated radiotherapy
10. Cytostatic therapy (chemotherapy) within the past 5 years
11. History of other cancers or secondary malignancy which is currently active (except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient was disease-free for = 5 years)
12. Clinically significant or uncontrolled cardiovascular disease, including
- Myocardial infarction in the previous 12 months
- Uncontrolled angina
- Congestive heart failure (New York Heart Association functional classification of =2)
- Diagnosed or suspected congenital long QT syndrome
- QTc prolongation on an electrocardiogram prior to entry (>470 ms)
- Uncontrolled hypertension (blood pressure = 160/95 mmHg)
- Heart rate <50/min on the baseline electrocardiogram
- History of ventricular arrhythmias of any clinically significant type (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes)
- Cerebrovascular accident
13. Prior radiotherapy to the head
14. Evidence of acute intracranial / intra-tumoral hemorrhage
15. Any other previous or concomitant experimental glioblastoma treatments
16. Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles
17. Pregnancy or lactation
18. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), diabetes mellitus, or subjects with either of the following: fasting blood glucose (FBG defined as fasting for at least 8 hours) = 200 mg/dL (7.0 mmol/L), or HbA1c = 8%, chronic renal disease, pancreatitis, chronic pulmonary disease, auto-immune diseases or psychiatric illness/social situations that would limit compliance with study requirements. Patients must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator's opinion, interfere with the conduct of the study or study evaluations.
19. Received a live vaccine within 30 days prior to the first dose of study drug.
20. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Previously treated brain metastases may participate provided these remain stable
21. Known history of HIV infection, hepatitis B or hepatitis C infection
22. Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
23. History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or current pneumonitis / interstitial lung disease
24. Immunodeficiency diagnosis or receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone) or any other form of immunosuppressive therapy
25. High dose of corticosteroids (> 4mg/day of dexamethasone or equivalent for at least 3 consecutive days) within two weeks prior to the first dose of study drug
26. Treatment not initiated within 6 weeks after first biopsy or surgery of glioblastoma
27. Prior enrolment into this study
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Glioblastom
Medizinischer Befund
Glioblastom
MedDRA Term
Glioblastoma
INFORM2 NivEnt
INFORM2 exploratory multinational phase I/II combination study of Nivolumab and Entinostat in children and adolescents with refractory high-risk malignancies
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
INFORM2 NivEnt, an european clinical trial to determine a safe dose and signs of efficacy of the combination treatment of novolumab and entinostat in children and adolescents with refractory high-risk malignancies
EudraCT-Nummer: 2018-000127-14
Zurück
INFORM2 NivEnt
Studieninformationen
Studien-Code
UME-ID-8630
Studien-Akronym
INFORM2 NivEnt
Studientitel
INFORM2 exploratory multinational phase I/II combination study of Nivolumab and Entinostat in children and adolescents with refractory high-risk malignancies
Kurzbeschreibung
INFORM2 NivEnt, an european clinical trial to determine a safe dose and signs of efficacy of the combination treatment of novolumab and entinostat in children and adolescents with refractory high-risk malignancies
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2022,2023,2024
EudraCT-Nummer: 2018-000127-14
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. Uta Dirksen

+49 (0)201 723-82025
uta.dirksen@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Universitätsklinikum Heidelberg

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
- Children and adolescents with refractory/relapsed/progressive high-risk
- CNS tumors: medulloblastoma, ependymoma, ATRT, ETMR, pediatric high grade glioma (including DIPG) or other pediatric embryonal CNS tumors
OR
- solid tumors: neuroblastoma, nephroblastoma, rhabdoid tumor, embryonal or alveolar rhabdomyosarcoma or other embryonal small round blue cell tumors including pediatric type (bone) sarcoma
OR
Children and adolescents with newly diagnosed high grade glioma (HGG) in the context of a constitutional mismatch repair deficiency syndrome
- No standard of care treatment available
- Age at registration = 6 to = 21 years.
- Molecular analysis for biomarker identification (SNV load, PDL1 mRNA expression, MYC/N amplification) in laboratories complying with DIN EN ISO/IEC 17025 or similar via INFORM molecular diagnostic platform or equivalently valid molecular pipeline.
- Biomarker determined using whole exome sequencing (SNV load), RNA-sequencing (PDL1 mRNA expression) and whole genome sequencing (MYC/N amplification).
- In case molecular analysis was not performed via INFORM Registry molecular pipeline: transfer of molecular data (whole exome and RNA sequencing)
- Time between biopsy/puncture/resection of the current refractory/relapsed/progressive tumor and registration = 12 weeks
- Disease that is measurable as defined by RANO criteria or RECIST v1.1 (as appropriate).
- Life expectancy > 3 months, sufficient general condition score (Lansky = 70 or Karnofsky = 70). Transient states like infections can be accepted, and also stable disabilities resulting from disease/surgery (hemiparesis, amputations etc.) can be accepted and will not be considered for Lansky/Karnofsky assessments.
- Laboratory requirements:
- Hematology: absolute granulocytes = 1.0 × 109/l (unsupported)
platelets = 100 × 109/l
hemoglobin = 8 g/dl or = 5,6 nmol/L
- Biochemistry: Total bilirubin = 1.5 x upper limit of normal (ULN)
AST(SGOT) = 3.0 x ULN
ALT(SGPT) = 3.0 x ULN
serum creatinine = 1.5 x ULN for age
- ECG: normal QTc interval = 480 msec
- Patient is able to swallow oral study medication
- Ability of patient and/or legal representative(s) to understand the character and individual consequences of clinical trial
- Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment. Sexually active women of childbearing potential must agree to use acceptable and appropriate contraception during the study and for at least 6 months after the last study treatment administration. Sexually active male patients must agree to use a condom during the study and for at least 7 months after the last study treatment administration.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Before patient screening and registration, written informed consent, also concerning data and blood transfer, must be given according to ICH/GCP, and national/local regulations.
- No prior therapy with the combination of immune checkpoint inhibitors and HDACi
- BSA = 0.9m2
- Phase I: molecular analysis performed and biomarker status known (mutational load, PD-L1 mRNA expression AND MYC(N) amplification status).
- Phase II: molecular analysis performed, biomarker status known (mutational load, PD-L1 mRNA expression AND MYC(N) amplification status) and stratification according to the following criteria:
- Group A: high mutational load (defined as > 100 somatic SNVs/exome) based on whole exome sequencing
OR
- Group B: high PD-L1 mRNA expression (defined as reads per million total reads per kilobase of exon model (RPKM) > 3) based on RNA sequencing
OR
- Group C: Focal MYC(N) amplification based on whole genome sequencing
OR
- Group D: Patients with biomarker low tumors according to the definitions of group A-C.
Ausschlusskriterien
- Patients with CNS tumors or metastases who are neurologically unstable despite adequate treatment (e.g. convulsions).
- Patients with low-grade gliomas or tumors of unknown malignant potential are not eligible
- Evidence of > Grade 1 recent CNS hemorrhage on the baseline MRI scan.
- Participants with bulky CNS tumor on imaging are ineligible; bulky tumor is defined as:
- Tumor with any evidence of uncal herniation or severe midline shift
- Tumor with diameter of > 6 cm in one dimension on contrast-enhanced MRI
- Tumor that in the opinion of the investigator, shows significant mass effect
- Previous allogeneic bone marrow, stem cell or organ transplantation
- Diagnosis of immunodeficiency
- Diagnosis of prior or active autoimmune disease
- Evidence of interstitial lung disease
- Any contraindication to oral agents or significant nausea and vomiting, malabsorption, or significant small bowel resection that, in the opinion of the investigator, would preclude adequate absorption.
- Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies). Known active hepatitis B (e.g., hepatitis B surface antigen-reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid [qualitative]). Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBc Ab] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to study treatment. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Clinically significant, uncontrolled heart disease
- Major surgery within 21 days of the first dose. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48 hour interval must be maintained before the first dose of the investigational drug is administered.
- Any anticancer therapy (e.g., chemotherapy, HDACi (including valproic acid), DNA methyltransferase inhibitors, other immunotherapy, targeted therapy, biological response modifiers, endocrine anticancer therapy or radiotherapy) within 4 weeks or at least 5 half-lives (whichever is longer) of study drug administration.
- Radiologically confirmed radiotherapy induced pseudoprogression in CNS tumors
- Traditional herbal medicines; these therapies are not fully studied and their use may result in unanticipated drug-drug interactions that may cause or confound the assessment of toxicity. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. For information on CYP substrates and P-gp inhibitors or inducers see section 5.8.
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form (including benzamide) of the investigational medicinal product
- Participation in other ongoing clinical trials.
- Pregnant or lactating females.
- Presence of underlying medical condition (e.g. gastrointestinal disorders or electrolyte disturbances) that in the opinion of the Investigator or Sponsor could adversely affect the ability of the subject to comply with or tolerate study procedures and/or study therapy, or confound the ability to interpret the tolerability of combined administration of entinostat and nivolumab in treated subjects
- Patients receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. The use of physiologic doses of corticosteroids (up to 5 mg/m2/day prednisone equivalent) may be approved after consultation with the Sponsor.
No patient will be allowed to enroll in this trial more than once.
Studienteilnehmende Mindestalter
2 Jahr(e)
Studienteilnehmende Höchstalter
64 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
This trial investigates a novel combination treatment regimen using immune checkpoint inhibition and epigenetic therapy in children with relapsed\/refractory\/progressive high-risk solid tumors or CNS tumors. Thus, this trial focuses on the pediatric population in 4 biomarker-defined cohorts, for which there is no standard of care treatment available.
Make-It
Eine multizentrische Versorgungsstudie zur Überprüfung der potentiellen Zielgruppe und dessen Zufriedenheit mit dem webbasierten Skills- und Achtsamkeitstrainings Make It Training- (Mindfulness and skill based distress reduction training in oncology)
Berufsordnung (BO) / Interventionell
Zurück
Make-It
Studieninformationen
Studien-Code
UME-ID-8643
Studien-Akronym
Make-It
Studientitel
Eine multizentrische Versorgungsstudie zur Überprüfung der potentiellen Zielgruppe und dessen Zufriedenheit mit dem webbasierten Skills- und Achtsamkeitstrainings Make It Training- (Mindfulness and skill based distress reduction training in oncology)
Aktueller Studienstatus
Geschlossen
Studie aktiv in den Jahren
2023
Beteiligte
Institute
LVR Kliniken-Essen - Klinik für Psychosomatische Medizin und Psychotherapie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Dr. Alexander Bäuerle

+49 (0)201 7227-203
Alexander.Baeuerle@uni-due.de

Virchowstraße 174
45147 Essen

Studiendesign
Indikation
Diverse
SEPION
A Multicenter, Phase I/II Study of Sequential Epigenetic and Immune Targeting in Combination With Nab-Paclitaxel/Gemcitabine in Patients With Advanced Pancreatic Ductal Adenocarcinoma.
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
EudraCT-Nummer: 2017-001625-40
Zurück
SEPION
Studieninformationen
Studien-Code
UME-ID-8647
Studien-Akronym
SEPION
Studientitel
A Multicenter, Phase I/II Study of Sequential Epigenetic and Immune Targeting in Combination With Nab-Paclitaxel/Gemcitabine in Patients With Advanced Pancreatic Ductal Adenocarcinoma.
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2020,2021,2022,2023
EudraCT-Nummer: 2017-001625-40
Beteiligte
Institute
Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Jens Siveke

jens.siveke@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

GWT-TUD GmbH, Dresden

Studiendesign
nicht-randomisiert, offen, kontrolliert, Multizentrisch, National
Einschlusskriterien
1. Patients must have histologically confirmed PDAC
2. Patients must have metastatic disease (stage IV) and not received prior chemotherapy for stage IV disease (adjuvant/additive chemotherapy is allowed if completed at least 6 months prior to study inclusion)
3. Patients must not have received the following drugs before: Azacitidine, Romidepsin, any checkpoint-inhibitor or immunomodulating agents such as IMiDs (Lenalidomide)
4. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v. 1.1
5. Male or female, age ≥ 18 years
6. Body weight > 30 kg for inclusion into Part 2 (according to Durvalumab treatment)
7. ECOG performance status 0 or 1
8. Patients must have normal organ and marrow function as defined below
• Leukocytes ≥ 2,5*10^9/L
• Absolute neutrophil count ≥ 1,5*10^9/L
• Platelets ≥ 100*10^9/L
• Haemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) This will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
• Asparate aminotransferase/alanine aminotransferase (AST/ALT) (SGOT/SGPT) ≤ 2.5 x ULN and ≤ 5 in the case of liver metastasis
• Measured creatinine clearance (CL) >60 mL/min or Calculated creatinine CL>60 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
9. Patients must be recovered from the effects of any prior surgery
10. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
11. All subjects must agree to refrain from donating blood while on study drug and for 90 days after discontinuation from this study treatment
12. All subjects must have a life expectancy of at least 12 weeks
13. All subjects must agree not to share medication.
14. Females of childbearing potential (FCBP) must
• Understand the potential teratogenic risk to the unborn child
• Understand the need and agree to utilize two reliable forms of contraception simultaneously without interruption for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 90 days after study treatment discontinuation
• Understand and agree to inform the investigator if a change or stop of method of contraception is needed
• Be capable of complying with effective contraceptive measures
• Be informed and understand the potential consequences of pregnancy and the need to notify her study doctor immediately if there is a risk of pregnancy
• Understand the need to commence the study treatment as soon as study drug is dispensed following a negative pregnancy test
• Understand the need and accept to undergo pregnancy testing based on the frequency outlined in this protocol
• Acknowledges that she understands the hazards Lenalidomide can cause to an unborn fetus and the necessary precautions associated with the use of Lenalidomide
• Females must agree to abstain from breastfeeding during study participation and for at least 90 days after study drug discontinuation
15. Males must
• Understand the potential teratogenic risk if engaged in sexual activity with a pregnant female or a FCBP
• Agree to use a latex condom during any sexual contact with FCBP or a pregnant female while participating in the study and for 90 days following discontinuation from this study, even if he has undergone a successful vasectomy. For treatment with Gemcitabine and nab-Paclitaxel men must avoid fathering a child/ use a condom up to 6 months after their last dose. Depending on duration of Lenalidomide/Durvalumab treatment this period can be longer than 90 days after study discontinuation
• Agree to refrain from donating semen or sperm while on the study drugs and for 90 days after discontinuation from this study treatment. For treatment with nab-Paclitaxel and Gemcitabine male subjects must agree not to father a child or donate semen for at least 6 month afterlast intake of medication
• Agree not to father a child during the course of the trial and for at least 90 days after last administration of study drugs. For Gemcitabine and nab-Paclitaxel treatment up to 6 month after last drug intake.
16. Females of non-childbearing potential:
• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrhea for at least 24 consecutive months without an alternative medical cause
Ausschlusskriterien
1. Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events from agents administered more than 4 weeks earlier
2. Patients receiving any other investigational agents
3. Patients who have previously received Romidepsin, Azacitidine, Lenalidomide or Durvalumab or any PD1 or PD-L1 inhibitor or participate currently on an other clinical trial, unless it is an observational clinical study or during the follow-up period of an interventional study
4. Patients with untreated or uncontrolled brain metastases or leptomeningeal disease
5. Presence of other active illnesses
6. Any known cardiac abnormalities such as:
• Congenital long QT syndrome
• QTc interval = 470 milliseconds. Calculated from 3 ECGs using Fridericias Correction
7. Myocardial infarction within 6 months of C1D1
8. Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia
9. Symptomatic coronary artery disease, e.g., angina Canadian Class II-IV
10. Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions and/or known ejection fraction <40% by MUGA or <50% by echocardiogram and/or MRI
11. A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD)
12. Concomitant use of any drug known to prolong QT interval
13. Concomitant use of strong CYP3A4 inhibitors
14. Lactating, pregnant or breast feeding
15. Patients with any other medical or psychological condition deemed by the investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
16. Diagnosis of immunodeficiency or any condition that requires systemic steroid therapy or other forms of immunosuppressive therapy
17. Prior thromboembolic events
18. History of other malignancies, except:
• Malignancy treated with curative intent and with no known active disease present for = 5 years before the first dose of study drug and felt to be at low risk for recurrence by investigator.
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated carcinoma in situ without current evidence of disease
19. Any uncontrolled active systemic infection
20. Major surgery within 4 weeks of first dose of study drug
21. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk.
22. History of stroke or intracranial hemorrhage within 6 months prior to enrollment
23. History of interstitial lung disease, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis
24. Unable to swallow oral medication or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction
25. Concomitant use of warfarin or other Vitamin K antagonists
26. Known allergy or hypersensitivity to any study drug or any of the study drug excipients
27. Unwilling or unable to participate in all required study evaluations and procedures. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form and authorization to use protected health information
28. Current or prior use of immunosuppressive medication within 14 days (use 28 days if combining Durvalumab with a novel agent) before the first dose of Durvalumab
29. Active or prior documented autoimmune or inflammatory disorders
30. Any unresolved toxicity NCI CTCAE Grade = 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria .
• Patients with Grade = 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
• Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with Durvalumab may be included only after consultation with the Study Physician.
31. History of allogenic organ transplantation
32. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
33. Receipt of live attenuated vaccine within 30 days prior to the first dose of IMP
34. Subject is an employee of GWT-TUD GmbH
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Tumoren der Leber und Bauchspeicheldrüse und der Gallenwege
Medizinischer Befund
Pancreas Cancer\nPancreatic Adenocarcinoma\nPancreatic Ductal Adenocarcinoma
FASCINATION UK Jena
Frontline Asciminib combination in chronic phase CML
Arzneimittelgesetz (AMG) / Phase 2, Interventionell
prospektiv, nicht-randomisiert, Phase II, Kohortenstudie Geeignete Patienten mit de novo BCR-ABL positiver CML in chronischer Phase werden mit einem First-Line TKI nach Wahl des behandelnden Arztes anbehandelt. Dabei sind vor TKIBehandlung maximal 4 Wochen Behandlung mit Hydroxyurea erlaubt. Patienten, die für <6 Wochen mit Nilotinib 300 mg BID, Imatinib 400 mg QD oder Dasatinib 100 mg QD behandelt werden, sind…
EudraCT-Nummer: 2018-002256-33
Zurück
FASCINATION UK Jena
Studieninformationen
Studien-Code
UME-ID-8660
Studien-Akronym
FASCINATION UK Jena
Studientitel
Frontline Asciminib combination in chronic phase CML
Kurzbeschreibung
prospektiv, nicht-randomisiert, Phase II, Kohortenstudie Geeignete Patienten mit de novo BCR-ABL positiver CML in chronischer Phase werden mit einem First-Line TKI nach Wahl des behandelnden Arztes anbehandelt. Dabei sind vor TKIBehandlung maximal 4 Wochen Behandlung mit Hydroxyurea erlaubt. Patienten, die für <6 Wochen mit Nilotinib 300 mg BID, Imatinib 400 mg QD oder Dasatinib 100 mg QD behandelt werden, sind geeignet für den Studieneinschluss und werden der jeweiligen Kohorte (je maximal 30 Patienten) zugeordnet. Die Asciminib-Therapie wird 12 Wochen nach Beginn von Nilotinib, Imatinib oder Dasatinib und nach Wiederherstellung der normalen Hämatopoese begonnen. Bei Intoleranz gegenüber der TKI-Initialtherapie vor Start von Asciminib sollten Studienpatienten die TKI-Therapie wechseln. Diese Patienten werden dann jedoch nicht mit Asciminib behandelt und verbleiben nicht in der Studie. Diese Patienten werden nicht in die Zählung der Kohorten aufgenommen. Bei Wechsel des TKI unter Kombinationstherapie mit Asciminib wird die Asciminib-Therapie gestoppt und der Patient wird im Follow-Up bis zum Ende der Studie weiter beobachtet. Nach 24 Monaten Therapie werden die Patienten auf der Grundlage ihres molekularen Ansprechens in Monat 24 drei Behandlungsarmen zugeteilt. Alle Patienten setzen die aktuelle Behandlung fort, bis die zugewiesene Therapie in Monat 25 begonnen wird. 1. Patienten, die in Monat 24 keine MR4 erreicht haben, beenden Asciminib in Monat 25, verlassen die Studie und werden mit einem zugelassenen ATP-konkurrierenden TKI als Monotherapie nach dem Ermessen des Prüfarztes behandelt. Diese Patienten werden nur hinsichtlich des Überlebens weiterverfolgt. 2. Patienten mit MR4 in Monat 24 setzen die bisherige Kombinationstherapie mit dem ATPkonkurrierenden TKI und Asciminib für ein weiteres Jahr (Monat 25 bis 36) fort. 3. Bei Patienten mit MR4,5 oder besser in Monat 24 wird die Asciminib-Monotherapie mit 80 mg BID QD für ein weiteres Jahr (Monate 25 bis 36) verabreicht. Nach Monat 36 wird die Asciminib-Behandlung für alle Patienten beendet. Die weitere Behandlung hängt von der Aufrechterhaltung einer tiefen molekularen Remission (MR4 oder besser) ab: Patienten mit MR4 oder besser für mindestens ein Jahr werden die Behandlung beenden und in eine TFR-Phase eintreten. Das PCR-Follow-up wird gemäß den aktuellen Empfehlungen durchgeführt. Patienten, die eine MR4 verloren haben, werden nach Ermessen des Prüfarztes mit dem ATP-konkurrierenden TKI weiterbehandelt und nur hinsichtlich des Überlebens weiterverfolgt.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021,2023
EudraCT-Nummer: 2018-002256-33
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Joachim Göthert

+49 (0)201 723-82530
joachim.goethert@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Friedrich Schiller Universität, Jena

Studiendesign
Ausschlusskriterien
- Allogene Stammzelltransplantation
- Bekannte Beeinträchtigung der Herzfunktion, einschließlich:
o kongenitales Long-QT-Syndrom
o Vorgeschichte/Vorliegen einer signifikanten ventrikulären oder atrialen Tachyarrhythmie
o Myokardinfarkt innerhalb 12 Monate vor Therapiestart
o QTc >450 msec im Screening EKG
o Vorliegen einer klinisch signifikanten oder symptomatischen Bradykardie
o Familiengeschichte von plötzlichem idiopathischen Tod
o Patienten mit Ruhe-QTcF =450 msec (männlich) oder =460 msec (weiblich) in der Vortherapie, oder unbestimmbaren QTcF Intervall
- Patienten mit unkorrigierter Hypokaliämie oder Hypomagnesämie
- Andere klinisch signifikante Herzerkrankung (z.B. instabile Angina pectoris, Herzdekompensation, unkontrollierter Bluthochdruck).
- Akute oder chronische virale Hepatitis mit moderater oder schwerer hepatischer Beeinträchtigung (Child-Pugh scores >6), auch wenn kontrolliert
- Andere derzeitige unkontrollierte Krankheiten (z.B. aktive oder unkontrollierte Infektionen, akute oder chronische Leber- oder Nierenerkrankungen), die zu einem inakzeptablen Sicherheitsrisiko führen können oder eine prüfplankonforme Durchführung gefährden
- Beeinträchtigte Magen-Darm-Funktion oder Erkrankungen, die die Absorption der Prüfmedikation beeinträchtigen können (z. B. Geschwür, unkontrollierte Übelkeit, Erbrechen und Durchfall, Malabsorptions-Syndrom, Dünndarm-Resektion oder Magen-Bypass).
- Bekannte akute oder chronische Pankreatitis
- Einnahme von Medikamenten, die bekanntermaßen zu einer starken Induktion oder Inhibition des CYP450-Isoenzyms CYP3A4 führen.
- Patienten mit Operation = 2 Wochen vor Start der Studienmedikation, oder ausstehender Erholung von Nachwirkungen einer solchen Operation
- Schwangere, stillende oder potentiell gebärfähige Patienten ohne Nutzung effektiver Verhütungsmethoden. Potentiell gebärfähige Patienten benötigen einen negativen Serum-Schwangerschaftstest innerhalb von 14 Tagen nach Studienstart. Postmenopausale
Patienten müssen bereits für mindestens 12 Monate amenorrhoisch sein um als nicht gebärfähig zu gelten. Alle Patienten müssen einer effektiven Verhütungsmethode während, sowie mind. 2 Wochen nach Absetzen der Studienmedikation, zustimmen. Es ist nötig, dass sexuell aktive Männer beim Geschlechtsverkehr während und bis 2 Wochen nach Beendigung der Einnahme der Studienmedikation Kondome verwenden und in diesem Zeitraum kein Kind zeugen. Ein Kondom muss ebenfalls von vasektomierten Männern verwendet werden, um den Übergang des Medikaments über die Samenflüssigkeit zu verhindern. Weiblichen Partnern von männlichen Patienten wird empfohlen, hochwirksame Methoden der Empfängnisverhütung zu verwenden.)
- Bekannte Infektion mit dem humanen Immundefizienzvirus (HIV). Die Testung ist nicht verpflichtend.
- Bekannte ernsthafte Hypersensitivität gegenüber Imatinib, Nilotinib oder Dasatinib
- Patienten mit einer malignen Erkrankung, die zurzeit klinisch signifikant ist oder zurzeit eine aktive Behandlung erfordert.
- Patenten, die nicht bereit oder nicht in der Lage sind, den Anforderungen des Prüfplans Folge zu leisten.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
CML - chronische myeloische Leukämie
Medizinischer Befund
CML
MAKEI V
Multicentre prospective trial for extracranial malignant germ cell tumours including a randomized comparison of Carboplatin and Cisplatin Multizentrische prospektive Studie zu einem randomisierten Vergleich von Carboplatin mit Cisplatin bei extrakraniellen malignen Keimzelltumoren
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
Comparison of Carboplatin and Cisplatin in patients with extracranial malignant germ cell tumours
EudraCT-Nummer: 2016-001784-36
Zurück
MAKEI V
Studieninformationen
Studien-Code
UME-ID-8677
Studien-Akronym
MAKEI V
Studientitel
Multicentre prospective trial for extracranial malignant germ cell tumours including a randomized comparison of Carboplatin and Cisplatin Multizentrische prospektive Studie zu einem randomisierten Vergleich von Carboplatin mit Cisplatin bei extrakraniellen malignen Keimzelltumoren
Kurzbeschreibung
Comparison of Carboplatin and Cisplatin in patients with extracranial malignant germ cell tumours
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021,2023
EudraCT-Nummer: 2016-001784-36
Beteiligte
Institute
Klinik für Frauenheilkunde und Geburtshilfe, Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Dr. med. Stefan Schönberger

stefan.schoenberger@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Rheinische Friedrich-Wilhelms-Universität Bonn

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, National
Einschlusskriterien
- Confirmed extracranial MGCT up to 17 11/12 years of age or patients with ovarian primaries up to 29 11/12 years of age on the date of written informed consent
- Written informed consent prior to trial entry of parents and/or patient
- Diagnosis of a chemotherapy-naïve extracranial MGCT
- Karnofsky-Index of >70% or ECOG-Status 0-II
- Negative pregnancy test within 7 days prior to start of treatment for female patients of childbearing potential, in case of ß-HCG secreting MGCT pregnancy has to be excluded by appropriate methods

Note: Any patient who is of reproductive age should agree to use adequate contraception for the duration of the trial treatment and until at least 12 months after end of therapy.
Ausschlusskriterien
Exclusion criteria in general:
- Pregnancy
- Lactation
- Incomplete data at trial entry preventing risk group allocation
- HIV-positivity
- Live vaccine immunization within two weeks before start of protocol treatment
- Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of chemotherapy
- Current or recent (within 30 days prior to date of informed written consent) treatment with another investigational drug or participation in another interventional clinical trial, except trials with different end points than MAKEI V that can run in parallel to MAKEI V without influencing that trial, e.g., trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support, etc.
- Any other medical, psychiatric or drug related condition, or social condition incompatible with protocol treatment.

Exclusion criteria in special indication:
- Second malignancies
- Negative preoperative tumour markers AFP and ß-HCG and solely pure teratoma histology
- Known hypersensitivity against Cisplatin, Carboplatin, Etoposide, Ifosfamide or other ingredients of the medicinal product
- Hearing impairment Grade 3 and 4 (CTCAE Vers.4.03)
Studienteilnehmende Mindestalter
0 Tag(e)
Studienteilnehmende Höchstalter
64 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
Extracranial germ cell tumours of any malignant histology, primary site and stage
R2810-ONC-1788
A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF ADJUVANT CEMIPLIMAB VERSUS PLACEBO AFTER SURGERY AND RADIATION THERAPY IN PATIENTS WITH HIGH RISK CUTANEOUS SQUAMOUS CELL CARCINOMA
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
Study of Adjuvant Cemiplimab Versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma
EudraCT-Nummer: 2019-000566-38
Zurück
R2810-ONC-1788
Studieninformationen
Studien-Code
UME-ID-8738
Studien-Akronym
R2810-ONC-1788
Studientitel
A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF ADJUVANT CEMIPLIMAB VERSUS PLACEBO AFTER SURGERY AND RADIATION THERAPY IN PATIENTS WITH HIGH RISK CUTANEOUS SQUAMOUS CELL CARCINOMA
Kurzbeschreibung
Study of Adjuvant Cemiplimab Versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021
EudraCT-Nummer: 2019-000566-38
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Dirk Schadendorf

+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Regeneron Pharmaceuticals, Inc, USA

Studiendesign
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
Einschlusskriterien
- Men and women ≥18 years old
- For Japan only, men and women ≥21 years old
- Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease - High risk CSCC, as defined in the protocol
- Completion of curative intent post-operative radiation therapy (RT) within 2 to 6 weeks of randomization
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1
- Adequate hepatic, renal, and bone marrow function as defined in the protocol
Ausschlusskriterien
- Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
- Concurrent malignancy other than localized CSCC and/or history of malignancy other than localized CSCC within 3 years of date of randomization as defined in the protocol
- Patients with hematologic malignancies (eg, chronic lymphocytic leukemia (CLL))
- Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless the disease-free interval is at least 3 years (regional nodal involvement of disease in draining lymph node basin that was resected and radiated prior to enrollment will not be exclusionary
- Ongoing or recent (within 5 years of randomization date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
- Has had prior systemic anti-cancer immunotherapy for CSCC
Geschlecht
Männlich, Weiblich
Indikation
SCC - Plattenepithelkarzinom
Medizinischer Befund
Patients with features associated with high-risk of recurrent CSCC disease, who have completed surgery and post-operative RT radiation therapy
MedDRA Term
Squamous cell carcinoma
CABOPOINT
A PHASE II, MULTICENTRE, OPEN-LABEL STUDY OF CABOZANTINIB AS 2ND LINE TREATMENT IN SUBJECTS WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA WITH A CLEAR-CELL COMPONENT WHO PROGRESSED AFTER 1ST LINE TREATMENT WITH CHECKPOINT INHIBITORS
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
Open-Label Study of Cabozantinib as 2nd Line Treatment in Subjects with Unresectable, Locally Advanced or Metastatic Renal Cell Carcinoma with a Clear-Cell Component Who Progressed After 1st Line Treatment.
EudraCT-Nummer: 2018-002820-18
Zurück
CABOPOINT
Studieninformationen
Studien-Code
UME-ID-8767
Studien-Akronym
CABOPOINT
Studientitel
A PHASE II, MULTICENTRE, OPEN-LABEL STUDY OF CABOZANTINIB AS 2ND LINE TREATMENT IN SUBJECTS WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA WITH A CLEAR-CELL COMPONENT WHO PROGRESSED AFTER 1ST LINE TREATMENT WITH CHECKPOINT INHIBITORS
Kurzbeschreibung
Open-Label Study of Cabozantinib as 2nd Line Treatment in Subjects with Unresectable, Locally Advanced or Metastatic Renal Cell Carcinoma with a Clear-Cell Component Who Progressed After 1st Line Treatment.
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2020,2021,2022
EudraCT-Nummer: 2018-002820-18
Beteiligte
Institute
Klinik für Urologie, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Viktor Grünwald

+49 (0)201 723-3213
urologie.studien@uk-essen.de

Hufelandstr. 55
45147 Essen

Sponsor

Ipsen Pharma S.A., France

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
(1) Subjects must provide a signed informed consent prior to any study-related procedures;
(2) Male or female subjects must be aged ≥18 years on the day the informed consent is signed;
(3) Subjects must have histologically confirmed unresectable, locally advanced (defined as disease not eligible for curative surgery or radiation therapy) or metastatic RCC with a clear-cell carcinoma component;
(4) Subjects must have radiographic disease progression, according to Investigator’s judgement, following 1st line treatment with CPI (ipilimumab plus nivolumab) (Cohort A) or CPI in combination with VEGF-targeted therapy (Cohort B);
(5) Subjects present ≥1 target lesion according to RECIST 1.1 per investigator;
(6) Subjects should have Eastern Cooperative Oncology Group (ECOG) status 0-1;
(7) Subjects with treated brain metastases are eligible if metastases have been shown to be stable as per Investigator’s judgement;
(8) Subjects must have adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 15 days before baseline:
(a) Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 GI/L).
(b) Platelets ≥ 100,000/mm3 (≥ 100 GI/L).
(c) Hemoglobin ≥ 9 g/dL (≥ 90 g/L).
(d) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3.0 × upper limit of normal.
(e) Total bilirubin ≤ 1.5 × the upper limit of normal. For subjects with Gilbert’s disease ≤ 3 mg/dL (≤ 51.3 μmol/L).
(f) Fasting serum triglycerides ≤ 2.5 × upper limit of normal and total cholesterol ≤ 300 mg/dL (≤ 7.75 mmol/L). Lipid-lowering medication is allowed.
(g) Serum creatinine ≤ 2.0 × upper limit of normal or calculated creatinine clearance ≥ 30 mL/min (≥ 0.5 mL/sec) using the Cockcroft-Gault equation
(h) Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol) creatinine or 24-hour urine protein < 1 g.
(9) Subject must have recovered to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy as determined by the investigator;
(10) Subject must have completed a steroid taper if he/she experienced an immune-related adverse event associated with previous CPI treatment;
(11) Female subjects of childbearing potential (i.e. less than or equal to 2 years post-menopause and not surgically sterile) must provide a negative pregnancy test within 7 days prior to the start of study treatment. If a urine test cannot be confirmed as negative, a negative serum pregnancy test is required;
(12) Female subjects of childbearing potential (i.e. less than or equal to 2 years post-menopause and not surgically sterile) and their partners must agree to use highly effective methods of contraception that alone or in combination result in a failure rate of less than 1% per year when used consistently and correctly during the course of the study and for 120 days after the last dose of study treatment;
(13) All male participants must agree to refrain from donating sperm and unprotected sexual intercourse with female partners during the study and for 120 days after the last dose of study treatment;
(14) Subjects must be willing and able to comply with study requirements, remain at the investigational site for the required duration of each study visit and be willing to return to the investigational site for the follow up evaluation, as specified in the protocol.
(15) Subjects must be covered by social security or be the beneficiary of such a system (only applicable for French subjects).
Ausschlusskriterien
(1) Inability to swallow tablets;
(2) treated with any other investigational medicinal product (IMP) during a clinical study within the last 30 days before baseline;
(3) previously treated with cabozantinib;
(4) Has a contraindication to Magnetic Resonance Imaging (MRI) or contrast medium used for Contrast Tomography (CT)-scan;
(5) Presents untreated brain or leptomeningeal metastases, or current clinical or radiographic progression of known brain metastases;
(6) diagnosis of a serious cardiovascular disorder:
(a) Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, or serious cardiac arrhythmias;
(b) Uncontrolled hypertension, defined as sustained blood pressure (BP) (>140 mm Hg systolic or>90 mm Hg diastolic pressure) despite optimal antihypertensive treatment;
(c) Stroke (including transient ischaemic attack (TIA)), myocardial infarction (MI) or other ischaemic event, or thromboembolic event (e.g. deep venous thrombosis, pulmonary embolism) within 6 months before screening;
(d) History of risk factors for torsades de pointes (eg, long QT syndrome);
(7) receiving a concomitant anticoagulation with oral anticoagulants (e.g. warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors
Note:Low dose aspirin for cardioprotection (per local applicable guidelines) and low dose LMWH are permitted.
(8) gastrointestinal (GI) disorder including those associated with a high risk of perforation or fistula formation:
(a) Tumours invading the GI tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction;
(b) Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before screening;
Note: Complete healing of an intra-abdominal abscess must have been confirmed before screening.
(9) Presents a corrected QT (QTc) interval calculated by the Fridericia formula (QTcF)>500 msec within 1 month prior to baseline;
Note: If a single ECG shows a QTcF with an absolute value>500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility
(10) clinically significant haematuria, hematemesis, or haemoptysis of >0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding within 3 months before screening;
(11) cavitating pulmonary lesion(s) or known endobronchial disease manifestation;
(12) lesions invading major pulmonary blood vessels;
(13 ) diagnosed with other clinically significant disorders such as:
(a) Serious nonhealing wound/ulcer/bone fracture;
(b) Malabsorption syndrome;
(c) Uncompensated/symptomatic hypothyroidism (subject with a history of autoimmune-related hypothyroidism on thyroid-replacement hormone are eligible for the study)
(e) Moderate to severe hepatic impairment
(f) Requirement for haemodialysis or peritoneal dialysis
(g) History of solid organ transplantation;
(14) predicted life expectancy of less than 3 months;
(15) prior surgery within 4 weeks prior to baseline. Note: If the subject has undergone major surgery, complete wound healing must have occurred 1 month prior to baseline.
(16) palliative radiation therapy for bone within 2 weeks or for radiation fields including viscera within 4 weeks prior to baseline. Note: Resolution/healing of side effects must be complete prior to baseline;
(17) history of another active malignancy within 3 years from screening except for locally curable cancers that have been apparently cured, such as low-grade thyroid carcinoma, prostate cancer not requiring treatment , basal or squamous cell skin cancer, superficial bladder cancer, in situ melanoma, in situ prostate, cervix or breast carcinoma or other treated malignancies with <5% chance of relapse according to the Investigator;
(18) history of allergy to study treatment components or agents with a similar chemical structure or any excipient used in the formulation as listed in the SmPC document;
(19) rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption;
(20) serious medical or psychiatric condition that render the subject unable to understand the nature, scope and possible consequences of the study, and/or presents an uncooperative attitude;
(21) pregnant or breastfeeding. A ß-human chorionic gonadotrophin (HCG) serum pregnancy test will be performed up to 7 days prior to baseline for all female subjects of childbearing potential ;
(22) likely to require treatment during the study with drugs that are not permitted by the study protocol;
(23) abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject’s safety.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Indikation
Urogenitale Tumore
Medizinischer Befund
Unresectable, Locally Advanced or Metastatic Renal Cell Carcinoma with a Clear-Cell Component Who Progressed After 1st Line Treatment with Checkpoint Inhibitors
MedDRA Term
Renal cell carcinoma
ENCORAFENIB t BINIMETINIB
Encorafenib plus binimetinib in patients with locally advanced, unresectable or metastatic BRAFV600-mutated melanoma: a multi-centric, multi-national, prospective, longitudinal, non-interventional study in Germany and Austria
Berufsordnung (BO) / Nicht-interventionell
Zurück
ENCORAFENIB t BINIMETINIB
Studieninformationen
Studien-Code
UME-ID-8771
Studien-Akronym
ENCORAFENIB t BINIMETINIB
Studientitel
Encorafenib plus binimetinib in patients with locally advanced, unresectable or metastatic BRAFV600-mutated melanoma: a multi-centric, multi-national, prospective, longitudinal, non-interventional study in Germany and Austria
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021,2022
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Dirk Schadendorf

+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Alcedis GmbH, Giessen

Studiendesign
Indikation
Melanom
Medizinischer Befund
melanoma
ESPADURVA
Prospective Phase-II Trial of induction chemotherapy and chemoradiotherapy plus/minus the PD-L1 antibody durvalumab followed by surgery or definitive chemoradiation boost and consolidation durvalumab in resectable stage III NSCLC
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
Comparison of two treatment arms of patients with non-small cell lung cancer. Patients of one arm receive the authorized infusion Durvalumab after chemotherapy, chemotherapy with radiotherapy and optional resection. Patients in the second treatment arm receive Durvalumab from the beginning, in parallel with standard therapy.
EudraCT-Nummer: 2019-000058-77
Zurück
ESPADURVA
Studieninformationen
Studien-Code
UME-ID-8773
Studien-Akronym
ESPADURVA
Studientitel
Prospective Phase-II Trial of induction chemotherapy and chemoradiotherapy plus/minus the PD-L1 antibody durvalumab followed by surgery or definitive chemoradiation boost and consolidation durvalumab in resectable stage III NSCLC
Kurzbeschreibung
Comparison of two treatment arms of patients with non-small cell lung cancer. Patients of one arm receive the authorized infusion Durvalumab after chemotherapy, chemotherapy with radiotherapy and optional resection. Patients in the second treatment arm receive Durvalumab from the beginning, in parallel with standard therapy.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2019,2020,2021,2022,2023,2024
EudraCT-Nummer: 2019-000058-77
Beteiligte
Institute
Klinik und Poliklinik für Strahlentherapie, Innere Klinik (Tumorforschung), Ruhrlandklinik - Thorakale Onkologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Wilfried Eberhardt

wilfried.eberhardt@uk-essen.de

Hufelandstr. 55
45147 Essen

Sponsor

Universitätsklinik Essen (AöR)

+49 (0)201 723-0
info@uk-essen.de

Hufelandstraße 55
45147 Essen

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, National
Einschlusskriterien
1. Body weight >30 kg
2. Age = 18 years and < 75 years
3. Male or female patients. Female (as well as male) patients have to take care of effective measures of anticonception
4. Histologically proven non-small cell lung cancer
5. Selected patients with non-small cell lung cancer stages IIIA and IIIB:
• IIIA: one or more lymph node levels involved at EBUS/mediastinoscopy
• IIIA: bulky N2-disease histologically proven at EBUS/cervical mediastinoscopy / parasternal mediastinotomy, not diffuse mediastinal involvement
• selected IIIB: N3-disease with contralateral mediastinal nodes involved at EBUS / mediastinoscopy
• potentially resectable T4-disease:
o involvement of the pulmonary artery (angiogr.-CT/MRI/TEE),
o involvement of the carina (histologically proven),
o involvement of the left atrium (angiogr.-CT/MRI/TEE),
o involvement of the vena cava (angiogr.-CT/MRI/TEE),
o involvement of ipsilateral intrapulmonary satellite nodules,
o mediastinal involvement (not diffuse)
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Resectable disease at the time of inclusion
8. Fulfillment of adequate criteria for functional and medical resectability as described in the ERS/ESTS guidelines [Brunelli et al 2009] and acceptable general clinical condition for multimodality treatment (interdisciplinary committee)
9. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
10. Must have a life expectancy of > 12 weeks
11. Adequate normal organ and marrow function as defined below:
o Haemoglobin = 9.0 g/dL
o Absolute neutrophil count (ANC) > 1.5 x 109/L (> 1500 per mm3)
o Platelet count = 100 x 109/L (= 100.000 per mm3)
o Serum bilirubin = 1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
o AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper limit of normal
o Measured creatinine clearance (CL) > 40 mL/min or Calculated creatinine CL > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
12. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause
13. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
14. Stable cardiac function (no Myocardial infarction (MI) within 6 months, no heart failure NYHA III-IV)
Ausschlusskriterien
1. resectable IIB or selected IIIA
2. unresectable disease pre-treatment
3. mixed histology with areas of small cell carcinoma
4. clinically symptomatic vena cava superior syndrome
5. diffuse mediastinal involvement
6. patients with T3N3 and T4N3 tumors
7. invasion of the thoracic aorta
8. invasion of the heart
9. invasion of the esophagus
10. invasion of spine
11. Pancoast-syndrome in tumors of the superior sulcus
12. malignant pericardial effusion
13. malignant pleural effusion
14. involvement of the contralateral hilar nodes
15. endobronchial tumor extension to the contralateral main stem bronchus
16. ipsi- or contralateral supraclavicular nodes
17. lung or heart function not allowing at the time of inclusion the intended surgical procedure
18. previous administration of chemotherapy and/or radiotherapy
19. previous immunotherapy
20. insufficient patients compliance
21. loss of weight > 10 % in the last six months
22. missing written informed consent or definitive refusal for participation
23. Participation in another clinical study with an investigational product during the last 12 months
24. Concurrent enrolment in another clinical study, unless it is an observational clinical study or during the follow-up period of an interventional study
25. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day
26. History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan
27. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions is acceptable
28. Major surgical procedure within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable
29. History of allogenic organ transplantation
30. History of a stem cell transplantation
31. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]).
32. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
33. History of another primary malignancy
34. History of active primary immunodeficiency
35. Active infection including tuberculosis hepatitis B, hepatitis C, or human immunodeficiency virus. Patients with a past or resolved HBV infection are eligible. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for HCV RNA
36. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
37. Current or prior use of immunostimulatory agents within 14 days before the first dose of durvalumab
38. Receipt of live attenuated vaccine within 90 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90 days after the last dose of IP
39. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy
40. Known allergy or hypersensitivity to durvalumab or any excipientFor full text exclusion criteria and exceptions please refer to study protocol section 4.2
Studienteilnehmende Mindestalter
18 Jahr(e)
Studienteilnehmende Höchstalter
74 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Lungenkrebs
Medizinischer Befund
non-small cell lung cancer stages IIIA (N2) and selected resectable stages IIIB
MedDRA Term
Non-small cell lung cancer
ML-DS 2018
Phase III Clinical Trial for CPX-351 in Myeloid Leukemia in Children with Down Syndrome 2018
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
Clinical Trial for the Treatment of Myeloid Leukemia in Children with Down Syndrome
EudraCT-Nummer: 2018-002988-25
Zurück
ML-DS 2018
Studieninformationen
Studien-Code
UME-ID-8813
Studien-Akronym
ML-DS 2018
Studientitel
Phase III Clinical Trial for CPX-351 in Myeloid Leukemia in Children with Down Syndrome 2018
Kurzbeschreibung
Clinical Trial for the Treatment of Myeloid Leukemia in Children with Down Syndrome
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022
EudraCT-Nummer: 2018-002988-25
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Dirk Reinhardt

+49 (0)201 723-3784
dirk.reinhardt@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

German Pediatric Oncology Group, GPOH gGmbH, Berlin

Studiendesign
nicht-randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
• Myeloid Leukemia (ML) or Myelodysplastic Syndrome (MDS), according to WHO
• Trisomy 21: Down syndrome or mosaic
• Age: > 6 months and = 4 years of age with/without GATA1 mutation OR > 4 years of age < 6 years of age with GATA1 mutation
• Morphology/Immunophenotyping: FAB M0, M6 or M7
• Lansky performance score at least equal to 50; or Karnofsky performance status at least equal to 50, whichever is applicable
• Understand and voluntarily provide written permission of parental/legal representative(s) to the ICF prior to conducting any study related assessments/procedures, also concerning data and tumor material transfer according to ICH/GCP and national/local regulations
• Able to adhere to the study visit schedule and other protocol requirements
Ausschlusskriterien
• Children with Transient Abnormal Myelopoiesis (TAM), according to WHO
• Cytogenetics: AML with recurrent genetic abnormalities (WHO 2016)
• Previous allogeneic bone marrow, stem cell or organ transplantation
• Evidence of invasive fungal infection or other severe systemic infection requiring treatment doses of systemic/parenteral therapy including known active viral infection with human immunodeficiency virus (HIV) or Hepatitis Type B and C
• Symptomatic cardiac disorders (CTCAE 4.0 Grade 3 or 4)Major surgery within 21 days of the first dose.
• Any anti-cancer therapy (e.g., intensive chemotherapy, biologics or radiotherapy) for more than 14 days or within 4 weeks before start of therapy, except low-dose cytarabine for the treatment of TAM.
• Concomitant treatment with any other anticancer therapy except those specified in protocol during the study therapy
• Treated by any investigational agent in a clinical study within previous 4 weeks
• History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
• Former Enrolment to this study
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
Myeloid Leukemia in Children with Down Syndrome
NEOpredict-Lung
Neoadjuvant nivolumab combination treatment in resectable non-small cell lung cancer patients: Defining optimal combinations and determinants of immunological response (NEOpredict-Lung)
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
NEOpredict-Lung is a clinical study in subjects with histologically or cytologically confirmed, early stage or locally advanced non-small cell lung cancer (NSCLC) eligible for curative resection. This study will determine the feasibility of two cycles of preoperative immunotherapy with nivolumab or as combination nivolumab plus relatlimab.
EudraCT-Nummer: 2019-002478-29
Zurück
NEOpredict-Lung
Studieninformationen
Studien-Code
UME-ID-8828
Studien-Akronym
NEOpredict-Lung
Studientitel
Neoadjuvant nivolumab combination treatment in resectable non-small cell lung cancer patients: Defining optimal combinations and determinants of immunological response (NEOpredict-Lung)
Kurzbeschreibung
NEOpredict-Lung is a clinical study in subjects with histologically or cytologically confirmed, early stage or locally advanced non-small cell lung cancer (NSCLC) eligible for curative resection. This study will determine the feasibility of two cycles of preoperative immunotherapy with nivolumab or as combination nivolumab plus relatlimab.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021,2022,2023,2024
EudraCT-Nummer: 2019-002478-29
Beteiligte
Institute
Innere Klinik (Tumorforschung), Ruhrlandklinik - Klinik für Thoraxchirurgie und thorakale Endoskopie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Schuler

martin.schuler@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Universitätsklinik Essen (AöR)

+49 (0)201 723-0
info@uk-essen.de

Hufelandstraße 55
45147 Essen

Studiendesign
randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
1. Patients with histologically or cytologically (EBUS-TBNA) confirmed non-small cell lung cancer (NSCLC) eligible for anatomic resection, with the following specification:
• Clinical stages I A3, I B, II and selected stage III A (T3 N1, T4 with satellite nodule in the same lung N0/N1, selected T1a-T2b N2 cases considered suitable for primary surgical approach by the multidisciplinary tumor board) according to UICC 8th edition.
• Female and male patients >= 18 years.
Patients in reproductive age must be willing to use adequate contraception during the study and for 6 months after the end of treatment. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test
2. ECOG ≤ 1
3. Exclusion of extensive mediastinal lymph node metastases (multilevel N2, N3) by PET/CT and/or mediastinal lymph node sampling by EBUS/TBNA and/or staging mediastinoscopy.
4. Exclusion of distant metastases by standard of care imaging studies, which include but are not limited to PET/CT or PET/MRI, or CT or MRI of thorax, abdomen, pelvis, and bone scan. Asymptomatic brain metastases will be excluded by MRI or contrast-enhanced CT as indicated by current guidelines.
5. Measurable target tumor prior to immunotherapy using standard imaging techniques.
6. Sufficient pulmonary function to undergo curative lung cancer surgery, ppFEV1>30%, ppDLCO>30%, ppVO2max>=10 ml/min/kg (if CPET was mandated per local guidelines)
7. Adequate hematological, hepatic and renal function parameters:
o Leukocytes ≥ 2,000/mm³, platelets ≥ 100,000/mm³, absolute neutrophil count (ANC) ≥ 1,500/µL, hemoglobin ≥ 9 g/dL (5.58 mmol/L),
o Anti-platelet therapy (such as but not limited to clopidogrel) should be discontinued pre-operative according to local standards. If this therapy cannot but interrupted due to severe cardiovascular comorbidity, patient is ineligible for trial
o Adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the upper limit of normal (ULN) (unless receiving anticoagulation therapy). Patients receiving warfarin/phenprocoumon or direct oral anticoagulants are to be bridged according to local standards and have achieved stable coagulation profile prior to surgery.
o Serum creatinine ≤ 1.5 x upper limit of normal
o Bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.0 x upper limit of normal, alkaline phosphatase ≤ 6 x upper limit of normal
8. Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
Ausschlusskriterien
1. Active or history of autoimmune disease or immune deficiency,
* Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study.
* Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
* skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic immunosuppressive treatment, in particular corticosteroids are permitted to enroll
2. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
3. Subjects who have undergone organ transplant or allogeneic stem cell transplantation.
4. FEV<30%, DLCO<30%, ppO2 < 10 ml/min/kg
5. Uncontrolled or significant cardiovascular disease
• History of other clinically significant cardiovascular disease
• Cardiovascular disease-related requirement for daily supplemental oxygen
• History of two or more MIs OR two or more coronary revascularization procedures
• Subjects with history of myocarditis, regardless of etiology
• Troponin T (TnT) or I (TnI) > 2 × institutional ULN
6. Active malignancy or a prior malignancy within the past 3 years
• Patients with completely resected basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in-situ, breast carcinoma in-situ, and patients with isolated elevation in prostate-specific antigen or low risk prostate cancer managed with active surveillance or watchful waiting in the absence of radiographic evidence of metastatic prostate cancer are eligible for the study.
7. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). NOTE: Testing for HIV must be performed at sites where mandated locally.
8. Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., hepatitis B surface antigen (HBsAg, Australia antigen) positive, or hepatitis C antibody (anti-HCV) positive (except if HCV RNA negative).
9. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
10. Peripheral polyneuropathy NCI CTCAE Grade = 2
11. History of gastric perforation or fistulae in past 6 months
12. Serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment.
13. The patient has undergone major surgery within 28 days prior to enrollment except staging mediastinoscopy, diagnostic VATS or implantation of a venous port-system.
14. Any other concurrent antineoplastic treatment including irradiation
15. Breastfeeding women
16. Women of childbearing potential unless women who meet the following criteria:
* Post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH > 40 U/mL)
* Postoperatively (six weeks after bilateral ovariectomy with or without hysterectomy)
* Regular and correct use of a contraceptive method with error rate <1% per year such as implants, depot injections, oral contraceptives or intrauterine devices during the treatment and at least up to 5 months after last treatment
* Sexual abstinence during the treatment and at least up to 5 months after last treatment
* Vasectomy of the partner
17. Men of sexual activity with women of childbearing potential who are not willing to use an effective barrier method of contraception during and up to 7 months after the end of therapy
18. A confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
a. Subjects with history of life-threatening toxicity related to prior immune therapy (eg. anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy.
b. Prior treatment with LAG-3 targeted agent.
Other
• Participation in another interventional clinical study within the last 3 months prior to inclusion or simultaneous participation in other clinical studies
• Previous treatment with nivolumab or relatlimab
• Previous immunotherapy for lung cancer
• Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject’s safety
• Any contraindications against nivolumab or relatlimab
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Lungenkrebs
Medizinischer Befund
non-small cell lung cancer (NSCLC) of clinical stages I A3, II and selected stage III A
MedDRA Term
Non-small cell lung cancer
EMQoLI
Entwicklung und Validierung des Essen Melanoma Quality of Life Inventory
Berufsordnung (BO) / Nicht-interventionell
Zurück
EMQoLI
Studieninformationen
Studien-Code
UME-ID-8862
Studien-Akronym
EMQoLI
Studientitel
Entwicklung und Validierung des Essen Melanoma Quality of Life Inventory
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2022
Beteiligte
Institute
LVR Kliniken-Essen - Klinik für Psychosomatische Medizin und Psychotherapie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Frau Venja Musche

+49 (0)201 438 755-227
Venja.musche@lvr.de

Virchowstr 174
45147 Essen

Studiendesign
Geschlecht
Männlich, Weiblich
Indikation
Melanom
Medizinischer Befund
malignes Melanom
2215-CL-0603
A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
A study of Gilteritinib combined with chemotherapy to treat Children, Adolescents and Young Adults with Relapsed or Refractory Acute Myeloid Leukemia (AML) with a FLT3 gene mutation.
EudraCT-Nummer: 2018-002301-61
Zurück
2215-CL-0603
Studieninformationen
Studien-Code
UME-ID-8877
Studien-Akronym
2215-CL-0603
Studientitel
A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Kurzbeschreibung
A study of Gilteritinib combined with chemotherapy to treat Children, Adolescents and Young Adults with Relapsed or Refractory Acute Myeloid Leukemia (AML) with a FLT3 gene mutation.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021
EudraCT-Nummer: 2018-002301-61
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Dirk Reinhardt

+49 (0)201 723-3784
dirk.reinhardt@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Astellas Pharma Global Development, Inc., USA

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent and privacy language as required per national regulations (e.g., Health InsurancePortability and Accountability Act Authorization for US sites) must be obtained from the subject or subject’s parent or legal guardian and if required child assent prior to any study-relatedprocedures (including withdrawal of prohibited medication, if applicable).2. Subject is positive for the FLT3/ITD mutation in bone marrow or blood as determined by the local institution.3. Subject is aged = 6 months and < 21 years of age at the time of signing informed consent and/or assent, as applicable.4. Subject has a diagnosis of AML according to The French–American–British (FAB) classification with = 5% blasts in the bone marrow, with or without extramedullary disease (except subjectswith active central nervous system [CNS] leukemia).5. Subject has Karnofsky score = 50 (if the subject is of = 16 years of age) or Lansky score of = 50 (if the subject is < 16 years of age).
Ausschlusskriterien
1. Subject has active CNS leukemia.2. Subject has uncontrolled or significant cardiovascular disease3. Subject has systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The subject needs to be off pressors and have negative blood cultures for 48 hours.5. Subject is receiving or plans to receive concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.6. Subject has active clinically significant GVHD or is on treatment with systemic corticosteroids and is receiving > 0.5 mg/kg of prednisone (or equivalent) daily dose for GVHD.7. Subject has active malignant tumors other than AML.8. Subject has hypokalemia and/or hypomagnesemia at Screening (defined as values below institutional lower limit of normal [LLN]). Repletion of potassium and magnesium levels during the screening period is allowed.9. Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A.10. Subject must wait for at least 5 half-lives after stopping therapy with any investigational agent and before starting gilteritinib.
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
FMS-like Tyrosine Kinase 3 (FLT3)\/Internal Tandem Duplication (ITD) Positive Relapsed orRefractory Acute Myeloid Leukemia (AML)
MedDRA Term
Acute myeloid leukemia
CPDR001X2X01B
An open-label, multi-center rollover protocol for continued characterization of safety and tolerability for subjects who have participated in a Novartis­sponsored spartalizumab study as single agent or in combination with other study treatments
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
Zurück
CPDR001X2X01B
Studieninformationen
Studien-Code
UME-ID-8943
Studien-Akronym
CPDR001X2X01B
Studientitel
An open-label, multi-center rollover protocol for continued characterization of safety and tolerability for subjects who have participated in a Novartis­sponsored spartalizumab study as single agent or in combination with other study treatments
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2023
Beteiligte
Institute
Klinik für Endokrinologie, Diabetologie und Stoffwechsel, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Dr. med. Harald Lahner

harald.lahner@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Novartis Pharma Schweiz AG

+41 41 763 71 11

Suurstoffi 14
6343 Rotkreuz

Studiendesign
nicht-randomisiert, offen, Multizentrisch, International
Einschlusskriterien
- Subject is currently enrolled in a pre-defined Novartis-sponsored study and is receiving spartalizumab as single agent or in combination with other study treatment,
- Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator.
Other protocol defined inclusion criteria may apply
Ausschlusskriterien
- Subject has been permanently discontinued from spartalizumab in the parent protocol for any reason other than enrollment in the Roll over Study
- Subject does not meet the criteria specified in the parent protocol criteria for continued study treatment.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Phase I Studie
Medizinischer Befund
Advanced Solid Tumors
PALOMA
Primary comparison of Liposomal Anthracycline based treatment versus conventional care strategies before allogeneic stem cell transplantation in patients with higher risk MDS and oligoblastic AML
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
Primary comparison of therapies before stem cell transplantation in patients with higher risk MDS and oligoblastic AML
EudraCT-Nummer: 2018-002430-21
Zurück
PALOMA
Studieninformationen
Studien-Code
UME-ID-9015
Studien-Akronym
PALOMA
Studientitel
Primary comparison of Liposomal Anthracycline based treatment versus conventional care strategies before allogeneic stem cell transplantation in patients with higher risk MDS and oligoblastic AML
Kurzbeschreibung
Primary comparison of therapies before stem cell transplantation in patients with higher risk MDS and oligoblastic AML
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021,2024
EudraCT-Nummer: 2018-002430-21
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Maher Hanoun

+49 (0)201 723-82530
maher.hanoun@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

GWT-TUD GmbH, Dresden

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, National
Einschlusskriterien
1. Adult patients, 18-75 years of age
2. Diagnosis of high risk MDS including oligoblastic non-proliferative (WBC <13 Gpt/l) AML up to 29% of bone marrow blasts
3. Bone marrow blasts = 5% (central morphology Düsseldorf)
4. IPSS score intermediate-2 or high
5. alloHCT intended within the next 6 months
6. ECOG performance status of 0 or 1
7. Signed informed consent
8. Laboratory values fulfilling all of the following:
- Serum creatinine < 2.0 mg/dL- Serum total bilirubin < 2.0 mg/dL
- Serum alanine aminotransferase or aspartate aminotransferase < 3 times the ULN9. Cardiac ejection fraction (LVEF) = 50% by echocardiography
10. Contraception:
- Female subjects of childbearing potential† must agree to use a medically acceptable method of contraception from signature of ICF (for at least 1 months prior to the first dose of CPX-351) and consent of female patients to use a medically acceptable method of contraception throughout the entire study period and for 6 months following the last dose of CPX-351. Medically acceptable methods of contraception that may be used by the patient include diaphragm and spermicide, intrauterine device (IUD), condom and vaginal spermicide, hormonal contraceptives (patients must be stable on hormonal contraceptives for at least the prior 3 months), surgical sterilization, or post-menopausal (=2 years of amenorrhea). Medically acceptable methods of contraception that may be used by the male partner of a female patient are condom and spermicide or vasectomy (>6 months prior to Day-1) and are to be used throughout the entire study period and for 6 months following the last dose of CPX-351.
- Male patients must be willing to refrain from sperm donation for 6 months following the last dose of CPX-351 and must use adequate contraception throughout the entire study period and for 6 months following the last dose of CPX-351.
- Combined oral contraceptive pills are not recommended. It is recommended that during the study two medically accepted methods of contraception (e.g. as hormonal contraceptive methods along with a condom) apply.

†A female subject or a female partner of a male subject is considered to have childbearing potential unless she meets at least one of the following criteria: Age =50 years and naturally amenorrhoeic for = 1 year (amenorrhoea following cancer therapy does not rule out childbearing potential), premature ovarian failure confirmed by a specialist gynecologist, previous bilateral salpingo-oophorectomy or hysterectomy, XY genotype, Turner syndrome or uterine agenesis.
Ausschlusskriterien
1. Patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.
2. WHO-2016 defined AML entities: AML with t(15;17), PML-RARA; AML with t(8;21), RUNX1-RUNX1T1, AML with inv(16)/t(16;16), CBFß-MYH11; AML with biallelic CEBPA mutation; AML with mutated FLT3 or NPM1.
3. Clinical evidence of active CNS leukaemia (assessment of CSF is not mandatory for screening).
4. Patients with a “currently active” second malignancy other than non-melanoma skin cancers. Patients are not considered to have a “currently active” malignancy if they have completed therapy more than 2 years ago and are disease free.
5. Any major surgery or radiation therapy within four weeks prior screening.
6. Patients with prior treatment of either CPX-351, hypomethylating agents, cytarabine or intensive chemotherapy for high-risk MDS or AML.
7. Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent).
8. Recent (<30 days) or planned live vaccinations during the clinical trial
9. Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent.
10. Creatinine clearance < 30 ml/min
11. Active or uncontrolled infection. Patients with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for =72 hrs.
12. Current evidence of invasive fungal infection (blood or tissue culture); patients with recent fungal infection must have a subsequent negative cultures to be eligible; known HIV (new testing not required) or evidence of active hepatitis B or C infection (with rising transaminase values).
13. Hypersensitivity to cytarabine, daunorubicin or liposomal products.
14. History of Wilson’s disease or other copper-metabolism disorder, unless the therapy outweighs the risks.15. Female patients who are pregnant or lactating.
Studienteilnehmende Mindestalter
18 Jahr(e)
Studienteilnehmende Höchstalter
75 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
MDS - Myelodysplastisches Syndrom, AML - Akute myeloische Leukämie
Medizinischer Befund
Untreated patients with higher risk MDS and oligoblastic AML eligible and intended for allogeneic HCT within the next 6 months
MedDRA Term
Acute myeloid leukemia, Myelodysplastic syndromes
PeRiOperative Treatment with Erleada United with Surgery (PROTEUS)
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
A study of androgen deprivation therapy (ADT) plus apalutamide (with or without abiraterone acetate with prednisone/prednisolone [AAP]) in patients with prostate cancer
EudraCT-Nummer: 2018-001746-34
Zurück
PeRiOperative Treatment with Erleada United with Surgery (PROTEUS)
Studieninformationen
Studien-Code
UME-ID-9029
Studien-Akronym
PeRiOperative Treatment with Erleada United with Surgery (PROTEUS)
Studientitel
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy
Kurzbeschreibung
A study of androgen deprivation therapy (ADT) plus apalutamide (with or without abiraterone acetate with prednisone/prednisolone [AAP]) in patients with prostate cancer
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021
EudraCT-Nummer: 2018-001746-34
Beteiligte
Institute
Klinik für Urologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Claudia Kesch

+49 (0)201 723-3213
urologie.studien@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Janssen-Cilag International NV (BE)

Studiendesign
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
Einschlusskriterien
1. Must be ≥18 years of age
2. Signed an informed consent form (ICF) indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study; subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol (Section 4.3)
3. Histologically confirmed adenocarcinoma of the prostate
4. Criterion modified per Amendment 1
4.1. Criterion modified per Amendment 2
4.2 High risk disease defined by a total Gleason Sum Score ≥4+3 (=Grade Groups [GG] 3 5) and ≥1 of the following 4 criteria:
• Any combination of Gleason Score 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in ≥6 systematic cores (with ≥1 core Gleason Score 8 [4+4 or 5+3] included);
• Any combination of Gleason Score 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in ≥3 systematic cores and PSA ≥20 ng/mL (with ≥1 core Gleason Score 8 [4+4 or 5+3] included);
• Gleason Score ≥9 (=GG 5) in at least 1 systematic or targeted core; or
• At least 2 systematic or targeted cores with continuous Gleason Score ≥8 (=GG 4), each with ≥80% involvement
5. Criterion modified per Amendment 1
5.1. Candidate for RP with pLND as per the investigator
6. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
7. Criterion modified per Amendment 1
7.1. Criterion modified per Amendment 2
7.2. Adequate organ function determined by the following central laboratory values:
a. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin within normal limits, ie, ≤ the upper limit of normal ([ULN]; note that in subjects with Gilbert's syndrome, if total bilirubin is >1.5 X ULN, measure direct and indirect bilirubin. If direct bilirubin is ≤ 1.5 X ULN, the subject may be eligible);
b. Serum creatinine <1.8 mg/dL;
c. Platelets ≥75,000/microliter, without transfusion and/or growth factors within 1 month prior to randomization;
d. Hemoglobin ≥12.0 g/dL (7.4 mmol), without transfusion and/or growth factors within 1 month prior to randomization
8. Criterion modified per Amendment 4
8.1. Able to receive ADT for at least 13 months, based on cardiovascular risk assessment and the investigator's assessment
9. Criterion modified per Amendment 1
9.1. Be able to swallow whole study drug tablets
10. Criterion modified per Amendment 1
10.1. Criterion modified per Amendment 2
10.2. Criterion modified per Amendment 7
10.3. Contraceptive use by male subjects (and female partners of male subjects enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the use of contraceptive methods for subjects participating in clinical studies.
Ausschlusskriterien
1. Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Patients are considered eligible only if the central radiological review confirms clinical stage M0
2. Criterion modified per Amendment 2
2.1. (a) Prior treatment with androgen receptor antagonists.
(b) Treatment with GnRHa analogs prior to ICF signature.
3. Criterion deleted per Amendment 1
4. Criterion deleted per Amendment 1
5. Bilateral orchiectomy
6. Criterion modified per Amendment 1
6.1. Criterion modified per Amendment 2
6.2. History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
7. Criterion modified per Amendment 1
7.1. Use of any investigational agent =4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time
8. Major surgery =4 weeks prior to randomization
9. Criterion modified per Amendment 4
9.1. Any of the following within 12 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
10. Human immunodeficiency virus-positive subjects with 1 or more of the following:
a. Not receiving highly active antiretroviral therapy
b. Had a change in antiretroviral therapy within 6 months of the start of screening
c. Receiving antiretroviral therapy that may interfere with study drug (consult sponsor for review of medication prior to enrollment)
d. CD4 count <350 at screening
e. AIDS-defining opportunistic infection within 6 months of start of screening
11. Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction
12. Criterion modified per Amendment 2
12.1. History of seizure; any condition that may predispose to seizure (including, but not limited to, prior stroke, transient ischemic attack, or loss of consciousness =1 year prior to randomization); presence of brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect
13. Treatment with drugs known to lower the seizure threshold within 4 weeks prior to randomization
14. Gastrointestinal conditions affecting absorption
15. Criterion modified per Amendment 1
15.1. Known or suspected contraindications or hypersensitivity to apalutamide, GnRHa analogues or any of the components of the formulations
16. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject
17. Criterion modified per Amendment 2
17.1. Active malignancies (ie, progressing or requiring treatment or treatment change in the last 24 months) other than prostate cancer. The only allowed exceptions are: non-muscle invasive bladder cancer (NMIBC); skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured; breast cancer (adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence); malignancy that is considered cured with minimal risk of recurrence.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich
Indikation
Urogenitale Tumore
Medizinischer Befund
High-risk localized or locally advanced prostate cancer
MedDRA Term
Prostate cancer
AIO-HEP-0418-DEMAND
Randomisierte, zweiarmige, nicht vergleichende Phase II Studie zur Wirksamkeit von Atezolizumab und Roche Bevacizumab (Atezo/Bev) gefolgt von selektiver TACE nur bei Bedarf (sdTACE) im Falle des Auftretens von Krankheitsprogression oder initial synchroner Behandlung mit TACE und Atezo/Bev auf die 24-Monate-Überlebensrate bei der Behandlung von Patienten mit nicht resektablem hepatozellulärem Karzinom (DEMAND)
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
Untersuchung der Wirksamkeit von Atezolizumab plus Bevacizumab gefolgt von einer selektiven TACE bei Bedarf oder einer Initial synchronen Behandlung mit TACE und Atezolizumab/Bevacizumab bei nicht resektablem hepatozellulärem Karzinom
EudraCT-Nummer: 2019-002430-36
Zurück
AIO-HEP-0418-DEMAND
Studieninformationen
Studien-Code
UME-ID-9051
Studien-Akronym
AIO-HEP-0418-DEMAND
Studientitel
Randomisierte, zweiarmige, nicht vergleichende Phase II Studie zur Wirksamkeit von Atezolizumab und Roche Bevacizumab (Atezo/Bev) gefolgt von selektiver TACE nur bei Bedarf (sdTACE) im Falle des Auftretens von Krankheitsprogression oder initial synchroner Behandlung mit TACE und Atezo/Bev auf die 24-Monate-Überlebensrate bei der Behandlung von Patienten mit nicht resektablem hepatozellulärem Karzinom (DEMAND)
Kurzbeschreibung
Untersuchung der Wirksamkeit von Atezolizumab plus Bevacizumab gefolgt von einer selektiven TACE bei Bedarf oder einer Initial synchronen Behandlung mit TACE und Atezolizumab/Bevacizumab bei nicht resektablem hepatozellulärem Karzinom
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022
EudraCT-Nummer: 2019-002430-36
Beteiligte
Institute
Klinik für Gastroenterologie und Hepatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Hartmut Schmidt

+49 (0)201 723-3610
hartmut.schmidt@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Universitätsklinikum der Ludwig-Maximilians-Universität München

Studiendesign
randomisiert, offen, nicht-kontrolliert, Multizentrisch, National
Einschlusskriterien
1. Vom Patienten unterschriebene Einverständniserklärung zur Studienteilnahme
2. Alter ≥ 18 Jahre bei Unterzeichnung der Einverständniserklärung
3. Nach Einschätzung des Prüfarztes geeignet zur Erfüllung der Anforderungen des Studienprotokolls
4. Lebenserwartung von ≥ 12 Wochen
5. HCC (histologisch bestätigte Diagnose)
6. Krankheit, die einer kurativen Behandlung mit Chirurg. Maßnahmen/ lokalen Ablation nach Konsens eines multidisziplinären lokalen Tumorboards nicht zugänglich ist, jedoch für TACE auswählbar ist, mit einer Tumorlast < 50% des Lebervol.
7. Mind. eine nach RECIST 1.1 messbare, unbehandelte Läsion
8. ECOG 0 oder 1
9. Child-Pugh Klasse A oder B7
10. Adäquate hämat. Funktion und Endorganfunktion, innerhalb von 14 Tagen (sofern nicht anders spezifiziert) vor Random. definiert durch:
- neut. Granulozyten ≥1,5 x 109/L (1500/μL) ohne Granulozyten-Kolonie stimulierende Faktoren
- Lymphozyten ≥ 0,5 x 109/L (500/μL)
- Thrombozyten ≥ 75 x109/L (75,000/μL) ohne Transfusion
- Hämoglobin ≥ 90 g/L (9 g/dL); Patienten transfundiert worden sein
- AST, ALT, und AP ≤ 5 x ULN
- Bilirubin im Serum ≤ 3 x ULN
- Kreatinin im Serum ≤ 1,5 x ULN oder Kreatinin Clearance ≥ 50 mL/min
(Cockcroft-Gault Formel)
- Albumin im Serum ≥ 28 g/L (2,8 g/dL)
- Bei Patienten, die keine therapeutische Antikoagulation erhalten: INR <1,25
- Urinuntersuchung mit Teststreifen auf Proteinurie < 2+ (innerhalb von 14 Tagen vor Start), es sei denn, eine nachfolgende Untersuchung im 24 Stunden Sammelurin weist < 1g Protein nach
11. Negativer HIV Test beim Screening
12. Dokumentierter virologischer Status im Hinblick auf Hepatitis, bestätigt durch serologische Testung auf HBV und HCV beim Screening. Bei Patienten mit aktiver Hepatitis B Virus –Infektion: HBV DNS < 500 IU/mL innerhalb von 28 Tagen vor Randomisierung, und Anti-HBV Behandlung nach lokalem Behandlungsstandard für mindestens 14 Tage vor Randomisierung sowie Bereitschaft, diese für die Dauer der Studie fortzufahren.
13. Bei gebärfähigen Frauen: negativer Schwangerschaftstest innerhalb von 14 Tagen vor Randomisierung und Bereitschaft, entweder vollständig enthaltsam zu bleiben (vollständige Enthaltsamkeit von heterosexuellem Geschlechtsverkehr) oder empfängnisverhütende Mittel mit einer Versagensquote unter 1% pro Jahr während der gesamten Dauer der Behandlung sowie für mindestens 5 Monate nach letzter Gabe von Atezolizumab und 6 Monate nach letzter Gabe von Bevacizumab zu
benutzen.
Eine Frau wird als gebärfähig eingeschätzt, wenn sie die Menarche hatte, nicht einen postmenopausalen Status erreicht hat (≥ 12 Monate Amenorrhoe ohne einen anderen identifizierten Grund als die Menopause) und nicht einer chirurgischen Sterilisation (Entfernung der Eierstöcke und/oder des Uterus) unterzogen wurde. Beispiele für Methoden zur Empfängnisverhütung mit einer Versagensquote <1% pro Jahr sind die beidseitige Tubenligatur, die Sterilisation des männlichen Partner, hormonale Kontrazeptiva, die die Ovulation verhindern, Hormonspiralen und Kupferspiralen. Die Verlässlichkeit der sexuellen Enthaltsamkeit sollte in Bezug auf die Dauer der klinischen Prüfung und den bevorzugten und gewöhnlichen Lebensstil des Patienten beurteilt werden. Periodische Abstinenz (z.B. nach der Kalendermethode oder um den Zeitpunkt des Eisprungs, symptothermale Methoden oder periodische sexuelle Enthaltsamkeit von der Menstruation bis nach erfolgtem Eisprung) und Coitus interruptus
sind keine akzeptierten Methoden zur Empfängnisverhütung.
14. Für Männer: Bereitschaft, entweder vollständig enthaltsam zu bleiben (vollständige Enthaltsamkeit von heterosexuellem Geschlechtsverkehr) oder empfängnisverhütende Methoden zu benutzen sowie Bereitschaft, sich einer Samenspende zu enthalten wie im Folgenden definiert: Bei weiblichen gebärfähigen Partnern müssen Männer während der gesamten Behandlungsperiode und für 6 Monate nach letzter Gabe von Bevacizumab entweder vollständig enthaltsam bleiben oder ein Kondom
zusammen mit einer zusätzlichen empfängnisverhütenden Methode benutzen, die zusammen eine Versagensquote von < 1% pro Jahr haben. Männer dürfen während dieses Zeitraums keine Samenspende vornehmen. Falls der weibliche Partner schwanger ist, müssen Männer sexuell enthaltsam bleiben oder während der gesamten Behandlungsperiode und für 6 Monate nach letzter Gabe von Bevacizumab ein Kondom benutzen, um eine Exposition des Embryo zu vermeiden. Die Verlässlichkeit der sexuellen Enthaltsamkeit sollte in Bezug auf die Dauer der klinischen Prüfung und den bevorzugten und gewöhnlichen Lebensstil des Patienten beurteilt werden. Periodische Abstinenz (z.B. nach der Kalendermethode oder um den Zeitpunkt des Eisprungs, symptothermale Methoden oder periodische sexuelle Enthaltsamkeit von der Menstruation bis nach erfolgtem Eisprung) und Coitus interruptus sind keine akzeptierten Methoden zur Empfängnisverhütung.
Ausschlusskriterien
1. Diffuses HCC , Gefäßeinbruchs durch den Tumor, extrahep, Ausbreitung oder > 7 Läsionen oder eine Läsion = 7 cm
2. Bekanntes fibrolamelläres HCC, sarkomatoides HCC, oder gemischtes Gallengangskarzinom und HCC
3. Klinisch relevanter Aszites (Details s. Prüfplan)
4. Unkontr. Pleura- oder Perikarderguss
5. Anamnese oder Vorliegen von hep. Enzephalopathie
6. Koinfektion mit HBV und HCV, anamnet. HCV Infektion mit neg. PCR auf HCV RNS, gelten als nicht HCV infiziert
7. Patienten, die aktiv auf einer Lebertransplantationsliste gelistet sind oder potentiell transplantiert werden können (siehe Prüfplan)
8. systemische Vor-Behandlung des HCC
9. Vor-Behandlung mit TACE oder SIRT
10. Vorbehandlung mit lokal ablativen Verfahren (Details s. Prüfplan)
11. Jeder Kontraindikation für TACE
12. Größere gastrointestinale Blutungen in den letzten 4 Wochen
13. Unbehandelte oder unvollst. Behandel. Oesophagusvarizen mit Blutung oder hohem Blutungs-Risiko (Details siehe Prüfpaln)
14. Aktive Autoimmunerkrankung, Immunschwäche oder Anamnese einer solchen(Details s. Prüfplan)
15. Frühere allogene Stammzelltransplantation oder Organtransplantation.
16. Bekannte idiop. Pulm. Fibrose, organisierende Pneumonie, Arzneimittel-induz. Pneumonitis, idiopathische Pneumonitis oder Nachweis einer aktiven Pneumonitis im CT (Details siehe Prüfplan)
17. Aktive Tuberkulose (Details siehe Protokoll)
18. Schwere Infektion innerhalb der letzten 4 Wochen (Details s. Prüfplan)
19. Signifikante kardiovaskuläre Erkrankung (Details siehe Prüfplan)
20. Bekanntes angeborenes Langes-QT Syndrom, korr. QT-Interval > 500 msec oder wiederholt korr. QT-Intervall von >450 ms
21. Unkontrollierte art. Hypertonie, frühere Anamnese einer hypertensiven Krise oder einer hypertensiven Enzephalopathie.
22. Signif. Gefäßerkrankung (Details s. Prüfplan)
23. Anamnese einer abdom. oder tracheoösophagealen Fistel, einer gastroint. Perforation oder intraabdominalen Abszesses innerhalb der letzten 6 Monaten
24. Anamnese oder klin. Zeichen einer gastroint. Obstruktion, routinemäßige parenterale Flüssigkeitszufuhr/Ernährung oder Ernährungssonde.
25. Bekannter intra-abdominaler entzündlicher Prozess innerhalb der letzten 6 Monaten
26. Blutungsneigung oder signifikanten Gerinnungsstörung
27. Jede andere Kontraindikation für den Gebrauch der Prüfpräparte oder die die Interpretation der Ergebnisse beeinflussen könnten oder den Patienten einem hohen Risiko aussetzen könnten.
28. Nicht kontrollierter tumorbedingter Schmerz
29. Schwere, nicht heilende/klaffende Wunden, aktives Ulkus oder unbehandelte Knochenfraktur
30. andere malignen Erkrankung als ein HCC (Ausnahmen s. Prüfplan)
31. Fortbestehende oder kürzliche Gabe von Acetylsalicylsäure oder Behandlung mit Dipyramidol, Ticlopidin, Clopidogrel und Cilostazol
32. Fortbestehende oder kürzliche Gabe von voll dosierten oral oder parenteral verabreichten Antikoagulantien, thrombolytischen Agentien (Details s. Prüfplan)
33. Chronische tägl. Gabe von NSAID
34. Impfung mit Lebendimpfstoff innerhalb der letzten 4 Wochen (Details s. Prüfplan)
35. Frühere Behandlung mit CD137 Agonisten oder Immun-Checkpoint-Blockade Therapien
36. Überempfindlichkeit auf Atezolizumab oder Bevacizumab oder Bestandteile ihrer Zubereitung, gegen Produkte aus CHO-Zellen oder gegen humane oderhumanisierte Antikörper
37. Behandlung mit syst. immunstimulierenden Wirkstoffen (Details s. Prüfplan)
38. Behandlung mit systemischer immunsuppressiver Medikation (Details s. Prüfplan)
39. Größerer chirurgischer Eingriff mit Ausnahme solcher zur Diagnosestellung, eine offene Biopsie oder eine signifikante traumatische Verletzung innerhalb von 28 Tagen vor Randomisierung, oder ein chirurgischer Eingriff im Bauch, chirurgische Interventionen oder eine signifikante traumatische Bauchverletzung innerhalb von 60 Tagen vor Randomisierung oder die Annahme, dass im Verlauf der Studie größere chirurgische Maßnahmen erforderlich sein könnten oder ausgebliebene Erholung von den Nebenwirkungen solcher Eingriffe.
40. Stanz- oder Feinnadelbiopsien, andere kleinere chirurgische Maßnahmen innerhalb von 3 Tagen vor erster Gabe von Bevacizumabmit Ausnahme von Legen von Gefäßzugängen.
41. Schwangere oder stillende Frauen.
42. Teilnahme an einer klinischen Studie oder experimentelle medikamentöse Therapie innerhalb von 28 Tagen vor Studieneinschluss oder innerhalb von 5 Halbwertzeiten der in einer klinischen Prüfung oder während einer experimentellen medikamentösen Behandlung verabreichten Wirkstoffe vor Studieneinschluss in Abhängigkeit davon, welcher Zeitraum länger ist, oder gleichzeitige Teilnahme an einer anderen klinischen Studie während der Teilnahme an dieser klinischen Studie.
43. Patient ist auf Grund einer gerichtlichen Verfügung oder Anordnung der administrativen Behörden in eine Anstalt eingewiesen.
44. Mögliche Abhängigkeit des Patienten vom Prüfarzt, einschließlich Ehegatte, Kinder und naher Verwandter eines jeden Prüfarztes
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Tumoren der Leber und Bauchspeicheldrüse und der Gallenwege
Medizinischer Befund
Nicht-resezierbares Hepatozelluläres Karzinom
MedDRA Term
Hepatocellular carcinoma non-resectable
RACC-Trial
The RACC trial: Robot-assisted Approach to Cervical Cancer. A multi-centre open-label randomised non-inferiority trial of robot-assisted laparoscopic surgery versus laparotomy in women with early stage cervical cancer
Berufsordnung (BO) / Interventionell, Multizentrisch
Zurück
RACC-Trial
Studieninformationen
Studien-Code
UME-ID-9100
Studien-Akronym
RACC-Trial
Studientitel
The RACC trial: Robot-assisted Approach to Cervical Cancer. A multi-centre open-label randomised non-inferiority trial of robot-assisted laparoscopic surgery versus laparotomy in women with early stage cervical cancer
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022
Beteiligte
Institute
Klinik für Frauenheilkunde und Geburtshilfe, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Paul Buderath

85239
paul.buderath@uk-essen.de

Hufelandstr 55
45147 Essen

Studiendesign
offen, Multizentrisch
Einschlusskriterien
- Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix;
- Patients with histologically confirmed stage IB (IB3 excluded) and IIA1, according to the latest revision of the FIGO staging manual
- Patients undergoing either a Type B or C radical hysterectomy (Querleu and Morrow classification)
- Patients with adequate bone marrow, renal and hepatic function
- ECOG Performance Status of 0, 1 or 2.
- Patient must be suitable candidates for surgery.
- Patients who have signed an approved Informed Consent
- Age 18 years or older
Ausschlusskriterien
- Any histology other than adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix
- Tumor size greater than 4 cm
- FIGO stage II-IV (except IIA1)
- Patients with a history of pelvic or abdominal radiotherapy
- Patients who are pregnant
- Patients with contraindications to surgery
- Patients with evidence of metastatic disease by conventional imaging, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
- Patients with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1N0M0 grade 1 or 2 without any signs of recurrence or activity)
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Weiblich
Indikation
Gynäkologische Tumore
Medizinischer Befund
Cervical Cancer
Besremi-PASS EUPAS29462
A Prospective, Multicentre, Non-interventional, Observational, Post-authorisation Safety Study of Ropeginterferon alfa-2b in Polycythaemia Vera Patients
Berufsordnung (BO) / Nicht-interventionell, Multizentrisch
Zurück
Besremi-PASS EUPAS29462
Studieninformationen
Studien-Code
UME-ID-9160
Studien-Akronym
Besremi-PASS EUPAS29462
Studientitel
A Prospective, Multicentre, Non-interventional, Observational, Post-authorisation Safety Study of Ropeginterferon alfa-2b in Polycythaemia Vera Patients
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Joachim Göthert

+49 (0)201 723-82530
joachim.goethert@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

AOP Orphan Pharmaceuticals AG, Wien

Studiendesign
Anwendungsbeobachtung von Arzneimitteln (AWB), Multizentrisch
Einschlusskriterien
1. Patients who receive ropeginterferon alfa-2b in the frame of clinical routine and according to its approved labelling: monotherapy in adults (≥ 18 years old) for the
treatment of PV without symptomatic splenomegaly and according to the recommendations in the product information for ropeginterferon alfa-2b (Annex 1)
2. Patient’s medical history is available
3. Patient provides written informed consent prior to study entry
Ausschlusskriterien
1. Patients with any contraindication to ropeginterferon alfa-2b treatment according to the product information for ropeginterferon alfa-2b (Annex 1)
2. Patients involved in any study with another investigational product or therapy (in the prior 30 days)
3. Previous ropeginterferon alfa-2b treatment
4. Patient is a family member or employee of the Investigator
Indikation
MPN - Myeloproliferative Neoplasie
Medizinischer Befund
Polycythämia Vera
ACT15378
Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia In First or Second Relapse
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
EudraCT-Nummer: 2018-002697-45
Zurück
ACT15378
Studieninformationen
Studien-Code
UME-ID-9169
Studien-Akronym
ACT15378
Studientitel
Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia In First or Second Relapse
Aktueller Studienstatus
Geschlossen
Studie aktiv in den Jahren
2022
EudraCT-Nummer: 2018-002697-45
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Dirk Reinhardt

+49 (0)201 723-3784
dirk.reinhardt@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Sanofi-Aventis Recherche & Développement, Frankreich

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
- Participant must be 28 days to less than 18 years of age, at the time of signing the informed consent.
- Participants must have a confirmed diagnosis of relapsed Acute Lymphoblastic Leukemia (ALL) of T- or B-cell origin including T-lymphoblastic lymphoma (LBL), or relapsed Acute Myeloblastic Leukemia (AML) including participants with history of myelodysplasia.
- Participants must be previously treated for their disease and have relapsed or are refractory to most recent treatment. Participants in first or second relapse will be eligible regardless of the remission duration.
- Participants with no more than 1 prior salvage therapy.
Ausschlusskriterien
- Any serious active disease or co-morbid condition which, in the opinion of the Investigator, may interfere with the safety of the study treatment or the compliance with the study protocol.
- Participants must have been off prior treatment with immunotherapy/investigational agents and chemotherapy for >2 weeks and must have recovered from acute toxicity before the first study treatment administration. Treatment may start earlier if necessitated by the patient's medical condition (eg, rapidly progressive disease) following discussion with the Sponsor.
- Prior stem cell transplant within 3 months and/or evidence of active systemic Graft versus Host Disease (GVHD) and/or immunosuppressive therapy for GVHD within 1 week before the first study treatment administration.
- Participants with LBL with bone marrow blasts <5%.
- Participants with Burkitt-type ALL.
- Acute leukemia with testicular or central nerve system involvement alone.
- Participants who have developed therapy related acute leukemia.
Studienteilnehmende Mindestalter
28 Tag(e)
Studienteilnehmende Höchstalter
17 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination with Chemotherapy in Pediatric Patients from 28 Days to Less than 18 Years of Age with Relapsed\/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse
MedDRA Term
Acute lymphocytic leukaemia, Acute myeloid leukaemia
ALCL-VBL
International cooperative prospective study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
International study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine
Therapielinie: ED - Erstlinie EudraCT-Nummer: 2017-002935-40
Zurück
ALCL-VBL
Studieninformationen
Studien-Code
UME-ID-9251
Studien-Akronym
ALCL-VBL
Studientitel
International cooperative prospective study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine
Kurzbeschreibung
International study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine
Therapielinie:
ED - Erstlinie
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021
EudraCT-Nummer: 2017-002935-40
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Dr. med. Stefan Schönberger

stefan.schoenberger@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

German Pediatric Oncology Group, GPOH gGmbH, Berlin

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
• Stratification into the standard risk group (SR) by screening:
o Newly diagnosed ALK-positive ALCL
o Stage I not completely resected, or stage II or stage III
o MDD negative
• Age < 18 years
• Informed consent of the parents/legal guardians (and assent of the competent child) for study participation and data collection, storage and handling given before study entry
• Participation in national / study group's reference pathology
• Follow-up for at least 3 years after enrolment is expected
• Application of a highly effective contraceptive method (Pearl index <1) in sexually active patients
Ausschlusskriterien
• Progressive disease during a possible clinically indicated pre-phase treatment before inclusion in the study
• Steroids for more than 2 days or chemotherapy pre-treatment before taking the screening sample for MDD
• Chemotherapy pre-treatment before start of the study treatment except for
o the obligatory initial intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone respectively)
o a possible clinically indicated pre-phase including up to 5 days of steroids combined with up to 3 doses of Vinblastine (and up to 2 doses of Cyclophosphamide)
• Pregnancy or lactation period
• Contraindications for the treatment with Vinblastine:
o hypersensitivity against VBL or other vinca-alkaloids
o leukopenia, other than in the context of the ALCL
o severe uncontrolled infection
• Other medical, psychiatric, familial or social condition prohibiting treatment according to the protocol
Studienteilnehmende Mindestalter
0 Tag(e)
Studienteilnehmende Höchstalter
17 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
standard risk ALK-positive anaplastic large cell lymphoma (ALCL)
CADPT01C12101
A Phase Ib, multicenter, open-label dose escalation and expansion platform study of select drug combinations in adult patients with advanced or metastatic BRAF V600 colorectal Cancer.
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.
EudraCT-Nummer: 2019-004688-27
Zurück
CADPT01C12101
Studieninformationen
Studien-Code
UME-ID-9325
Studien-Akronym
CADPT01C12101
Studientitel
A Phase Ib, multicenter, open-label dose escalation and expansion platform study of select drug combinations in adult patients with advanced or metastatic BRAF V600 colorectal Cancer.
Kurzbeschreibung
A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2020,2021,2022,2023
EudraCT-Nummer: 2019-004688-27
Beteiligte
Institute
Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Stefan Kasper-Virchow

+49 (0) 201 723-2040
stefan.kasper-virchow@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Novartis Pharma Schweiz AG

+41 41 763 71 11

Suurstoffi 14
6343 Rotkreuz

Studiendesign
nicht-randomisiert, offen, Multizentrisch, International
Einschlusskriterien
Key Inclusion Criteria:

- Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at baseline and during on study therapy. Exceptions may be considered after documented discussion with Novartis.
- All patients must have a BRAF V600 mutation confirmed by local assessment.
- Patients with unresectable advanced/metastatic BRAF V600 cancer of the colon or rectum with measurable disease as determined by RECIST v1.1
- Patients must have documented disease progression following, or are intolerant to, 1 or 2 lines of chemotherapy for advanced/metastatic disease
Ausschlusskriterien
Key Exclusion Criteria:

- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in-situ cervical cancer, or other tumors that will not affect life expectancy
- Impairment of gastrointestinal function or gastrointestinal disease that may signficantly alter the absorption of study drugs
- History of or current evidence/risk of retinal verin occlusion or serous retinopathy
- History of or current interstitial lung disease or non-infectious pneumonitis
- Patients with a known history of testing positive for HIV
- Clinically significant cardiac disease at screening
- Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- Pregnant or lactating women
Other protocol-defined inclusion/exclusion may apply.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Tumoren des Magen-Darm-Traktes
Medizinischer Befund
BRAV V600 Colorectal Cancer
PRIMORDIUM
A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients with PSMA-PET-Positive Hormone-Sensitive Prostate Cancer, with an Observational Follow-up of PSMA-PET-Negative Patients.
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
A research study to assess the efficacy and safety of apalutamide in the treatment of high-risk Hormone-Sensitive Prostate Cancer assessed by an imaging scan.
EudraCT-Nummer: 2019-002957-46
Zurück
PRIMORDIUM
Studieninformationen
Studien-Code
UME-ID-9341
Studien-Akronym
PRIMORDIUM
Studientitel
A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients with PSMA-PET-Positive Hormone-Sensitive Prostate Cancer, with an Observational Follow-up of PSMA-PET-Negative Patients.
Kurzbeschreibung
A research study to assess the efficacy and safety of apalutamide in the treatment of high-risk Hormone-Sensitive Prostate Cancer assessed by an imaging scan.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2024
EudraCT-Nummer: 2019-002957-46
Beteiligte
Institute
Klinik für Urologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Boris Hadaschik

+49 (0)201 723-3213
urologie.studien@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Janssen-Cilag International NV (BE)

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
- Histologically confirmed adenocarcinoma of the prostate
- Previously treated with radical prostatectomy with or without lymph node dissection and either: a) for biochemical recurrence after radical prostatectomy (RP): any post-operative prostate-specific antigen (PSA) measurement of less than (=) 0.1 ng/mL within the 4 to 8-week period after RP or b) for persistent PSA after RP: PSA >=0.1 ng/mL within the 4 to 8-week period after RP, confirmed by additional measurement at least 3 weeks later
- Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce
- Results of the Prostate specific membrane antigen-positron emission tomography (PSMA-PET) at screening as determined by blinded independent, central review (BICR), must be: PSMA-PET-negative for any prostate cancer lesions (that is, no loco-regional lesion and no distant lesions); or PSMA-PET-positive for at least one loco-regional (pelvic) lesion without distant extra-pelvic lesion; or PSMA PET- positive for at least one loco--regional (pelvic) lesion with extra-pelvic lesion(s).
- High risk of developing metastasis defined as; a) for biochemical recurrence after RP: pathological Gleason score greater than or equal to (>=) 8 evaluated from prostate tissue specimen at radical prostatectomy, or prostate-specific antigen doubling time (PSADT) less than or equal to (=8, evaluated from prostate tissue specimen at radical prostatectomy
- Participants with evidence of distant metastasis on screening PSMA-PET scan must have no evidence of prostate cancer metastases on screening CT/MRI of the chest/abdomen/pelvis, Technetium 99m [99mTc] whole-body bone scan. Participants with a single bone lesion on 99mTc whole-body bone scan should have confirmatory imaging by CT or MRI; if the confirmatory scan confirms the bone lesion, the participant should be excluded from the study. Conventional images (99mTc-bone scan and CT/MRI) from the screening will be evaluated locally before randomization
- Eastern Cooperative Oncology Group Performance Status Grade 0 or 1
Ausschlusskriterien
- History of pelvic radiation for malignancy
- Previous treatment with androgen deprivation therapy (ADT) for prostate cancer
- Previously treated for biochemical recurrence (BCR) or persistent PSA after RP (previous surgical treatment of one or more loco-regional lesions is allowed)
- Prior treatment with a CYP17 inhibitor (example, oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any androgen receptor (AR) antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy
- Known or suspected contraindications or hypersensitivity to apalutamide, Luteinizing Hormone-Releasing Hormone (LHRH) agonist or any of the components of the formulations
- Prior chemotherapy for prostate cancer
- Any evidence of prostate cancer metastasis on computed tomography/magnetic resonance imaging (CT/MRI) of the chest/abdomen/pelvis or 99mTc whole-body bone scan, at any time prior to screening
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich
Indikation
Urogenitale Tumore
Medizinischer Befund
High risk recurrent prostate cancer previously treated with radical prostatectomy
MedDRA Term
Prostate cancer recurrent
73841937NSC1001 / Chrysalis
An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ-73841937 (Lazertinib), a Third Generation EGFRTKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (Phase 1b), to characterize the safety and tolerability of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced non-small cell…
EudraCT-Nummer: 2020-000747-31
Zurück
73841937NSC1001 / Chrysalis
Studieninformationen
Studien-Code
UME-ID-9492
Studien-Akronym
73841937NSC1001 / Chrysalis
Studientitel
An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ-73841937 (Lazertinib), a Third Generation EGFRTKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer
Kurzbeschreibung
The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (Phase 1b), to characterize the safety and tolerability of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced non-small cell lung cancer (NSCLC) with documented advanced or metastatic epidermal growth factor receptor (EGFR) mutation (Phase 1b expansion cohorts A, B and C), to estimate the antitumor activity of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced NSCLC with documented advanced or metastatic EGFR mutation (Phase 1b expansion cohorts A, B and C), to identify the recommended Phase 2 dose (RP2ChD) of Lazertinib when combined with Amivantamab and standard of care chemotherapy and to determine the tolerability of the Lazertinib, Amivantamab, and platinum-doublet chemotherapy (LACP) combination (Phase 1b LACP combination cohort) and to characterize the safety and tolerability of Lazertinib at the RP2ChD and Amivantamab and standard of care chemotherapy in participants with advanced or metastatic EGFR-mutated NSCLC (Phase 1b LACP combination cohort), to assess 2 potential biomarker strategies to identify participants at increased, or decreased, probability of tumor response with JNJ-61186372 and lazertinib combination in participants with EGFR Exon19del or L858R mutated NSCLC progressed on or after osimertinib (Phase 1b expansion Cohort D).
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022
EudraCT-Nummer: 2020-000747-31
Beteiligte
Institute
Innere Klinik (Tumorforschung), Ruhrlandklinik - Thorakale Onkologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Marcel Wiesweg

marcel.wiesweg@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Janssen-Cilag International NV (BE)

Studiendesign
nicht-randomisiert, offen, Multizentrisch, International
Einschlusskriterien
- Phase 1 and Phase 1b lazertinib+Amivantamab combination cohorts: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with previously epidermal growth factor receptor (EGFR) mutation (identified locally in a Clinical Laboratory Improvement Amendments [CLIA]-certified laboratory [or equivalent]) that is metastatic or unresectable, and have progressed after standard of care front-line therapy, and exhausted available options with targeted therapy. A participant who has refused all other currently available therapeutic options is allowed to enroll
- For the Phase 1b Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP) combination cohort: histologically or cytologically confirmed advanced or metastatic EGFR-mutated NSCLC who have progressed on or after an EGFR-TKI as the most recent line of treatment with a maximum of 3 prior lines of therapy in the metastatic setting allowed
- For all expansion cohorts, the EGFR mutation must have been previously histologically or cytologically characterized, as performed by a CLIA-certified (US sites) or an accredited (outside of US) local laboratory, with a copy of the mutation analysis being submitted during screening (Phase 1b expansion Cohort B, C and D)
1. Expansion Cohort A: Participant must have advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) that has progressed on prior treatment with osimertinib in the first or second line, followed by progression on a platinum-based chemotherapy regimen as the last line of therapy prior to study enrollment. Prior use of first or second generation EGFR tyrosine kinase inhibitor (TKI) is allowed if administered prior to osimertinib
2. Expansion Cohort B: Participant must have previously treated, advanced or metastatic NSCLC with documented primary EGFR Exon 20ins activating mutation. Participants should have been treated with standard of care, platinum-based chemotherapy regimens, but may have treated with approved EGFR TKI, investigational EGFR, or immunotherapy agents if refusing front line platinum-based chemotherapy standard of care. Up to 3 lines of prior systemic anti-cancer treatment are allowed
3. Expansion Cohort C: Participant must have advanced or metastatic NSCLC characterized by an uncommon activating mutation Additional uncommon EGFR mutations/alterations, beyond those listed above, may be considered for enrollment after agreement with the medical monitor. Participants may be treatment naïve or have been treated with one prior line of therapy which must be a first or second generation TKI (that is gefitinib, erlotinib, afatinib) in the most recent line of therapy. Prior chemotherapy is allowed if administered prior to EGFR TKI therapy, or as the only systemic anti-cancer therapy prior to study enrollment. Up to 2 lines of prior systemic anti-cancer treatment are allowed
4. Expansion Cohort D: Participant must have advanced or metastatic EGFR-mutated NSCLC (EGFR Exon19 deletion or L858R) that has progressed on prior treatment with osimertinib in the first or second line (after first- or second-generation EGFR TKI), as the immediate prior line of therapy. Only previous treatment in the metastatic setting with a first, second, or third generation EGFR TKI is allowed
- Evaluable disease
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- Participants must meet the study protocol defined laboratory criteria without having a history of red blood cell transfusion, platelet transfusion, or granulocyte-colony stimulating factor support within 7 days prior to the date of the test
- A woman of childbearing potential: Must have a negative serum beta human chorionic gonadotropin at screening; Must agree not to breast-feed during the study and for 6 months after the last dose of study intervention. (Enrollment is not allowed even if a woman who is breast-feeding stops breast-feeding); Must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study intervention
Ausschlusskriterien
- Participant has an uncontrolled illness, including but not limited uncontrolled diabetes, ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics week prior to study treatment] or diagnosed or suspected viral infection); active bleeding diathesis; Impaired oxygenation requiring continuous oxygen supplementation; Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of study treatment; or psychiatric illness or any other circumstances including (social circumstances) that would limit compliance with study requirements. Any ophthalmologic condition that is either clinically unstable or requires treatment
- Prior treatment with antiPD-1 or anti Programmed death-ligand 1 (PD-L1) antibody within 6 weeks of planned first dose of study intervention
- Untreated brain or other central nervous system (CNS) metastases whether symptomatic or asymptomatic. Participants who have completed definitive therapy, are not on steroids, and have a stable clinical status for at least 2 weeks prior to study treatment may be eligible for Phase 1b expansion cohorts. If brain metastases are diagnosed on Screening imaging, the participant may be enrolled, or rescreened for eligibility, after definitive treatment if above criteria are met
- Any Toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade <=2 peripheral neuropathy, and Grade <=2 hypothyroidism stable on hormone replacement therapy)
- Allergies, hypersensitivity, or intolerance to Lazertinib or JNJ-61186372 or their excipients. For the LACP combination cohort: participant has a contraindication for the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Lungenkrebs
Medizinischer Befund
Advanced Non- Small Cell Lung Cancer
I3Y-MC-JPCS
A Phase 1b Dose Escalation Study of Abemaciclib in Combination with Temozolomide and Irinotecan (Part A) and Abemaciclib in Combination with Temozolomide (Part B) in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
A Phase 1b Study of Abemaciclib Plus Chemotherapy in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors
EudraCT-Nummer: 2019-002931-27
Zurück
I3Y-MC-JPCS
Studieninformationen
Studien-Code
UME-ID-9536
Studien-Akronym
I3Y-MC-JPCS
Studientitel
A Phase 1b Dose Escalation Study of Abemaciclib in Combination with Temozolomide and Irinotecan (Part A) and Abemaciclib in Combination with Temozolomide (Part B) in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors
Kurzbeschreibung
A Phase 1b Study of Abemaciclib Plus Chemotherapy in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2022
EudraCT-Nummer: 2019-002931-27
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Dirk Reinhardt

+49 (0)201 723-3784
dirk.reinhardt@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Eli Lilly & Company, USA

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
- Participants must be ≤18 years of age at the time of study enrollment
- Body weight ≥10 kilograms and body surface area (BSA) ≥0.5 meters squared.
- Participants with any relapsed/refractory solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies and, in the judgment of the investigator, are appropriate candidates for the experimental therapy combination in the study part that is currently enrolling.
- A Lansky score ≥50 for participants ≤16 years of age, and Karnofsky score ≥50 for participants >16 years of age.
- Participants must have discontinued all previous treatments for cancer or investigational agents and must have recovered from the acute effects to Grade ≤1 at the time of enrollment.
- Able to swallow intact capsules.
- Adequate hematologic and organ function ≤2 weeks (14 days) prior to first dose of study drug.
- Females of reproductive potential must have negative serum pregnancy test at baseline (within 7 days prior to starting treatment).
- Both female and male participants of reproductive potential must agree to use highly effective contraceptive precautions (and avoid sperm donation for males) during the trial. For abemaciclib, females should use contraception for at least 3 weeks following the last abemaciclib dose (males have no restriction for contraceptive use following treatment with abemaciclib). For other study drugs, highly effective contraceptive precautions (and avoiding sperm donation) must be used according to their label.
- Life expectancy of at least 8 weeks and able to complete at least 1 cycle of treatment.
- Caregivers and participants are willing to make themselves available for the duration of the trial.
Ausschlusskriterien
- Received allogenic bone marrow or solid organ transplant.
- Received live vaccination (within 4 weeks prior to starting study treatment).
- Participants with psychiatric illness/social situation that, in the opinion of the investigator, could cause unacceptable safety risks or compromise compliance with the protocol.
- Have a personal history of any of the following conditions within the last 12 months: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
- Intolerability or hypersensitivity to any of the study treatments or its components relevant to the study part that is currently enrolling or a known hypersensitivity to dacarbazine.
- Diagnosed and/or treated additional malignancy within 3 years prior to enrollment that may affect the interpretation of results, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or breast cancers.
- Pregnant or breastfeeding.
- Active systemic infections or viral load.
- Serious and/or uncontrolled preexisting medical condition(s) that would preclude participation in this study (such as severe renal impairment, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn’s disease or ulcerative colitis or a preexisting chronic condition resulting in clinically significant diarrhea).
- Treated with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450 3A (CYP3A) or strong inhibitors of UGT1A1 if the treatment cannot be discontinued or switched to a different medication at least 5 half-lives prior to starting study drug.
- Received prior treatment with cyclin-dependent kinase (CDK) 4 & 6 inhibitor.
- Currently enrolled in any other clinical study involving an investigational product or non-approved use of a drug or device.
- Has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
- Tumor contains known RB (retinoblastoma) mutation. Screening is not required for enrollment.
- Participants with a bowel obstruction will be excluded from Part A of this study.
Studienteilnehmende Mindestalter
28 Tag(e)
Studienteilnehmende Höchstalter
17 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
Pediatric and Young Adult Patients Relapsed\/Refractory Solid Tumors
MedDRA Term
Ewing's sarcoma, Neuroblastoma, Rhabdoid tumor, Rhabdomyosarcoma, Osteosarcoma, Glioblastoma, Diffuse intrinsic pontine glioma, Malignant glioma, Medulloblastoma, Ependymoma, Solid tumor
Novartis CNIZ985B12101
A Phase I/Ib Study of Subcutaneous Recombinant NIZ985 ((het-IL-15) (IL-15/sIL-15Ra)) in combination with Spartalizumab (PDR001) in patients with check point inhibitor (CPI) relapsed advanced solid tumors and lymphoma
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
EudraCT-Nummer: 2019-004069-42
Zurück
Novartis CNIZ985B12101
Studieninformationen
Studien-Code
UME-ID-9565
Studien-Akronym
Novartis CNIZ985B12101
Studientitel
A Phase I/Ib Study of Subcutaneous Recombinant NIZ985 ((het-IL-15) (IL-15/sIL-15Ra)) in combination with Spartalizumab (PDR001) in patients with check point inhibitor (CPI) relapsed advanced solid tumors and lymphoma
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2021,2023
EudraCT-Nummer: 2019-004069-42
Beteiligte
Institute
Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Schuler

martin.schuler@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Novartis Pharma GmbH

+499112730
infoservice.novartis@novartis.com

Roonstraße 25
90429 Nürnberg

Studiendesign
nicht-randomisiert, offen, Multizentrisch, International
Einschlusskriterien
1. Signed informed consent must be obtained prior to participation in the study.
2. Male or female patients ≥ 18 years of age
3. Histologically confirmed and documented advanced solid tumors and lymphoma (includes locally advanced malignancies that are not curable by surgery or radiotherapy, and those with metastatic disease) with documented progression following standard therapy, and for whom, no standard therapy is available, tolerated or appropriate. Disease must be measurable as determined by RECIST 1.1 (refer to Appendix 1) or Cheson et al (2014) (refer to Appendix 6).
- Escalation: Patients previously treated with CPI (anti PD-1/PD-L1 and/or anti CTLA-4) who have previously responded and progressed at any time prior to enrollment. Previous response is an initial radiographic CR/PR (a confirmatory scan is not required). If the most recent regimen included CPI, patients with SD lasting ≥ 6 months are also eligible.
- Expansion in melanoma: Patients with cutaneous melanoma previously treated with CPI (anti PD 1/ PD-L1 and/or anti CTLA-4) who have previously responded and progressed at any time prior to enrollment. Previous response is radiographic CR/PR (a confirmatory scan is not required). If the most recent regimen included CPI, patients with SD lasting ≥ 6 months are also eligible.
- Expansion in NSCLC: Patients with locally advanced or unresectable NSCLC who have been treated with up to 2 prior lines of therapies, at least one of which was a CPI-containing regimen (anti PD 1/ PD-L1 and/or anti CTLA-4). Patients must have previously responded to CPI and progressed at any time prior to enrollment. Previous response is radiographic CR/PR (a confirmatory scan is not required). If the most recent regimen included CPI, patients with SD lasting ≥ 6 months are also eligible. Patients with actionable mutations will be excluded.
4. Patients must be willing and able to comply with the protocol for the duration of the study
5. Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening and during therapy on the study.
6. ECOG performance status ≤1 and in the opinion of the investigator, likely to complete at least 28 days of treatment.
Ausschlusskriterien
1. Patients that have received any prior IL-15 treatment.
2. History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients. In addition, patients with a history of immune mediated toxicities from CPI that led to permanent discontinuation of CPI treatment will be excluded.
3. Patients with primary CNS tumors are excluded. Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids 2 weeks prior to study entry. Patients with treated symptomatic brain metastases should be neurologically stable (for 4 weeks post-treatment and prior to study entry) and at a dose of = 10 mg per day prednisone or equivalent for at least 2 weeks before administration of any study treatment.
4. Systemic chronic steroid therapy (> 10mg/day prednisone or equivalent) or any immunosuppressive therapy, other than replacement-dose steroids in the setting of adrenal insufficiency, within 7 days of the first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed.
5. Malignant disease, other than that being treated in this study, that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or other tumors that will not affect life expectancy.
6. Patients having out of range lab values during screening and before the first dose of study treatment. Out of range lab values are defined as:
- Absolute neutrophil count (ANC) <1.0 x 109/L
- Platelets <75 x 109/L
- Hemoglobin (Hgb) < 9 g/dL
- Serum creatinine > 1.5 x ULN or creatinine clearance < 60mL/min using Cockcroft-Gault formula (See Appendix 3)
- Total bilirubin > 1.5 x ULN, (except for patients with Gilbert's syndrome > 3.0 x ULN or direct bilirubin > 1.5 x ULN)
- Aspartate transaminase (AST) > 3 x ULN
- Alanine transaminase (ALT) > 3x ULN
-Serum electrolytes = grade 2 despite adequate supplementation.
7. Impaired cardiovascular function or clinically significant cardiovascular disease, including any of the following:
- Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade = 2), uncontrolled hypertension or clinically significant arrhythmia
- QTcF >470 msec on screening ECG or congenital long QT syndrome
- Acute myocardial infarction or unstable angina < 3 months prior to study entry
8. Infection(s):
- HIV infection
- Active HBV or HCV infection (per institutional guidelines). Patients with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed in expansion but not in escalation.
- Documented infection. Patients requiring systemic antibiotics for infection must have completed treatment before screening is initiated.
9. Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur may be considered. Patients previously exposed to CPI treatment who were adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
10. History of or current interstitial lung disease or pneumonitis grade = 2.
11. Radiotherapy within 2 weeks of the first dose of study drug, except for palliative radiotherapy to a limited field. To allow evaluation for response to study treatment, patients enrolled in the expansion must have remaining measurable disease that has not been irradiated.
12. Treatment with cytotoxic or targeted antineoplastics within 3 weeks of initiation of study treatment. For cytotoxic agents that have major delayed toxicities, a washout period of one cycle is indicated (examples are nitrosoureas and mitomycin C which typically require a 6 week washout). Prior antibodies or immunotherapies require a 4 week washout. Ongoing bisphosphonate therapy and growth hormone-releasing hormone (GHRH) agonist therapy is allowed. Supportive therapy with denosumab is allowed. For patients with lymphoma, the following washout criteria may be used:
• Systemic antineoplastic therapy (including cytotoxic chemotherapy, alfa-interferon, kinase inhibitors or other targeted small molecules, and toxin immunoconjugates) or any experimental therapy within 14 days or 5 half-lives, whichever is shorter, before the first dose of study treatment
13. Presence of Grade = 2 toxicity according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0), from prior cancer therapy with the exception of neuropathy (inclusion of patients with neuropathy of Grade 2 or less is permitted), ototoxicity, and alopecia.
14. Two weeks since major surgery treatment (mediastinoscopy, insertion of a central venous access device and insertion of a feeding tube are not considered major surgery)
15. Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
16. Use of hematopoietic growth factors or transfusion support = 2 weeks prior to start of study treatment. If growth factors were initiated more than 2 weeks prior to the first dose of study treatment and the patient is on a stable dose, they can be maintained.
17. Any medical condition that would, in the investigator's judgement, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results.
18. Pregnant or nursing (lactating) women.
19. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study medication and for 30 days after the last dose of NIZ985 if receiving NIZ985 alone, 120 days after last dose of tislelizumab, or for 150 days after the last dose of spartalizumab. Highly effective methods of contraception methods include:
- Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
- Female bilateral tubal ligation, female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or total hysterectomy at least six weeks before taking investigational drug(s). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
- Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient
- Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example, hormone vaginal ring or transdermal hormone contraception.
- In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
NOTE: Women are considered post-menopausal and not of child-bearing potential if they have had over 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate [generally age from 40 to 59 years], history of vasomotor symptoms [e.g. hot flush]) in the absence of other medical justification or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks prior to enrollment on study. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.
20. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. Sexually active males receiving NIZ985 as a single agent or in combination with spartalizumab or tislelizumab must use a condom during intercourse for 30 days after their last dose of NIZ985. In addition, male participants must not donate sperm for 30 days after the last dose of NIZ985. Patients should not father a child during this post treatment period. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the drug via semen.
Other protocol-defined inclusion/exclusion criteria may apply
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
HD - Hodgkin Lymphom, NHL - Non-Hodgkin-Lymphom, Solide Tumoren
Medizinischer Befund
solid tumors and lymphoma
CAEL101-302
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment- Naïve Patients with Mayo Stage IIIa AL Amyloidosis
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
EudraCT-Nummer: 2020-000713-32
Zurück
CAEL101-302
Studieninformationen
Studien-Code
UME-ID-9571
Studien-Akronym
CAEL101-302
Studientitel
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment- Naïve Patients with Mayo Stage IIIa AL Amyloidosis
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2023
EudraCT-Nummer: 2020-000713-32
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Alexander Carpinteiro

+49 (0)201 723-82530
alexander.carpinteiro@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Caelum Biosciences, Inc., USA

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
Key Inclusion Criteria:
1. AL amyloidosis stage IIIa based on the European Modification of the 2004 Standard Mayo Clinic Staging who also have NT-proBNP ≥ 650 ng/L at the time of Screening.
2. Measurable hematologic disease at Screening as defined by at least one of the following:
a. dFLC > 4 mg/dL or
b. iFLC > 4 mg/dL with abnormal Kappa/Lambda ratio or
c. SPEP m-spike > 0.5 g/dL
3. Histopathological diagnosis of amyloidosis based on polarizing light microscopy of green bi-refringent material in Congo red stained tissue specimens AND confirmation of AL derived amyloid deposits by at least one of the following:
a. Immunohistochemistry/Immunofluorescence
b. Mass spectrometry or
c. Characteristic electron microscopy appearance/Immunoelectron microscopy
4. Cardiac involvement as defined by:
a. Documented clinical signs and symptoms supportive of a diagnosis of heart failure in the setting of a confirmed diagnosis of AL amyloidosis in the absence of an alternative explanation for heart failure
AND
b. At least one of the following:
i. Endomyocardial biopsy demonstrating AL cardiac amyloidosis or
ii. Echocardiogram demonstrating a mean left ventricular wall thickness (calculated as [IVSd+LPWd]/2) of > 12 mm at diastole in the absence of other causes (e.g., severe hypertension, aortic stenosis), which would adequately explain the degree of wall thickening or
iii. Cardiac MRI with gadolinium contrast agent diagnostic of cardiac amyloidosis
5. Planned first-line treatment for plasma cell dyscrasia is a cyclophosphamide-bortezomib-dexamethasone (CyBorD)-based regimen administered as SoC
6. WOCBP must have a negative pregnancy test during Screening and must agree to use highly effective contraception (Section 6.9) from Screening to at least 5 months following the last study drug administration or 12 months following the last dose of her PCD therapy, whichever is longer
7. Men must be surgically sterile or must agree to use highly effective contraception and refrain from donating sperm from Screening to at least 5 months following the last study drug administration or 12 months following the last dose of their PCD therapy, whichever is longer
Ausschlusskriterien
1. Have any other form of amyloidosis other than AL amyloidosis
2. Received prior therapy for AL amyloidosis or multiple myeloma. A maximum exposure of 2 weeks of a CyBorD-based PCD treatment after screening laboratory samples are obtained and prior to randomization is allowed.
3. Has POEMS syndrome or multiple myeloma defined as clonal bone marrow plasma cells > 10% from a bone marrow biopsy (performed = 3 months prior to signing the ICF or during screening) or biopsy proven (performed = 3 months prior to signing the ICF or during screening) bony or extramedullary plasmacytoma AND any one or more of the following CRAB features:
a. Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder (e.g., multiple myeloma and POEMS syndrome), specifically:
i. Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the ULN or > 2.75 mmol/L (> 11 mg/dL) OR
ii. Renal insufficiency: creatinine clearance 177 mol/L (> 2 mg/dL) OR
iii. Anemia: hemoglobin value of > 20g/L below the lowest limit of normal, or a hemoglobin value < 100 g/L OR
iv. Bone lesions: one or more osteolytic lesion on imaging tests (performed = 3 months prior to signing the ICF or during screening): skeletal radiography, CT, or PET/CT, or MRI. If bone marrow has < 10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement OR
b. Any one of the following biomarkers of malignancy:
i. 60% or greater clonal plasma cells on bone marrow examination OR
ii. More than one focal lesion on MRI that is at least 5mm or greater in size
4. Have supine systolic blood pressure 30 mmHg despite medical management (e.g., midodrine, fludrocortisones) in the absence of volume depletion
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Indikation
AL-Amyloidose
Medizinischer Befund
stage IIIa cardiac AL amyloidosis
MedDRA Term
Cardiac amyloidosis
CAEL101-301
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment- Naïve Patients with Mayo Stage IIIb AL Amyloidosis
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
EudraCT-Nummer: 2019_004254_28
Zurück
CAEL101-301
Studieninformationen
Studien-Code
UME-ID-9572
Studien-Akronym
CAEL101-301
Studientitel
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment- Naïve Patients with Mayo Stage IIIb AL Amyloidosis
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022,2023
EudraCT-Nummer: 2019_004254_28
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Alexander Carpinteiro

+49 (0)201 723-82530
alexander.carpinteiro@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Caelum Biosciences, Inc., USA

Studiendesign
randomisiert, Multizentrisch, International
Einschlusskriterien
1. AL amyloidosis stage IIIb based on the European Modification of the 2004 Standard Mayo Clinic Staging at the time of Screening, which includes NT-proBNP > 8,500 ng/L.
2. Measurable hematologic disease at Screening as defined by at least one of the following:
a. Involved/uninvolved free light chain difference (dFLC) > 4 mg/dL OR
b. Involved free light chain (iFLC) > 4 mg/dL with abnormal Kappa/Lambda ratio OR
c. Serum protein electrophoresis (SPEP) m-spike > 0.5 g/dL
3. Histopathological diagnosis of amyloidosis based on polarizing light microscopy of green bi-refringent material in Congo red stained tissue specimens AND confirmation of AL derived amyloid deposits by at least one of the following:
a. Immunohistochemistry/Immunofluorescence OR
b. Mass spectrometry OR
c. Characteristic electron microscopy appearance/Immunoelectron microscopy
4. Cardiac involvement as defined by:
a. Documented clinical signs and symptoms supportive of a diagnosis of heart failure in the setting of a confirmed diagnosis of AL amyloidosis in the absence of an alternative explanation for heart failure
AND
b. At least one of the following:
i. Endomyocardial biopsy demonstrating AL cardiac amyloidosis OR
ii. Echocardiogram demonstrating a mean left ventricular wall thickness (calculated as [IVSd+LPWd]/2) of > 12 mm at diastole in the absence of other causes (e.g., severe hypertension, aortic stenosis), which would adequately explain the degree of wall thickening OR
iii. Cardiac magnetic resonance imaging (MRI) with gadolinium contrast agent diagnostic of cardiac amyloidosis
5. Planned first-line treatment for plasma cell dyscrasia is cyclophosphamide-bortezomib-dexamethasone (CyBorD)-based regimen administered as SoC.
6. Women of childbearing potential (WOCBP) must have a negative pregnancy test during Screening and must agree to use highly effective contraception from Screening to at least 5 months following the last study drug administration or 12 months following the last dose of her anti-PCD therapy, whichever is longer
7. Men must be surgically sterile or must agree to use highly effective contraception and refrain from donating sperm from Screening to at least 5 months following the last study drug administration or 12 months following the last dose of their PCD therapy, whichever is longer
Ausschlusskriterien
1. Have any other form of amyloidosis other than AL amyloidosis
2. Received prior therapy for AL amyloidosis or multiple myeloma. A maximum exposure of 2 weeks of a CyBorD-based PCD treatment after Screening laboratory samples are obtained and prior to randomization is allowed.
3. Has POEMS syndrome OR multiple myeloma defined as clonal bone marrow plasma cells > 10% from a bone marrow biopsy (performed = 3 months prior to signing the ICF or during Screening) OR biopsy-proven (performed = 3 months prior to signing the ICF or during Screening) bony or extramedullary plasmacytoma AND any one or more of the following CRAB features:
a. Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, (e.g. multiple myeloma and PEOMS syndrome) specifically:
i. Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the ULN or > 2.75 mmol/L (> 11 mg/dL) OR
ii. Renal insufficiency: creatinine clearance 177 µmol/L (> 2 mg/dL) OR
iii. Anemia: hemoglobin value of > 20 g/L below the lowest limit of normal, or a hemoglobin value < 100 g/L OR
iv. Bone lesions: one or more osteolytic lesion on imaging tests (performed = 3 months prior to signing the ICF or during Screening): skeletal radiography, CT, or PET/CT, or MRI. If bone marrow has < 10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement OR
b. Any one of the following biomarkers of malignancy:
i. 60% or greater clonal plasma cells on bone marrow examination OR
ii. More than one focal lesion on MRI that is at least 5mm or greater in size
4. Have supine systolic blood pressure 30 mmHg despite medical management (e.g., midodrine, fludrocortisones) in the absence of volume depletion
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Indikation
AL-Amyloidose
Medizinischer Befund
stage IIIb cardiac AL amyloidosis
MedDRA Term
Cardiac amyloidosis
SGN22E-003
An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
EudraCT-Nummer: 2019-004542-15
Zurück
SGN22E-003
Studieninformationen
Studien-Code
UME-ID-9579
Studien-Akronym
SGN22E-003
Studientitel
An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2021,2022
EudraCT-Nummer: 2019-004542-15
Beteiligte
Institute
Klinik für Urologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Viktor Grünwald

+49 (0)201 723-3213
urologie.studien@uk-essen.de

Hufelandstr. 55
45147 Essen

Sponsor

Seattle Genetics, Inc., USA

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
1. Subjects must have histologically documented, unresectable locally advanced or metastatic urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Subjects with squamous or sarcomatoid differentiation or mixed cell types are eligible.
2. Subjects must have measurable disease by investigator assessment according to RECIST v1.1.
a. Subjects with prior definitive radiation therapy must have measurable disease per RECIST v1.1 that is outside the radiation field or has demonstrated unequivocal progression since completion of radiation therapy
3. Subjects must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions:
a. Subjects that received neoadjuvant chemotherapy with recurrence >12 months from completion of therapy are permitted
b. Subjects that received adjuvant chemotherapy following cystectomy with recurrence >12 months from completion of therapy are permitted
4. Subjects must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator’s judgment.
a. Subjects will be considered cisplatin-ineligible, and will receive carboplatin, if they meet at least one of the following criteria:
i. GFR <60 mL/min but ≥30 mL/min (measured by the Cockcroft-Gault formula, Modification of Diet in Renal Disease [MDRD] or 24-hour urine)
· Subjects with a GFR ≥50 mL/min and no other cisplatin ineligibility criteria may be considered cisplatin-eligible based on the investigator’s clinical judgment
ii. ECOG or WHO performance status of 2 (refer to Inclusion 7 for additional criteria for ECOG 2 subjects)
iii. NCI CTCAE Grade ≥2 audiometric hearing loss
iv. NYHA Class III heart failure
5. Subjects must be age 18 years or older.
6. Archival tumor tissue comprising muscle-invasive urothelial carcinoma or a biopsy of metastatic urothelial carcinoma must be provided for PD-L1 testing prior to randomization. If adequate archival tumor sample is not available, or evaluable, a new biopsy sample may be performed.
7. Subjects must have an ECOG Performance Status score of 0, 1, or 2.
a. Subjects with ECOG performance status of 2 must additionally meet the following criteria:
i. Hemoglobin ≥10 g/dL
ii. GFR ≥50 mL/min
iii. May not have NYHA Class III heart failure
8. Subjects must have adequate hematologic and organ function as defined by the baseline laboratory values in Table 3 (see protocol)
9. Female subjects of childbearing potential must meet the following conditions:
· Agree not to try to become pregnant during the study and for at least 6 months after the final dose of study drug.
· Must have a negative urine or serum pregnancy test (minimum sensitivity of 25 mIU/mL or equivalent units of beta human chorionic gonadotropin [β-hCG]) within 1 day prior to administration of the study drug. Female subjects with false positive results and documented verification of negative pregnancy status are eligible for participation.
· If heterosexually active must consistently use highly effective methods of birth control, with a failure rate of less than 1% starting at screening, throughout the study period, and for at least 6 months after the final dose of study drug.
· Female subjects must agree not to breastfeed or donate ova starting at screening and throughout the study period, and for at least 6 months after the final dose of study drug.
10. Male subjects who can father children, must meet the following conditions:
· Must not donate sperm starting at screening and throughout the study period, and for at least 6 months after the final dose of study drug. Male subjects will be informed about the negative risk to reproductive function and fertility from the study treatment. Prior to treatment male subjects should be advised to seek information on fertility preservation and sperm cryoconservation.
· Must consistently use highly effective methods of birth control, with a failure rate of less than 1% starting at screening and continue throughout study period and for at least 6 months after the final dose of study drug.
· Male subjects with a pregnant or breastfeeding partner(s) must consistently use one of 2 contraception options for preventing secondary exposure to seminal fluid for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for at least 6 months after the final dose of study drug.
Ausschlusskriterien
1. Subjects who have previously received enfortumab vedotin or other MMAE-based ADCs.
2. Subjects who have received prior treatment with a PD-(L)-1 inhibitor for any malignancy, including earlier stage UC, defined as a PD-1 inhibitor or PD-L1 inhibitor.
3. Subjects who have previously received any prior treatment with an agent directed to another stimulatory or co inhibitory T-cell receptor.
4. Subjects who have received anti-cancer treatment with chemotherapy, biologics, or investigational agents not otherwise prohibited by exclusion criterion 1-3 that is not completed 4 weeks prior to first dose of study treatment.
5. Subjects with uncontrolled diabetes.
6. Subjects with an estimated life expectancy <12 weeks
7. Subjects with ongoing sensory or motor neuropathy Grade 2 or higher.
8. Subjects with active CNS metastases. Subjects with treated CNS metastases are permitted on study if all of the following are true: a) CNS metastases have been clinically stable for at least 4 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis; b) the subject is on a stable dose of =10 mg/day of prednisone or equivalent for at least 2 weeks (if requiring steroid treatment); c) subject does not have leptomeningeal disease.
9. Subjects with ongoing clinically significant toxicity associated with prior treatment (including radiotherapy or surgery) that has not resolved to = Grade 1 or returned to baseline.
10. Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted.
11. Subjects who have known active hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] detected) infection, testing for hepatitis B and hepatitis C is required if mandated by country health authority. Subjects who have been curatively treated for hepatitis C infection are permitted if they have documented sustained virologic response of 12 weeks.
12. Has a known history of human immunodeficiency virus (HIV) infection. Testing is not required unless mandated by the local health authority.
13. Subjects with conditions requiring high doses of steroids (>10 mg/day of prednisone or equivalent) or other immunosuppressive medications are excluded. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for subjects with adrenal insufficiency.
14. Subjects with a history of another invasive malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy (eligible exceptions see protocol).
15. Subjects with a documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with NYHA Class IV within 6 months prior to randomization.
16. Subjects who have received radiotherapy within 2 weeks prior to randomization.
17. Subjects who have received major surgery within 4 weeks prior to randomization.
18. Subjects with known severe (= Grade 3) hypersensitivity to any excipient contained in the drug formulations of enfortumab vedotin, pembrolizumab, the platinum agent selected by the investigator or gemcitabine.
19. Subjects with active keratitis or corneal ulcerations.
20. History of autoimmune disease that has required systemic treatment in the past 2 years.
a. Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
b. Brief (<7 days) use of systemic corticosteroids is allowed when use is considered standard of care.
c. Subjects with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy will not be excluded.
d. Subjects requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded.
e. Subjects with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome will not be excluded.
21. Subjects with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
22. Subjects who have received a prior allogeneic stem cell or solid organ transplant.
23. Subjects who have received a live attenuated vaccine within 30 days prior to randomization.
24. Subjects with active tuberculosis.
25. Subjects with another underlying medical condition that, in the opinion of the investigator, would impair the ability of the subject to receive or tolerate the planned treatment and follow-up; any known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Urogenitale Tumore
Medizinischer Befund
Urothelial cancer
MedDRA Term
Urothelial carcinoma bladder, Urothelial carcinoma ureter, Urothelial carcinoma urethra
TUD-MOSAIC-075
Midostaurin + Gemtuzumab Ozogamicin als Erstlinientherapie für Patienten mit Akuter Myeloischer Leukämie (AML)
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
EudraCT-Nummer: 2019-003863-23
Zurück
TUD-MOSAIC-075
Studieninformationen
Studien-Code
UME-ID-9616
Studien-Akronym
TUD-MOSAIC-075
Studientitel
Midostaurin + Gemtuzumab Ozogamicin als Erstlinientherapie für Patienten mit Akuter Myeloischer Leukämie (AML)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022,2023
EudraCT-Nummer: 2019-003863-23
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Maher Hanoun

+49 (0)201 723-82530
maher.hanoun@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Technische Universität Dresden

Studiendesign
randomisiert, kontrolliert, Multizentrisch
Einschlusskriterien
Alle Phasen:
 unterschriebene Einwilligungserklärung nach Aufklärung,
 ECOG 0-2,
 Lebenserwartung > 14 Tage,
 Adäquate Leber- und Nierenfunktion
o ALAT/ASAT ≤ 2.5 x ULN;
o Bilirubin < 2 x ULN;
o Creatinin 40 mL/min
Leukozytenzahl < 30 x 109/L. (Hinweis: Hydroxyharnstoff ist erlaubt, um
dieses Kriterium zu erfüllen)
zusätzlich Phase-II-Teil (MAGNOLIA):
 neudiagnostizierte AML nach WHO-Kriterien und entweder
o t(8;21)/RUNX1-RUNX1T1 oder
o inv(16) oder
o t(16;16)/CBFB-MYH11
 Männer und Frauen im Alter von 18 bis ≤ 70 Jahren.
zusätzlich Phase II Studie (MAGMA):
 neudiagnostizierte AML nach WHO-Kriterien und entweder
o FLT3-ITD oder
o FLT3-TKD,
o Negativität für Mutationen im CBF-Gen (z.B. t(8;21)/RUNX1-
RUNX1T1 or inv(16) or t(16;16)/CBFB-MYH11)
 Männer und Frauen im Alter von 18 bis ≤ 70 Jahren,
CAVE: Patienten mit CBF-/FLT3-Co-Mutation werden dem Studienteil
MAGNOLIA zugeordnet.
Ausschlusskriterien
Alle Phasen:
· vorangegangene antineoplastische AML-Therapien, außer
Hydroxyharnstoff,
· vorangegangene Behandlung mit Anthrazyklinen,
· ZNS-Beteiligung,
· Unkontrollierte Infektion,
· Einnahme starker Induktoren von CYP3A4/5, die nicht vor
Studieneinschluss abgesetzt oder ersetzt werden können.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
AML - Akute myeloische Leukämie
Medizinischer Befund
Patienten mit neudiagnostizierter akuter myeloischer Leukämie (AML) und\nzytogenetischen Anomalien bzw. Fusionstranskript der Core-binding-factor-\nGene (CBF) oder eine FLT3-Mutation, die für eine kurative intensive\nErstlinientherapie geeignet sind
PIONEER
Window of opportunity study of preoperative immunotherapy with atezolizumab (Tecentriq®) or FAP-interleukin 2v (IL2v) (RO6874281) in local squamous cell carcinoma of the head and neck (the PIONEER trial)
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Monozentrisch
EudraCT-Nummer: 2018-000254-21
Zurück
PIONEER
Studieninformationen
Studien-Code
UME-ID-9647
Studien-Akronym
PIONEER
Studientitel
Window of opportunity study of preoperative immunotherapy with atezolizumab (Tecentriq®) or FAP-interleukin 2v (IL2v) (RO6874281) in local squamous cell carcinoma of the head and neck (the PIONEER trial)
Aktueller Studienstatus
Geschlossen
Studie aktiv in den Jahren
2021,2022,2023
EudraCT-Nummer: 2018-000254-21
Beteiligte
Institute
Klinik für Hals-Nasen-Ohrenheilkunde, Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Stefan Kasper-Virchow

+49 (0) 201 723-2040
stefan.kasper-virchow@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Universitätsklinik Essen (AöR)

+49 (0)201 723-0
info@uk-essen.de

Hufelandstraße 55
45147 Essen

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Monozentrisch, National
Einschlusskriterien
1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent has to be obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. If laboratory or imaging procedures were performed for alternate reasons prior to signing consent, these can be used for screening purposes with consent of the patient. However, all screening examinations and laboratory results must have been obtained within 14 days before first study drug administration (initial tumor imaging: within 28 days before first study drug administration).
2. Only patients for whom sufficient tumor material to be judged by the local investigator and which is of adequate quality can be included into the trial. Please refer to section 6.5 for further details on quantity and quality of tumor samples.
3. Histologically or cytologically proven SCCHN that is amenable to surgical resection with curative intent.
4. Patients with relapse after primary radio(chemo)-therapy are allowed if a salvage surgery is possible (maximum 20% in each arm). Patients should have recovered from the effects of radiation: AE/sequelae should resolves to ≤ grade 2 (no minimum recovery period required).
5. Male or female, 18 years of age or older on day of signing informed consent
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
7. Life expectancy >12 weeks
8. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
• Absolute neutrophil count (ANC)  1.5  109/L without granulocyte colony-stimulating factor support
• Lymphocyte count  0.5  109/L
• Platelet count  100  109/L without transfusion
• Hemoglobin  90 g/L
o Patients may be transfused to meet this criterion but patients in need of chronic or repeated RBC transfusion should be discussed with the sponsor before.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)  2.5  upper limit of normal (ULN)
• Serum bilirubin  1.5  ULN with the following exception:
o Patients with known Gilbert disease: direct serum bilirubin level  ULN for patients with total bilirubin levels>1.5 ULN.
• Serum creatinine  1.5  ULN or Creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula)
• Serum albumin  2.5 g/dL
• International normalized ratio (INR) or activated Partial Thromboplastin Time (aPTT)  1.5  ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low−molecular weight heparin or warfarin) should be on a stable dose
9. Women of childbearing potential:
• Should have a negative urine or serum pregnancy test within 14 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Agreement to remain abstinent (refrain from heterosexual intercourse) or use a non-hormonal contraceptive method with a failure rate of  1% per year during the treatment period and for at least 5 months after last study drug administration
• A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state ( 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
• Examples of contraceptive methods with a failure rate of  1% per year include bilateral tubal ligation, male sterilization, and copper intrauterine devices.
• The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception. For men: with female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 5 months after the last dose in arm A and B to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
Ausschlusskriterien
1. Evidence of metastatic disease
2. Prior treatment with immune checkpoint blockade therapies,
3. Treatment with investigational therapy within 28 days prior to initiation of study treatment
4. Any anti-cancer therapy, including chemotherapy or hormonal therapy, within 4 weeks prior to initiation of study treatment
5. Bilateral pleural effusion
6. Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1, Cycle 1.
7. Treatment with a live-attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study, and for 5 months after the last dose
8. Treatment with systemic immuno-stimulatory agents within 4 weeks or five half-lives of the drug (whichever is longer) prior to initiation of study treatment
9. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
10. Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment
11. Uncontrolled hypercalcemia
12. Uncontrolled tumor-related pain.
13. Pregnant and lactating women
14. Acute toxicities from previous therapy that have not resolved to Grade = 1, except for alopecia
15. Infections
a. Positive human immunodeficiency virus (HIV) test Known HIV+ patients may be included
b. Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening.
Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening followed by a negative HBV DNA test, are eligible for the study. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
c. Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test at screening.
The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
d. Active tuberculosis
e. Severe infection within 4 weeks prior to initiation of study treatment
f. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
g. Patients receiving prophylactic antibiotics are eligible for the study.
16. Active or history of autoimmune disease or immune deficiency with the following exceptions:
- Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study
- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., no psoriatic arthritis) may be eligible
17. Adverse events (AE) related to any previous radiotherapy, chemotherapy, targeted therapy or surgical procedure that have not reolved to Grade =1, except alopecia (any grade) and Grade 2 neuropathy
18. Prior allogeneic stem cell or solid organ transplantation
19. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computer tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
20. Active malignancy or a prior malignancy within the past 3 years. Patients with completely resected basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in-situ, breast carcinoma in-situ, and patients with isolated elevation in prostate-specific antigen in the absence of radiographic evidence of metastatic prostate cancer are eligible for the study.
21. Any Grade ? 3 hemorrhage or bleeding event within 28 days of Day 1 of Cycle 1
22. Increased corrected QT (QTc) interval (QTc > 470 ms)
23. Family history of long QT syndrome or other risk factors for torsades de pointes
24. History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to Day 1
25. Significant cardiovascular disease
26. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
27. Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject’s safety
28. Participation in another clinical study within the last 3 months prior to inclusion or simultaneous participation in other clinical studies with an exception of studies evaluating radiological imaging.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Kopf-Hals-Tumore
Medizinischer Befund
local squamous cell carcinoma of the head and neck
MedDRA Term
Squamous cell carcinoma of head and neck, Head and neck cancer
GCT3013-01
A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
First-in-Human (FIH) Trial in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
EudraCT-Nummer: 2017-001748-36
Zurück
GCT3013-01
Studieninformationen
Studien-Code
UME-ID-9659
Studien-Akronym
GCT3013-01
Studientitel
A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
Kurzbeschreibung
First-in-Human (FIH) Trial in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021
EudraCT-Nummer: 2017-001748-36
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Bastian von Tresckow

+49 (0)201 723-82530
bastian.vontresckow@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Genmab A/S, Dänemark

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
1. Patient must be 18 years of age or older. Note: In countries where the legal age is 21 years of
age; only patients 21 years of age or older are eligible.
2. Criterion modified as per Amendment 8
2.1 Patient must meet the following entry criteria for the applicable expansion or
optimization cohort:
a. For expansion part R/R aNHL cohort:
i. Documented CD20+ mature B-cell neoplasm according to WHO classification
(Swerdlow et al., 2016) or WHO classification 2008 based on representative
pathology report
1. Diffuse large B-cell lymphoma (de novo or transformed from all indolent
subtypes including Richter’s transformation), including:
a. Patients with “double-hit” or “triple-hit” DLBCL (technically classified in
WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations)
Note: Other double-/triple-hit lymphomas are not eligible
2. Other aggressive B-NHL (beginning in Stage 2):
a. Primary mediastinal (thymic) large B-cell lymphoma (PMBCL)
b. High-grade B-cell lymphoma
c. Follicular lymphoma grade 3B (FL 3B)
ii. Relapsed or refractory disease and previously treated with at least 2 lines of systemic
antineoplastic therapy including at least 1 anti-CD20 monoclonal antibodycontaining
therapy
Note: Relapsed disease is defined as disease that has recurred ≥6 months after
completion of therapy. Refractory disease is defined as disease that either progressed
during therapy or progressed within 6 months (<6 months) of completion of therapy.
iii. Either failed prior autologous hematopoietic stem cell transplantation (HSCT), or
ineligible for autologous HSCT due to age, ECOG performance status,
comorbidities, and/or insufficient response to prior treatment
b. For expansion part R/R iNHL cohort:
i. Documented CD20+ mature B-cell neoplasm according to WHO classification
Swerdlow et al., 2016 (Swerdlow et al., 2016) or WHO classification 2008 based on
representative pathology report
1. Histologic confirmed FL grade 1, 2, or 3A at initial diagnosis without clinical or
pathological evidence of transformation
2. Marginal zone lymphomas (nodal, extranodal, and splenic)
3. Small lymphocytic lymphoma
ii. Relapsed or refractory disease and previously treated with at least 2 lines of systemic
antineoplastic therapy including at least 1 anti-CD20 monoclonal
antibody-containing therapy
Note: Relapsed disease is defined as disease that has recurred ≥6 months after
completion of therapy. Refractory disease is defined as disease that either progressed
during therapy or progressed within 6 months (<6 months) of completion of therapy.
iii. Previously treated with an alkylating agent or lenalidomide
iv. Relapsed or refractory to the last prior line therapy. Previous lymphoma therapy is
defined as 1 of the following: At least 2 months of single-agent therapy, at least
2 consecutive cycles of combination therapy, autologous HSCT,
immunomodulatory therapy, or radioimmunotherapy
c. For expansion part R/R MCL cohort:
i. Documented CD20+ MCL according to WHO classification (Swerdlow et al., 2016)
or WHO classification 2008 based on representative pathology report with either
cyclin D1 overexpression or presence of the translocation t(11;14).
ii. Stage II-IV with a need for treatment.
iii. Previously treated with at least 2 prior lines of systemic antineoplastic therapy
including at least 1 prior anti-CD20 mAb-containing regimen.
iv. Previously treated with a BTKi and either progressing (relapsed or refractory) or
intolerant to BTKi
v. Relapsed or refractory to the most recent line of therapy.
Note: Relapsed disease is defined as disease that has recurred ≥6 months after
completion of therapy. Refractory disease is defined as disease that either progressed
during therapy or progressed within 6 months (<6 months) of completion of therapy.
vi. Bridging therapy to reduce tumor burden should be considered for patients with
leukemic disease or high burden of disease due to likely increased risk of severe
CRS in these patients. Additional corticosteroid prophylaxis for CRS should also be
considered for such patients during the first cycle.
d. Criterion modified as per Amendment 8
d.1 Criterion modified as per Amendment 9
d.2 Criterion applies to optimization part subjects only: subjects must have
documented CD20+ DLBCL, NOS (de novo or transformed from FL) (for
DLBCL cohort), FL Grade 1, 2, or 3A (for FL cohort), or, only if cohort is
opened: MCL (for MCL cohort), according to WHO 2016 classification
3. Measurable disease:
a. Fluorodeoxyglucose (FDG)-avid lymphomas: Measurable disease with computerized
tomography (CT) (or magnetic resonance imaging [MRI]) scan with involvement of
2 or more clearly demarcated lesions/nodes with a long axis >1.5 cm and short axis
>1.0 cm (or 1 clearly demarcated lesion/node with a long axis >2.0 cm and short axis
≥1.0 cm) AND FDG positron emission tomography (PET) scan that demonstrates
positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites
b. FDG-nonavid lymphomas: Measurable disease with CT (or MRI) scan with
involvement of 2 or more clearly demarcated lesions/nodes with a long axis >1.5 cm
and short axis >1.0 cm or 1 clearly demarcated lesion/node with a long axis >2.0 cm
and short axis ≥1.0 cm.
4. Criterion modified as per Amendment 8
4.1 ECOG performance status 0, 1, or 2 (see Appendix 5). For MCL: ECOG PS <2
required for participation.
5. Criterion modified as per Amendment 9
5.1 Lymphocyte counts <5×109/L. For MCL subjects with leukemic disease: lymphocyte
counts <50×109/L at screening; however, lymphocyte counts must be reduced to below
<10×109/L before C1D1 (first epcoritamab dose administration) by any cytoreductive
treatment, including leukapheresis.
6. Platelet counts ≥75×109/L or, in the presence of bone marrow involvement or splenomegaly,
≥50×109/L
7. Absolute neutrophil counts ≥1.0×109/L; growth factor support allowed in case of bone marrow
involvement
8. Criterion modified as per Amendment 8
8.1 Patient must meet the following criteria regarding time since previous anti-neoplastic
agent(s):
a. At least 4 weeks from last dose of non-investigational systemic chemotherapy (except
when used as bridging therapy during screening in MCL cohort)
b. At least 4 weeks or 5 half-lives from last dose of other non-investigational
antineoplastic agents, whichever is shorter (except any anti-CD20 mAb or BTKi)
c. At least 5 half-lives from last dose of investigational agents except for prior chimeric
antigen receptor T-cell (CAR-T) therapy from which 30 days must pass prior to first epcoritamab administration.
9. Resolution of toxicities from prior therapy to a grade that does not contraindicate trial
participation in the opinion of the investigator
10. Criterion modified as per Amendment 8
10.1 If receiving glucocorticoid treatment at screening, must be a maximum daily dose of
prednisone 10 mg (or equivalent) and a total of no more than 140 mg over the last 14
days prior to the first dose of epcoritamab, unless for disease control
11. Before the first dose of epcoritamab, during the trial and for 12 months after last
administration of epcoritamab, a woman must be either:
a. Not of childbearing potential*: premenarchal; postmenopausal (>45 years of age with
amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months
and a serum follicle stimulating hormone [FSH] level >40 IU/L or mIU/mL);
permanently sterilized (e.g., bilateral tubal occlusion [which includes tubal ligation
procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy,
bilateral oophorectomy); or otherwise be incapable of pregnancy
b. Of childbearing potential and practicing a highly effective method of birth control (as
defined by the EU Clinical Trial Facilitation Group) consistent with local regulations
regarding the use of birth control methods for patients participating in clinical trials:
e.g., established use of oral, injected or implanted combined (estradiol and
progesterone containing) hormonal contraception; placement of an intrauterine device
(IUD) or intrauterine system (IUS); male partner sterilization (the vasectomized partner
should be the sole partner for that patient); true abstinence (when this is in line with the
preferred and usual lifestyle of the patient)
*If the childbearing potential changes after start of the trial (e.g., woman who is not
heterosexually active becomes active, premenarchal woman experiences menarche) a
woman must begin a highly effective method of birth control, as described under 31b.
12. A man who is sexually active with a woman of childbearing potential must agree to use a
barrier method of birth control (that is the use of condom) during the trial and for 12 months
after receiving the last dose of epcoritamab
13. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction
during the trial and for 12 months after receiving the last dose of epcoritamab. Men must also
not donate sperm during the trial and for 12 months after receiving the last dose of epcoritamab
14. The patient understands the purpose of the trial and procedures required for the trial and is
capable of giving signed informed consent as which includes compliance with the requirements
and restrictions listed in the informed consent form (ICF) and in this protocol
15. The patient must consent to provide sample(s) for evaluation of DNA.
16. Life expectancy >3 months on SOC treatment.
17. Access to intensive care management for treatment of CRS symptoms (ie, hypotension and/or
hypoxia), if required.
Ausschlusskriterien
1. Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at
screening as confirmed by mandatory magnetic resonance imaging (MRI)/computed
tomography (CT) scan (brain) and, if clinically indicated, by lumbar puncture.
2. Known past or current malignancy other than inclusion diagnosis, except for:
a. Cervical carcinoma of Stage 1B or less.
b. Non-invasive basal cell or squamous cell skin carcinoma.
c. Non-invasive, superficial bladder cancer.
d. Prostate cancer with a current PSA level <0.1 ng/mL.
e. Any curable cancer with a complete response (CR) of >2 years duration
3. AST, and/or ALT >3 × upper limit of normal
4. Total bilirubin >1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert’s
syndrome or of non-hepatic origin
5. Criterion modified as per Amendment 8
5.1 Estimated CrCl <45 mL/min (see Appendix 1)
6. Criterion modified as per Amendment 8
6.1 Criterion modified as per Amendment 9
6.2 Known clinically significant cardiovascular disease, including:
• Onset of unstable angina pectoris within 6 months of signing ICF
• Acute myocardial infarction within 6 months of signing ICF
• Congestive heart failure (grade III or IV as classified by the New York Heart
Association (see Appendix 2) and/or known decrease ejection fraction of <45%
• Stroke or intracranial hemorrhage within 6 months prior to signing ICF
• In case of any history of cardiovascular disease, a cardiology consult is required
within 60 days of enrollment.
• For patients who are =75 years old, 2 or more active cardiovascular diseases (any
type, = Grade 2) (MCL only)
7. Criterion modified as per Amendment 8
7.1 Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
requiring systemic treatment (excluding prophylactic treatment) at the time of
enrolment or within the previous 2 weeks prior to the first dose of epcoritamab,
including COVID-19 infection. Note that a past COVID-19 infection may be a risk
factor, but if resolved and the subject is vaccinated, it may be allowable to enroll the
subject
8. Confirmed history or current autoimmune disease or other diseases resulting in permanent
immunosuppression or requiring permanent immunosuppressive therapy. Low-dose (=10 mg/day) prednisolone (or equivalent) for rheumatoid arthritis or similar conditions is
allowed
9. Seizure disorder requiring therapy (such as steroids or anti-epileptics)
10. Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20
11. Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior
to first epcoritamab administration
12. Eligible for curative intensive salvage therapy followed by high dose chemotherapy with
HSCT rescue
13. Autologous HSCT within 100 days prior to first epcoritamab administration, or any prior
allogeneic HSCT or solid organ transplantation
14. Criterion modified as per Amendment 8
15. Criterion modified as per Amendment 8
15.1 Known human immunodeficiency virus (HIV) infection; HIV testing is required at
screening only if required per local health authorities or institutional standards.
16. Criterion modified as per Amendment 8
16.1 Exposed to live or live attenuated vaccine within 4 weeks prior to signing ICF;
Examples of live vaccines include, but are not limited to, the following: measles,
mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus
Calmette–Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are
generally killed virus vaccines and are allowed; however, intranasal influenza
vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
Experimental and/or non authorized SARS-CoV-2 vaccinations are not allowed.
17. Pregnancy or breast feeding
18. Criterion modified as per Amendment 8
18.1 Patient is known or suspected of not being able to comply with the study protocol (eg,
because of alcoholism, drug dependency, or psychological disorder) or has any
condition for which, in the opinion of the sponsor or investigator, participation would
not be in the best interest of the patient (e.g., could compromise their well-being) or
that could prevent, limit, or confound the protocol-specified assessments
19. Contraindication to all uric acid lowering agents
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
DLBCL - Diffuses großzelliges B-Zell-Lymphom
Medizinischer Befund
• Aggressive relapsed or refractory B-NHL (aNHL cohort) including:\n• Diffuse large B-cell lymphoma (DLBCL)\n• High grade B-cell lymphoma (HGBCL)\n• Primary mediastinal B-cell lymphoma (PMBCL)\n• Follicular lymphoma (FL) grade 3B\n• Indolent relapsed or refractory B-NHL (iNHL cohort) including:\n• FL grades 1-3A\n• Marginal zone lymphoma (MZL)\n• Small lymphocytic lymphoma (SLL)\n• Mantle cell lymphoma (MCL)
MedDRA Term
B-cell lymphoma refractory
OptiMATe
Optimizing MATRix as remission induction in PCNSL: De-escalated induction treatment in newly diagnosed primary CNS lymphoma - a randomized phase III trial
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
EudraCT-Nummer: 2018-002115-96
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OptiMATe
Studieninformationen
Studien-Code
UME-ID-9841
Studien-Akronym
OptiMATe
Studientitel
Optimizing MATRix as remission induction in PCNSL: De-escalated induction treatment in newly diagnosed primary CNS lymphoma - a randomized phase III trial
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022,2023,2024
EudraCT-Nummer: 2018-002115-96
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Alexander Röth

+49 (0)201 723-82530
alexander.roeth@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Klinikum Stuttgart

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
1. Immunkompetente Patienten und Patientinnen mit Erstdiagnose eines primären B-Zell- Lymphoms (DLBCL) des zentralen Nervensystems
2. Patienten und Patientinnen Alter 18-65 Jahre unabhängig vom ECOG oder 66-70 Jahre mit ECOG Performance Status ≤ 2
3. Histologisch oder zytologisch gesicherte Diagnose eines primären B-Zell-Lymphoms des zentralen Nervensystems durch den lokalen Pathologen. Diagnosensicherung mittels stereotaktischer oder offener Biopsie, Liquorzytologie oder Vitrektomie
4. Krankheit ausschließlich lokalisiert in ZNS, Liquor oder den Hirnnerven.
5. Mindestens eine messbare Läsion
6. Patienten ohne Vorbehandlung (eine bereits erfolgte oder noch andauernde Behandlung mit Steroiden ist erlaubt)
7. Unterzeichnung der Einwilligungserklärung entsprechend den internationalen Richtlinien und der nationalen Gesetzgebung durch den Patienten oder einen autorisierten gesetzlichen Vertreter – für den Fall, dass der Patient krankheitsbedingt nicht in der Lage dazu ist.
8. Die Fähigkeit, die Art der Studie und deren Inhalte zu verstehen
9. Sexuell aktive Patienten und Patientinnen im fortpflanzungs-fähigen Alter, die zugestimmt haben, während Ihrer gesamten Studienteilnahme adäquat zu verhüten
Ausschlusskriterien
1. Kongenitale oder erworbene Immunschwäche einschließlich HIV-Infektion und Organtranplantationen in der Vergangenheit.
2. Systemische Lymphom-Manifestation (außerhalb des ZNS)
3. Isoliertes okuläres Lymphom ohne Manifestation im Hirnparenchym oder im Rückenmark
4. Andere bösartige Erkrankungen; ausgenommen sind chirurgisch entfernte Karzinome in situ der Zervix, Karzinome der Haut und andere bösartige Tumoren, die sich seit mindestens 5 Jahren in kompletter Remission befinden.
5. Diagnostiziertes Non-Hodgkin Lymphom in der Vergangenheit
6. Inadäquate renale Funktion (Kreatinin-Clearance < 60 ml/min).
7. Inadequates Knochenmark, inadäquate kardiale Leistung, inadäquate Leber- oder Lungenfunktion gemäß Einschätzung Prüfer/Prüferin
8. Active hepatitis B or C Erkrankung.
9. Laufende Behandlung mit anderen Studienmedikamenten oder Teilnahme an einer klinischen Studie innerhalb der letzten 30 Tage vor Beginn dieser Studie.
10. Flüssigkeitsansammlung im 3. Raum > 500 ml.
11. Überempfindlichkeit gegenüber der Studienmedikation oder einen anderen Bestandteil der Behandlung.
12. Einnahme von Medikamenten, die mit großer Wahrscheinlichkeit zu Wechselwirkungen mit der Studienmedikation führen
13. Bekannter oder anhaltender Missbrauch von Arzneimitteln, Drogen oder Alkohol
14. Nicht geschäftsfähiger Patient ,der Art, Bedeutung und Konsequenzen der Studie nicht erfassen und verstehen kann und keinen gesetzlichen Betreuer hat.
15. Teilnahme an der Vorgängerstudie Matrix
16. Personen, die sich in einem Abhängigkeitsverhältnis zum Sponsor und/oder Prüfarzt/Prüfärztin befinden
17. Jeglicher familiärer, soziologischer oder geographischer Umstand, der potentiell die ordnungsgemäße protokollgerechte Durchführung der Studie und der Nachbeobachtung gefährdet
18. Bestehende oder geplante Schwangerschaft, Stillzeit
19. Geschlechtsreife Patienten, die sich weigern, für die Dauer der Studienteilnahme Verhütungsmittel zu verwenden: Intrauterinpassar; Hormonverhütung in Verbindung mit einer mechanischen Verhütungsmethode
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
ZNS - Lymphom mit Befall des zentralen Nervensystems
Medizinischer Befund
Primäres diffuses großes B-Zell-Lymphom (DLBCL) des zentralen Nervensystems ist eine seltene Erkrankung der zerebalen Parenchyma, Leptomeninges, der Augen oder des Rückenmarks. Sie macht 4-6% aller Non-Hodgkin Lymphome (NHL) und 3-4% aller primären Hirntumore aus. Die Inzidenz von PZNSL ist in den vergangenen 30 Jahren angestiegen vor allem bei immunkompeten Patienten. Die durchschnittliche Überlebensrate bei unbehandelten Patienten liegt bei 3 Monaten.
CML Ponderosa
Observational study on CML patients in any phase treated with ponatinib (Iclusig®) at any dose.
Berufsordnung (BO) / Interventionell, Multizentrisch
Dies ist eine multizentrische, prospektive und retrospektive, Kohorten‐Beobachtungsstudie mit CML Patienten in jeglicher Phase der Krankheit, die mit Ponatinib in Deutschland behandelt werden. Wie im Studiendesign und mit den Studienendpunkten festgelegt, handelt es sich um eine Beobachtungsstudie nach § 67 para. 6 AMG (AWB). Die Studie ist nicht‐interventionell; alle Behandlungsentscheidungen erfolgen nach dem Ermessen des behandelnden Arztes nach Indikation und…
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CML Ponderosa
Studieninformationen
Studien-Code
UME-ID-7442
Studien-Akronym
CML Ponderosa
Studientitel
Observational study on CML patients in any phase treated with ponatinib (Iclusig®) at any dose.
Kurzbeschreibung
Dies ist eine multizentrische, prospektive und retrospektive, Kohorten‐Beobachtungsstudie mit CML Patienten in jeglicher Phase der Krankheit, die mit Ponatinib in Deutschland behandelt werden. Wie im Studiendesign und mit den Studienendpunkten festgelegt, handelt es sich um eine Beobachtungsstudie nach § 67 para. 6 AMG (AWB). Die Studie ist nicht‐interventionell; alle Behandlungsentscheidungen erfolgen nach dem Ermessen des behandelnden Arztes nach Indikation und nicht nach dem Studiendesign oder Protokoll angeordnet. Die maximale Gesamtlaufzeit der Studie ist ca. 4 Jahre. Dies beinhaltet die Einschlussphase von ca. 24 Monaten und ein Minimum von 24 Monaten der Behandlung mit Ponatinib. Die Studie wird für ca. 2 Jahre fortgesetzt, nachdem der letzte Patient eingeschlossen wurde. Patienten mit unterschriebener Einverständniserklärung werden über die gesamte Dauer der Studie begleitet. Patienten, die die Behandlung unterbrechen, oder die Teilnahme aussetzen, werden bis 12 Monate nach Abbruch der Studie, der letzten Einnahme von Ponatinib oder bis zum Start einer neuen Krebstherapie begleitet. Alle Daten werden während der Studie in Verbindung mit den normalen Behandlungsterminen oder im Minimum aller 3 Monate gesammelt.
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2018,2019,2021
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Joachim Göthert

+49 (0)201 723-82530
joachim.goethert@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Universitätsklinikum Jena

Studiendesign
nicht-randomisiert, Multizentrisch, National
Einschlusskriterien
1. Adult patients (age ≥18 years) with CML in any phase who are initiating ponatinib monotherapy, or for whom ponatinib monotherapy was initiated after ponatinib approval in Germany. [The decision to prescribe ponatinib must have been made prior to enrolment in the study. Patients enrolled in the retrospective part of the study may or may not be still on ponatinib treatment at the time informed consent is given. These retrospective patients should have started treatment after 02.02.2015.].
2. Patients who have the ability to understand the requirements of the study, and provide written informed consent to comply with the study data collection procedures.
3. Patients with a minimum life expectancy of 3 months
Ausschlusskriterien
Patients are not eligible for participation in the study if they meet any of the following exclusion criteria:
1. Patients previously treated with investigational ponatinib (within a clinical trial)
2. Patients receiving an investigational agent
4. Patients who are pregnant and/or breastfeeding
5. Patients unable to sign the informed consent
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
CML - chronische myeloische Leukämie
Medizinischer Befund
Chronic Myeloid Leukemia, Chronic Phase
18-8367-BO
Langzeitverlauf neuroendokriner Neoplasien (NEN)
Berufsordnung (BO) / Nicht-interventionell
Zurück
18-8367-BO
Studieninformationen
Studien-Code
UME-ID-8367
Studien-Akronym
18-8367-BO
Studientitel
Langzeitverlauf neuroendokriner Neoplasien (NEN)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021
Beteiligte
Institute
Klinik für Endokrinologie, Diabetologie und Stoffwechsel, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Dr. med. Harald Lahner

harald.lahner@uk-essen.de

Hufelandstraße 55
45147 Essen

Studiendesign
Indikation
Solide Tumoren
Medizinischer Befund
NEN
18-8377-BO
Langzeitverlauf adrenocorticaler Karzinome (ACC)
Berufsordnung (BO) / Nicht-interventionell
Zurück
18-8377-BO
Studieninformationen
Studien-Code
UME-ID-8377
Studien-Akronym
18-8377-BO
Studientitel
Langzeitverlauf adrenocorticaler Karzinome (ACC)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021
Beteiligte
Institute
Klinik für Endokrinologie, Diabetologie und Stoffwechsel, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Dr. med. Harald Lahner

harald.lahner@uk-essen.de

Hufelandstraße 55
45147 Essen

Studiendesign
Indikation
Solide Tumoren
Medizinischer Befund
adrenocorticaler Karzinome (ACC)
EORTC QLQ-THY34
Eine internationale Phase IV Studie bezüglich der Zuverlässigkeit und Gültigkeit eines EORTC-Fragebogens zur Messung der Lebensqualität bei Patienten mit Schilddrüsenkarzinom (EORTC QLQ-THY, Phase IV)
Berufsordnung (BO) / Nicht-interventionell, Multizentrisch
Zurück
EORTC QLQ-THY34
Studieninformationen
Studien-Code
UME-ID-8211
Studien-Akronym
EORTC QLQ-THY34
Studientitel
Eine internationale Phase IV Studie bezüglich der Zuverlässigkeit und Gültigkeit eines EORTC-Fragebogens zur Messung der Lebensqualität bei Patienten mit Schilddrüsenkarzinom (EORTC QLQ-THY, Phase IV)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2019,2021
Beteiligte
Institute
Klinik für Endokrinologie, Diabetologie und Stoffwechsel, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. Dr. Dagmar Führer-Sakel

Dagmar.Fuehrer-Sakel@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

EORTC, Berlin

Studiendesign
Andere nicht-interventionelle Studie, Multizentrisch, International
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Solide Tumoren
Medizinischer Befund
Schildrüsen-CA
Novartis CJDQ443A12101
A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
EudraCT-Nummer: 2020-004129-22
Zurück
Novartis CJDQ443A12101
Studieninformationen
Studien-Code
UME-ID-9896
Studien-Akronym
Novartis CJDQ443A12101
Studientitel
A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022,2023,2024
EudraCT-Nummer: 2020-004129-22
Beteiligte
Institute
Innere Klinik (Tumorforschung), Ruhrlandklinik - Thorakale Onkologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Schuler

martin.schuler@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Novartis Pharma Schweiz AG

+41 41 763 71 11

Suurstoffi 14
6343 Rotkreuz

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
Dose Escalation:
• Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care therapy or are intolerant or ineligible to approved therapies.
Dose Expansion:
• Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who are in the second or third line treatment setting and who have received a platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy
• Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who are in the third or fourth line treatment setting and have received a platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy, followed by one treatment line of a direct KRAS G12C inhibitor given as a single agent and discontinued within 6 months of the first day of study treatment.
• Patients with advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer who have received standard-of-care therapy, including a fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless patient was ineligible to such therapy.
All Patients:
• ECOG performance status of 0 or 1.
• Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the institution’s own guidelines and requirements for such procedures.
Ausschlusskriterien
• Tumors harboring driver mutations that have approved therapies or tumors with known activating KRAS, NRAS, HRAS, BRAF, or PTPN11 (SHP2) mutations, with the exception of KRAS G12C mutations.
• Prior treatment with a KRAS G12C inhibitor is excluded for patients in the single agent dose escalation arm and a subset of groups in dose expansion.
• Prior treatment with a SHP2 or SOS1 inhibitor is not allowed for NSCLC patients enrolled into the dose expansion parts of the JDQ443 single agent and JDQ443 plus TNO155 expansion arms.
• Active brain metastases, i.e. symptomatic brain metastases or known leptomeningeal disease
• Clinically significant cardiac disease or risk factors at screening
• Insufficient bone marrow, hepatic or renal function at screening
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Multientity/Biomarker driven
Medizinischer Befund
advanced solid tumors harboring the KRAS G12C mutation
MedDRA Term
Malignant solid tumor, Non-small cell lung cancer, Colorectal cancer, KRAS mutation
INCMOR 0208-301
Eine randomisierte, doppelblinde, placebokontrollierte, multizentrische Phase-III-Studie zur Beurteilung der Wirksamkeit und Sicherheit von Tafasitamab plus Lenalidomid zusätzlich zu Rituximab im Vergleich zu Lenalidomid zusätzlich zu Rituximab bei Patienten mit rezidiviertem/refraktärem (R/R) follikulärem Lymphom Grad 1 bis 3a oder R/R Marginalzonenlymphom
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
EudraCT-Nummer: 2020-004407-13
Zurück
INCMOR 0208-301
Studieninformationen
Studien-Code
UME-ID-10035
Studien-Akronym
INCMOR 0208-301
Studientitel
Eine randomisierte, doppelblinde, placebokontrollierte, multizentrische Phase-III-Studie zur Beurteilung der Wirksamkeit und Sicherheit von Tafasitamab plus Lenalidomid zusätzlich zu Rituximab im Vergleich zu Lenalidomid zusätzlich zu Rituximab bei Patienten mit rezidiviertem/refraktärem (R/R) follikulärem Lymphom Grad 1 bis 3a oder R/R Marginalzonenlymphom
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2022,2023
EudraCT-Nummer: 2020-004407-13
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Dr. med. Julia von Tresckow

+49 (0)201 723-82530
julia.vontresckow@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Incyte Corporation, DE, USA

Studiendesign
Multizentrisch
Einschlusskriterien
1. Age ≥ 18 years. For Japan, aged 20 years or older at the time of signing the ICF.
2. Ability to comprehend and willingness to sign a written ICF for the study.
3. Histologically confirmed Grade 1, 2, or 3a FL or histologically confirmed nodal MZL, splenic MZL, or extranodal MZL (CD19+ and CD20+ by flow cytometry or immunohistochemistry) as assessed locally (Swerdlow et al 2016).
Note: Participants with gastric MZL and evidence of Helicobacter pylori must have a documented nonresponse to antibiotic therapy.
4. Willingness to avoid pregnancy or fathering children based on the criteria below.
a. Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 180 days (6 months) after the last dose of study treatment, even if they have undergone a successful vasectomy, and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix A) should be communicated to the participants and their understanding confirmed.
b. WOCBP participants:
− Must commit either to abstain continuously from heterosexual sexual intercourse or agree to take appropriate precautions to avoid pregnancy (by using 2 different methods of birth control: one with at least 99% certainty and an additional effective [barrier] method) starting at least 4 weeks before taking the study treatment, while taking the study treatment, during breaks (dose interruptions), and for at least 180 days (6 months) after stopping the study treatment. Permitted methods that are at least 99% effective in preventing pregnancy and the permitted additional effective (barrier) methods (see Appendix A) should be communicated to the participants and their understanding confirmed.
Note: Because of the increased risk of venous thromboembolism, combined oral contraceptive pills are not recommended. If a participant is currently using combined oral contraception, the participant should switch to one of the effective methods listed in Appendix A. The risk of venous thromboembolism continues for 4 to 6 weeks after discontinuing combined oral contraception.
− Must have a negative serum pregnancy test at screening (within 10-14 days of the first study drug treatment) and before the first dose on Day 1 (within 24 hours of initiating treatment with lenalidomide).
− Agree to ongoing pregnancy testing during the course of the study; weekly during the first month of study drug treatment, then monthly thereafter for women with regular menstrual cycles or every 2 weeks for women with irregular menstrual cycles (even if true abstinence is the chosen method of birth control) up to and including the EOT visit.
− Must refrain from breastfeeding and donating oocytes during the course of study and for 180 days (6 months) after the last dose of study treatment.
c. A woman not considered to be of childbearing potential as defined in Appendix A is
eligible.
Note: The participants should be informed about the option of donation and cryopreservation of germ cells before the study if applicable.
5. All participants must:
a. Have an understanding that lenalidomide could have a potential teratogenic risk.
b. Abstain from donating blood while taking study treatment and for 28 days after discontinuation of study treatment.
c. Not share study medication with another person.
d. Agree to be counseled about pregnancy precautions and risk of fetal exposure.
e. In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin). Participants unable or unwilling to take any prophylaxis are not eligible.
f. In the opinion of the investigator, be able to understand and comply with all study-related procedures, medication use, and evaluations.
g. In the opinion of the investigator, not have a history of noncompliance or be considered potentially unreliable and/or uncooperative.
6. Tumor tissue sufficient for retrospective central pathology review and correlative studies must be provided to participate in this study. A fresh biopsy is preferred if clinically feasible but if not, an archival specimen is acceptable (refer to the Laboratory Manual).
Note: a fresh biopsy must be performed if the relapse is within 24 months from the initial diagnosis (POD24) to exclude transformed cases and potentially misdiagnosed cases.
7. Must have been previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy. This includes treatments such as the following: rituximab monotherapy or chemotherapy plus immunotherapy with rituximab or obinutuzumab, with or without maintenance. Note: At least 4 doses of anti-CD20 immunotherapy must have been given in prior therapy. Note: Systemic therapy does not include, for example, local involved field radiotherapy for limited stage disease, HBV/HCV therapy, or H pylori eradication.
8. Must have documented relapsed, refractory, or PD after treatment with systemic therapy (a participant in remission [in CR or PR] after the last prior treatment line would not be
eligible).
a. Relapsed lymphoma: relapsed after initial response of CR to prior therapy.
b. Refractory lymphoma: achieved less than PR to the last treatment or achieved a CR or PR that lasted less than 6 months before lymphoma progression.
c. Progressive lymphoma: PD after initial response of PR or SD to prior therapy.
9. Must be in need of treatment for relapsed, refractory, or PD as assessed by the investigator. Refer to GELF criteria (see Appendix G) as a guidance for participants with FL only.
10. Participants must have at least 1 measurable disease site. A radiographically measurable lymphadenopathy is defined as at least 1 nodal lesion > 1.5 cm in longest diameter or at least 1 extranodal lesion > 1.0 cm in longest diameter (Cheson et al 2014). The lesion must be confirmed to be measurable by CT and/or PET (for participants with PET-positive lesions) at the latest at the time of randomization.
Note: Participants with PET-negative lesions that are measureable by CT are eligible and followed-up with CT only as described in Section 8.2.3.
11. ECOG performance status of 0 to 2.
12. Participants with laboratory values at screening defined in Table 6.
Ausschlusskriterien
Participants are excluded from the study if any of the following criteria apply:
1. Women who are pregnant or breastfeeding. For Japan, women who are breastfeeding and wish to enroll must discontinue breastfeeding at least 90 days before receiving study drug/treatment. They must also refrain from breastfeeding during the course of study and for 90 days after the last dose of study treatment.
2. Any histology other than FL and MZL or clinical evidence of transformed lymphoma by INV assessment.
3. History of radiation therapy to = 25% of the BM for other diseases.
4. History of prior nonhematologic malignancy except for the following:
a. Malignancy treated with curative intent and with no evidence of active disease for more than 2 years before screening.
b. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer.
c. Adequately treated carcinoma in situ without current evidence of disease.
5. Congestive heart failure (left ventricular ejection fraction of < 50%, assessed by 2D-echocardiography or MUGA scan.
6. Participants with:
a. Known positive test result for HCV (with anti-HCV serology testing) and a positive test for HCV RNA.
Note: Participants with positive serology must have been tested for HCV RNA and are eligible only in the case of negative HCV RNA.
b. Known positive test result for chronic HBV infection (defined by HBsAg positivity).
Note: Participants with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA was undetectable, provided that they are willing to undergo monthly ongoing DNA testing. Antiviral prophylaxis may be administered as per institutional guidelines. Participants who have protective titers of HBsAb (HBsAb positive, HBcAb negative, and HBsAg negative) after vaccination or previously cured hepatitis B are eligible.
c. Seropositivity for or history of active viral infection with human immunodeficiency virus.
7. Active systemic infection (including SARS-CoV-2–positive test).
8. Participants in a severely immunocompromised state.
9. Known CNS lymphoma involvement.
10. Uncontrolled intercurrent illness.
11. History or evidence of clinically significant cardiovascular, CNS, and/or other systemic disease that would, in the investigator's opinion, preclude participation in the study or compromise the participant's ability to give informed consent.
12. Life expectancy < 6 months.
13. History or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
14. Major surgery (excluding lymph node biopsy) within 28 days prior to signing the ICF unless the participant is recovered at the time of signing the ICF.
15. Any systemic antilymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1.
16. Administration of a live vaccine within 28 days prior to the start of study treatment (Cycle 1 Day 1).
17. Prior use of lenalidomide in combination with rituximab.
18. History of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, immunomodulatory drugs, rituximab, other mAbs, and/or the excipients contained in the study drug formulations.
19. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
NHL ind. - indolentes Non-Hodgkin Lymphom
Medizinischer Befund
follikuläres Lymphom \nMarginalzonenlymphom
MedDRA Term
In situ follicular lymphoma, Marginal zone lymphoma
SIOPEATRT01
An international prospective umbrella trial for children with atypical teratoid/rhabdoid tumours (ATRT) including A randomized phase III study evaluating the non-inferiority of three courses of high-dose chemotherapy (HDCT) compared to focal radiotherapy as consolidation therapy
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
EudraCT-Nummer: 2018-003335-29
Zurück
SIOPEATRT01
Studieninformationen
Studien-Code
UME-ID-9730
Studien-Akronym
SIOPEATRT01
Studientitel
An international prospective umbrella trial for children with atypical teratoid/rhabdoid tumours (ATRT) including A randomized phase III study evaluating the non-inferiority of three courses of high-dose chemotherapy (HDCT) compared to focal radiotherapy as consolidation therapy
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022,2023
EudraCT-Nummer: 2018-003335-29
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Dr. Stephan Tippelt

2768
stephan.tippelt@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

German Pediatric Oncology Group, GPOH gGmbH, Berlin

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
Registration Into Umbrella Trial
- Age at diagnosis less than 18 years
- Pathology compatible with ATRT and INI1 loss or SMARCB1 or SMARCA4 deficiency confirmed by local pathology lab
- Written informed consent and/or assent for study participation according to national legislation
- Patient agrees to use effective contraception whilst on treatment (patients of childbearing potential)

Part A:
1 Enrolled in the umbrella trial
2. Received 3 courses of induction chemotherapy according to the protocol and following induction in SD or better
3. Expected age 12-35 months at time of consolidation therapy (RT or HDCT)
4. Written informed consent and/or assent for randomization according to national legislation
5. Central review of pathology confirmed ATRT
6. MRI and CSF examination after 3 courses of chemotherapy and, if applicable, later showing SD or better (central review – national or regional centre)
7. ALT or AST ≤3.0 x ULN, bilirubin ≤ 1.5 x ULN
8. Creatinine ≤ 1.5 x ULN and measured GFR within published defined age-related values according to national standard methods.
9. EF ≥50% or FS ≥29% by echocardiography.

Part B:
1. Enrolled in the umbrella trial
2. Received 3 courses of induction chemotherapy according to the protocol
3. Radiotherapy not admissible (e.g. <12 months or other contraindications)
4. Not eligible for the randomized trial (Part A) (e.g. refusal of randomization)
5. Written informed consent and/or assent for inclusion according to national legislation
6. Central review of pathology confirmed ATRT
7. MRI and CSF examination after 3 courses of chemotherapy and, if applicable, later showing clinically significant sensitivity to chemotherapy (central review – national or regional centre)
8. ALT or AST ≤3.0 x ULN, bilirubin ≤ 1.5 x ULN
9. Creatinine ≤ 1.5 x ULN and measured GFR within published defined age-related values according to national standard methods.
10. EF ≥50% or FS ≥29% by echocardiography.

Part C:
1. Enrolled in the umbrella trial
2. Received 3 courses of induction chemotherapy according to the protocol
3. Aged 36 months or above OR
4. HDCT not possible OR
5. Not eligible for the randomized trial (Part A)
6. Written informed consent and/or assent for inclusion according to national legislation
7. Central review of pathology confirmed ATRT
8. MRI and CSF examination after 3 courses of chemotherapy and, if applicable, later showing SD or better (central review – national or regional centre)
9. ALT or AST ≤3.0 x ULN, bilirubin ≤ 1.5 x ULN
10. Creatinine ≤ 1.5 x ULN and measured GFR within published defined age-related values according to national standard methods.
11. EF ≥50% or FS ≥29% by echocardiography
Ausschlusskriterien
Part A:
1. Previous or concomitant tumour directed chemotherapy, RT or small molecule therapy, other than within the SIOPE ATRT01 trial
2. Metastatic disease at primary diagnosis
3. At time of inclusion Diarrhoea grade 3 or worse according to the CTCAE v5.0, if uncontrolled despite optimal supportive therapy
4. History or presence of clinically significant cardiac disease, including, but not limited to, any of the following, if uncontrolled despite optimal supportive care:
a. Sustained ventricular tachyarrhythmia
b. Any ventricular fibrillation or torsade de pointes,
5. At time of inclusion bradycardia defined as persistent heart rate 450msec minute if uncontrolled despite optimal supportive therapy
6. Pulmonary hypertension as diagnosed by a paediatric cardiologist with indirect (echocardiography) or direct signs (pulmonary artery pressure =25mmHg)
7. Any contraindication to any planned chemotherapy drug according to SmPC
8. Known active HBV, HCV or HIV infection
9. Participation in another interventional therapeutic clinical trial
10. Patients on coumarin-derivative anticoagulants
11. History of thrombosis or SOS
12. Any ongoing, uncontrolled, clinically significant infection (viral, bacterial or fungal)
13. Neutropenia (ANC <0.5 x109/L) lasting 6 weeks from the start of the previous course of chemotherapy
14. Synchronous multifocal rhabdoid tumours
15. Hypersensitivity to the active compounds or other

Part B:
1. Previous or concomitant tumour directed chemotherapy, radiotherapy or small molecule therapy, other than within the SIOPE ATRT01 trial
2. At time of inclusion Diarrhoea grade 3 or worse according to the CTCAE v5.0, if uncontrolled despite optimal supportive therapy
3. History or presence of clinically significant cardiac disease, including, but not limited to, any of the following, if uncontrolled despite optimal supportive therapy:
a. Sustained ventricular tachyarrhythmia
b. Any ventricular fibrillation or torsade de pointes
c. Current bradycardia defined as heart rate < 50/minute
d. Screening ECG with a QTcB >450msec
4. Pulmonary hypertension as diagnosed by a paediatric cardiologist with indirect (echocardiography) or direct signs (pulmonary artery pressure =25mmHg)
5. Any contraindication to any planned chemotherapy drug according to SmPC
6. Known active HBV, HCV or HIV infection
7. Participation in another interventional therapeutic clinical trial
8. Patients on coumarin-derivative anticoagulants
9. History of thrombosis or SOS
10. Any ongoing, uncontrolled, clinically significant infection (viral, bacterial or fungal)
11. Neutropenia (ANC <0.5 x109/L) lasting 6 weeks from the start of the previous course of chemotherapy
12. Hypersensitivity to the active substance or other excipients contained in one of the investigational medical products listed in the SmPC.

Part C:
1. Previous or concomitant tumour directed chemotherapy, RT or small molecule therapy, other than within the SIOPE ATRT01 trial
2. Any contraindication to any planned chemotherapy drug according to SmPC
3. Participation in another interventional therapeutic clinical trial
4. Any ongoing, uncontrolled, clinically significant infection (viral, bacterial or fungal)
5. Hypersensitivity to the active substance or other excipients contained in one of the investigational medical products listed in the SmPC.
Studienteilnehmende Mindestalter
0 Tag(e)
Studienteilnehmende Höchstalter
11 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
atypical teratoid\/rhabdoid tumours (ATRT)
Reduct
Webbasierte Achtsamkeits- und Skills- basierte Belastungsreduktion für Patientinnen und Patienten mit Krebs: Eine multizentrische, randomisierte, kontrollierte Interventionsstudie (Reduct)
Berufsordnung (BO) / Interventionell, Multizentrisch
Zurück
Reduct
Studieninformationen
Studien-Code
UME-ID-10078
Studien-Akronym
Reduct
Studientitel
Webbasierte Achtsamkeits- und Skills- basierte Belastungsreduktion für Patientinnen und Patienten mit Krebs: Eine multizentrische, randomisierte, kontrollierte Interventionsstudie (Reduct)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021
Beteiligte
Institute
LVR Kliniken-Essen - Klinik für Psychosomatische Medizin und Psychotherapie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Dr. Alexander Bäuerle

+49 (0)201 7227-203
Alexander.Baeuerle@uni-due.de

Virchowstraße 174
45147 Essen

Studiendesign
randomisiert, kontrolliert, Multizentrisch
Einschlusskriterien
Alter zwischen 18 und 65 Jahren
- Ausreichende Deutschkenntnisse
- aktuell oder in den letzten 12 Monaten eine Krebserkrankung
- Bereitschaft, sich einer der Gruppen randomisiert (=zufällig) zuteilen zu lassen und an der Interventions- oder Kontrollgruppe teilzunehmen
- Internetverbindung und ein internetfähiges Gerät
Studienteilnehmende Mindestalter
18 Jahr(e)
Studienteilnehmende Höchstalter
65 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Diverse
Medizinischer Befund
Webbasierte Achtsamkeits- und Skills- basierte Belastungsreduktion für Patientinnen und Patienten mit Krebs
COMBATBIL
A phase Ib/II single-arm study evaluating the safety and efficacy of combined immunotherapy with mFOLFOX6, bevacizumab and atezolizumab in advanced-stage biliary tract cancer
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
EudraCT-Nummer: 2018-000257-45
Zurück
COMBATBIL
Studieninformationen
Studien-Code
UME-ID-9966
Studien-Akronym
COMBATBIL
Studientitel
A phase Ib/II single-arm study evaluating the safety and efficacy of combined immunotherapy with mFOLFOX6, bevacizumab and atezolizumab in advanced-stage biliary tract cancer
Aktueller Studienstatus
Aktiv, nicht rekrutierend
Studie aktiv in den Jahren
2021,2022,2023
EudraCT-Nummer: 2018-000257-45
Beteiligte
Institute
Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Jens Siveke

jens.siveke@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Universitätsklinik Essen (AöR)

+49 (0)201 723-0
info@uk-essen.de

Hufelandstraße 55
45147 Essen

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch, International
Einschlusskriterien
Subjects must fulfill all of the following criteria for study entry:
1) Signed informed consent form
2) Age ≥ 18 years by the time of inclusion in the study
3) Ability to comply with the study protocol, in the investigator’s judgment
4) Histologically confirmed advanced BTC
5) Patient must have received at least one prior line of systemic therapy in advanced-stage BTC
6) Adjuvant or neoadjuvant chemotherapy is allowed, provid it is completed at least 6 months before start of study treatment
7) Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
8) Life expectancy > 12 weeks
9) Measurable disease, according to RECIST v1.1. Lesions intended to be biopsied should not be defined as target lesions
10) Tumor must be accessible for biopsies and patient willing to provide tissue from a newly obtained biopsy of a tumor lesion
11) Adequate hematologic and end-organ function
12) For women of childbearing potential: Negative serum pregnancy test within 21 days prior to Cycle 1 Day 1 (C1D1). Agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraceptive methods that result in a failure rate of ≤ 1% per year during the treatment period and for at least 180 days after the last study treatment
13) For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined below:
o With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 180 days after the last dose of study treatment. Men must refrain from donating sperm during this same period.
Ausschlusskriterien
1) Malignancies other than BTC within 3 years prior to C1D1 with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year overall survival > 90%) treated with expected curative outcome
2) Patients with known microsatellite instability high (MSI-H) status.
3) Untreated central nervous system (CNS) metastases. Treatment of brain metastases, either by surgical or radiation techniques must have been completed at least 4 weeks prior to initiation of study treatment.
4) Radiation therapy within 21 days prior to C1D1 and/or persistence of radiation-related adverse effects
5) Prior allogeneic bone marrow transplantation or solid organ transplant for another malignancy in the past
6) Spinal cord compression not definitively treated with surgery and/or radiation
7) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
8) Uncontrolled tumor pain. Patients who require narcotic pain medication during screening should be on a stable dose regimen prior to C1D1. Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth should be considered for loco-regional therapy if appropriate prior to enrollment.
9) Treatment with any investigational agent or approved therapy within 28 days or two investigational agent half-lives (whichever is longer) prior to C1D1
10) Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-PD-1 and anti-PD-L1, or VEGF/VEGFR inhibitors
11) Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5-fluorouracil (5-FU) toxicity
12) History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
13) Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any components of atezolizumab or bevacizumab formulations
14) Current or recent (within 10 days of study enrollment) use of acetylsalicylic acid (> 325 mg/day), clopidogrel (> 75 mg/day) or thrombolytic agents for therapeutic purposes
15) History of clinically significant cardiac or pulmonary dysfunction.
16) History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
17) Major surgical procedure within 4 weeks prior to C1D1 or anticipation of need for a major surgical procedure during the course of the study
18) Evidence of tumor invading or abutting major blood vessels
19) Serious non-healing wound, active ulcer or untreated bone fracture
20) History of abdominal fistula or gastrointestinal perforation within 6 months prior to C1D1
21) History of hemoptysis (= ½ teaspoon of bright red blood per episode), or any other serious hemorrhage, or at risk of bleeding
22) INR > 1.5 and aPTT > 1.5 x ULN within 7 days prior to C1D1 (excluding patients on prophylactic or therapeutic anticoagulation)
23) History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding
24) Proteinuria at screening as demonstrated by urine dipstick = 2+ or 24-hour proteinuria > 1.0 g
25) Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
26) Systemic immunostimulatory agents are prohibited within 4 weeks or five half-lives of the drug (whichever is longer) prior to C1D1
27) Autoimmune conditions: History of autoimmune disease
28) Infectious diseases
o Severe infection within 4 weeks prior to initiation of C1D1
o Treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to initiation of study treatment
o Patients with active hepatitis B
o Patients with past hepatitis B virus (HBV) infection or resolved HBV infection are eligible. HBV DNA test must be performed in these patients prior to C1D1.
o Patients with active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
o Positive HIV test at screening or at any time prior to screening
o Known active tuberculosis
o Patients must not receive any kind of living, attenuated vaccine (e.g. Fluenz® Tetra) within 4 weeks prior to C1D1 or at any time during the study and for at least 5 months after the last dose of study drug.
29) Pregnant or lactating or intending to become pregnant during the study or within 5 months after final dose for atezolizumab or 6 months for bevacizumab.
30) Uncontrolled serious medical or psychiatric illness
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Urogenitale Tumore
Medizinischer Befund
advanced-stage biliary tract cancer
MedDRA Term
Cholangiocarcinoma
M-2020-371 - DALY 2
A pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL), who are not eligible for high-dose chemotherapy and autologous stem cell transplantation
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
A study to evaluate efficacy and safety of MB-CART2019.1 compared with usual medication for patients with diffuse large B-cell lymphoma
EudraCT-Nummer: 2020-003908-14
Zurück
M-2020-371 - DALY 2
Studieninformationen
Studien-Code
UME-ID-9924
Studien-Akronym
M-2020-371 - DALY 2
Studientitel
A pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL), who are not eligible for high-dose chemotherapy and autologous stem cell transplantation
Kurzbeschreibung
A study to evaluate efficacy and safety of MB-CART2019.1 compared with usual medication for patients with diffuse large B-cell lymphoma
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022,2023,2024
EudraCT-Nummer: 2020-003908-14
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Bastian von Tresckow

+49 (0)201 723-82530
bastian.vontresckow@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Miltenyi Biomedicine GmbH, Bergisch Gladbach

Studiendesign
randomisiert, kontrolliert, Multizentrisch
Einschlusskriterien
1. Histologically proven DLBCL and associated subtypes, according to the World Health Organisation (WHO) 2016 classification including:
• DLBCL not otherwise specified (NOS).
• High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double hit lymphoma/triple hit lymphoma).
• High-grade BCL, NOS.
• Primary (thymic) large mediastinal BCL.
• Disease transformed from an earlier diagnosis of low-grade lymphoma (e.g. an indolent pathology such as follicular lymphoma, marginal zone lymphoma) into DLBCL with DLBCL disease progression subsequent to DLBCL directed systemic treatment.
2. Relapsed or refractory disease after first-line chemoimmunotherapy:
• Refractory disease is defined as no CR to first-line therapy.
- PD as best response after at least 4 full cycles of R-CHOP (rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin and prednisone) cycles as first-line therapy.
- Stable disease (SD) after 6 R-CHOP cycles as first-line therapy.
- PR as best response after at least 6 R-CHOP cycles and biopsy-proven disease progression (except where prohibited due to comorbidities) within ≤ 12 months from the completion of the first-line therapy.
• Relapsed disease defined as complete remission to a first-line therapy followed by biopsy-proven disease progression (except where prohibited due to comorbidities) within ≤ 12 months from the completion of the first-line therapy.
3. Participants must have received adequate first-line therapy containing at least the combination of an anthracycline-based regimen and rituximab (anti-CD20 monoclonal antibody). Local therapies (e.g. radiotherapies) will not be considered as line of therapy if performed during the same line of treatment.
4. Archival paraffin-embedded tumour tissue acquired ≤ 3 years prior to screening for central pathology review to confirm DLBCL diagnosis and for analysis of CD20/CD19 expression must be made available for participation in this study. If archival paraffin-embedded tumour tissue is not available, fresh tumour tissue sample (preferred) or core-needle biopsy for this protocol must be made available.
5. Participants deemed ineligible to receive HDC followed by ASCT based on the treating physician’s assessment and meeting the following criteria:
• Age ≥ 18 years and
- Prior ASCT (as first-line consolidation) or
- Haematopoietic Cell Transplantation-specific Comorbidity Index (HCT-CI) > 3.
• Age ≥ 65 years and 1 of the criteria below:
- Prior ASCT (as first-line consolidation), or
- Comorbidities as assessed by an HCT-CI score > 3, or
- Impaired cardiac function (left ventricular ejection fraction (LVEF) < 50%), or
- Impaired renal function (creatinine clearance [CrCl] < 60 mL/min) as determined by the MDRD (Modification of Diet in Renal Disease) formular, or
- Impaired pulmonary function (diffusing capacity for carbon monoxide or forced expiratory volume in 1 second of 66% to 80%) or dyspnoea on slight activity, or
- Eastern Cooperative Oncology Group (ECOG) performance status > 1.
Documentation of the reason for ineligibility for ASCT must be present in the participant’s source data.
In addition, all participants must fulfil the following criteria:
6. Age ≥ 18 years.
7. Measurable disease according to Lugano criteria. The lesion must be positive on a positron emission tomography scan.
8. Estimated life expectancy of > 3 months for other reasons than the primary disease.
9. Woman of childbearing potential (WOCBP) must agree to use highly effective contraceptive measures (Pearl index < 1) or practice true sexual abstinence from any heterosexual intercourse (True abstinence is only acceptable if it is in line with the preferred and usual life style of the participant.) or must have a vasectomised partner as the sole sexual partner (The vasectomised partner must have received medical assessment of the surgical success.) for at least 1 month before the study start, during the study and in the 12 months following the last dose of study treatment. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Highly effective methods of contraception include hormonal contraceptives (oral, intravaginal, transdermal, injectable, implantable) and intrauterine devices or systems (e.g. hormonal and non-hormonal) and bilateral tubal occlusion. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. WOCBP must refrain from egg donation throughout the study until 12 months after the last dose of study treatment. WOCBP must refrain from egg donation throughout the study until 12 months after the last dose of study treatment.

FOR FULL LIST OF INCLUSION CRITERIA PLEASE REFER TO THE STUDY PROTOCOL
Ausschlusskriterien
1. Contraindications for R-GemOx and BR plus polatuzumab vedotin as judged by the treating physician.
2. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.
3. ECOG performance status > 2.
4. Absolute neutrophil count < 1,000/µL (unless secondary to bone marrow involvement by DLBCL as demonstrated by bone marrow biopsy required for screening).
5. Platelet count < 50,000/µL (unless secondary to bone marrow involvement by DLBCL as demonstrated by bone marrow biopsy required for screening).
6. Absolute lymphocyte count < 100/µL.
7. Participants who have CNS lymphoma involvement in present or past medical history.
8. Known history of infection with human immunodeficiency virus or active infection with hepatitis B (hepatitis B surface antigen positive).
9. Known history of infection with hepatitis C virus unless treated and confirmed to be polymerase chain reaction negative.
10. Active infection with SARS-CoV-2.
11. Known history or evidence of severely immunocompromised state; i.e. corticosteroid treatment > 10 mg/day for more than 6 months.
12. Has received vaccination with live virus vaccines within 6 weeks prior to randomisation.
13. Prior CD19 targeted therapy
14. Known history or presence of seizure activities or on active antiseizure medications within the previous 12 months.
15. Presence of CNS disease that, in the judgement of the investigator, may impair the ability to evaluate neurotoxicity.
16. Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease.
17. Known history or presence of cerebral vascular accident (CVA) within 12 months prior to randomisation. Note: In case of history of CVA > 12 months prior to leukapheresis, then the participant must not have any unstable or life-threatening neurological deficits.
18. Participants with Richter's transformation or Richter's syndrome.
19. Participants who are concurrently on any other experimental treatments or during the previous 4 weeks or 5-half-lives.
20. Clinical heart failure with New York Heart Association class = 2 or LVEF < 30%.
21. Resting peripheral oxygen saturation < 90% on room air.
22. Liver dysfunction as indicated by total bilirubin, aspartate aminotransferase and/or alanine aminotransferase > 5 × institutional upper limit of normal (ULN)
23. Serum creatinine = 2.0 × ULN or CrCl < 30 mL/min calculated according to the modified formula of MDRD.
24. Pregnant or breast-feeding woman.
25. Prior history of malignancies other than DLBCL, unless the participant has been free of the disease for = 3 years prior to screening. Exceptions to the = 3-year time limit include history of the following:
• Basal cell carcinoma of the skin.
• Squamous cell carcinoma of the skin.
• Carcinoma in situ of the cervix.
• Carcinoma in situ of the breast.
• Carcinoma in situ of the bladder.
• Incidental histological finding of untreated localized (T1a or T1b) prostate cancer under surveillance .
26. History of severe immediate hypersensitivity reaction against any drug or its ingredients/impurities that is scheduled to be given during study participation e.g. as part of the mandatory lymphodepletion protocol, premedication for infusion, or rescue medication/salvage therapies for treatment-related toxicities.
27. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
DLBCL - Diffuses großzelliges B-Zell-Lymphom
Medizinischer Befund
Relapsed\/refractory diffuse large B cell lymphoma (R-R DLBCL)
MedDRA Term
B-cell lymphoma refractory, B-cell lymphoma recurrent
CLL16
A PROSPECTIVE, OPEN-LABEL, MULTICENTER, RANDOMIZED, PHASE 3 TRIAL OF ACALABRUTINIB, OBINUTUZUMAB AND VENETOCLAX (GAVE) COMPARED TO OBINUTUZUMAB AND VENETOCLAX (GVE) IN PREVIOUSLY UNTREATED PATIENTS WITH HIGH RISK (17P-DELETION, TP53- MUTATION OR COMPLEX KARYOTYPE) CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
This multicenter, prospective, open-label, randomized, superiority phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the progression-free survival (PFS) as compared to treatment with the combination of obinutuzumab and venetoclax (GVe) in patients with high risk CLL (defined as having at least one of the following risk factors: 17pdeletion,…
EudraCT-Nummer: 2020-004360-26
Zurück
CLL16
Studieninformationen
Studien-Code
UME-ID-10164
Studien-Akronym
CLL16
Studientitel
A PROSPECTIVE, OPEN-LABEL, MULTICENTER, RANDOMIZED, PHASE 3 TRIAL OF ACALABRUTINIB, OBINUTUZUMAB AND VENETOCLAX (GAVE) COMPARED TO OBINUTUZUMAB AND VENETOCLAX (GVE) IN PREVIOUSLY UNTREATED PATIENTS WITH HIGH RISK (17P-DELETION, TP53- MUTATION OR COMPLEX KARYOTYPE) CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
Kurzbeschreibung
This multicenter, prospective, open-label, randomized, superiority phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the progression-free survival (PFS) as compared to treatment with the combination of obinutuzumab and venetoclax (GVe) in patients with high risk CLL (defined as having at least one of the following risk factors: 17pdeletion, TP53-mutation or complex karyotype).
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2023
EudraCT-Nummer: 2020-004360-26
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Dr. med. Julia von Tresckow

+49 (0)201 723-82530
julia.vontresckow@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Deutsche CLL Studiengruppe (DCLLSG), Universitätsklinik Köln

Studiendesign
randomisiert, offen, Multizentrisch
Einschlusskriterien
01. Documented CLL/SLL³ requiring treatment according to iwCLL criteria1.
02. Age at least 18 years.
03. At least one of the following risk factors: 17p- deletion, TP53 mutation, complex karyotype (defined as defined as the presence of 3 or more chromosomal aberrations in 2 or more metaphases.
04. Life expectancy ≥ 6 months.
05. Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2.
06. Ability and willingness to provide written informed consent and to adhere to the study visitschedule and other protocol requirements.
07. Adequate bone marrow function indicated by a platelet count >30 x10^9/l (unless directlyattributable to CLL infiltration of the bone marrow, proven by bone marrow biopsy).
08. GFR >30 ml/min directly measured with 24hr urine collection, calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x bodyweight) / (72 x creatinine), for women x 0, 85) or an equally accurate method. For patients with creatinine values within the normal range the calculation of the clearance is not necessary. Dehydrated patients with an estimated creatinine clearance less than 30 ml/min may be eligible if a repeat estimate after adequate hydration is > 30 ml/min.
9. Adequate liver function as indicated by a total bilirubin ≤ 2 x, AST/ALT ≤ 2.5 x the institutional ULN value, unless directly attributable to the patient’s CLL or to Gilbert’s Syndrome.
10. Negative serological testing for hepatitis B (HBsAg negative and anti-HBc negative; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBVDNA PCR is performed every month until 12 months after last treatment cycle), negative testing for hepatitis C RNA within 6 weeks prior to registration.

³ Patients with SLL are eligible with confirmation of clonal b-cells in the peripheral blood by immunophenotyping. Patients with
SLL without any leukemic manifestation are not eligible.
Ausschlusskriterien
01. Any prior CLL-specific therapies (except corticosteroid treatment administered due to necessary immediate intervention; within the last 10 days before start of study treatment, only dose equivalents up to 20 mg prednisolone are permitted).
02. Transformation of CLL (Richter‘s transformation).
03. Known central nervous system involvement.
04. An individual organ/system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system (note that symptoms related to CLL should not be included in the patient’s screening CIRS score). Investigators should consult the General Rules for Severity Rating as well as the Organ-Specific Categories when assigning scores for certain conditions (i.e., pulmonary embolism) and consider the level of morbidity associated with a patient’s condition. Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator’s opinion, could compromise the subject’s safety or put the study at risk.
05. Decompensated hemolysis, defined as ongoing hemoglobin drop in spite of prednisolone or intravenous immunoglobulins (IVIG) being administered for hemolysis. Prior treatment with rituximab also for other indications than CLL is not permitted.
06. Patients with a history of confirmed progressive multifocal leukoencephalopathy.
07. Malignancies other than CLL currently requiring systemic therapies, not being treated with curative intent before (unless the malignant disease is in a stable remission due to the discretion of the treating physician) or showing signs of progression after curative treatment.
08. Patients with active infections requiring IV treatment (Grade 3 or 4) within the last 2 months prior to enrollment.
09. Patients with known infection with human immunodeficiency virus (HIV).
10. Requirement of therapy with strong CYP3A4 and CYP3A5 inhibitors/inducers.
11. Anticoagulant therapy with warfarin or phenoprocoumon, (alternative anticoagulation is allowed (e.g. DOACs), but patients must be properly informed
about the potential risk of bleeding under treatment with acalabrutinib).
12. Requirement of treatment with a PPI (proton pump inhibitor). If treatment with an acid reducing agent is required, consider using an antacid (e.g., calcium carbonate) or an H2- receptor antagonist (e.g. ranitidine or famotidine) instead.
13. History of stroke or intracranial hemorrhage within 6 months prior to registration.
14. Use of investigational agents which might interfere with the study drug within 28 days prior to registration.
15. Vaccination with live vaccines 28 days prior to registration.
16. Major surgery less than 30 days before start of treatment.
17. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, known sensitivity or allergy to murine products.
18. Known hypersensitivity to any active substance or to any of the excipients of one of the
drugs used in the trial.
19. Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment; further pregnancy testing will be performed regularly see chapter 2.3.1.5).
20. Fertile men or women of childbearing potential unless:
a. surgically sterile or = 2 years after the onset of menopause.
b. willing to use two methods of reliable contraception including one highly effective contraceptive method (Pearl Index <1) and one additional effective (barrier) method during study treatment and for 18 months after the end of study treatment.
21. Inability to swallow a large number of tablets.
22. Legal incapacity.
23. Prisoners or subjects who are institutionalized by regulatory or court order or persons who are in dependence to the sponsor or an investigator.
Studienteilnehmende Mindestalter
18 Jahr(e)
Indikation
CLL - Chronische lymphatische Leukämie
Medizinischer Befund
Chronic lymphocytic leukemia (CLL): High risk patients defined as having at least one of the following risk factors: 17p-deletion, TP53-mutation or complex karyotype
MK-3475-365
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
EudraCT-Nummer: 2016-002312-41
Zurück
MK-3475-365
Studieninformationen
Studien-Code
UME-ID-10091
Studien-Akronym
MK-3475-365
Studientitel
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022
EudraCT-Nummer: 2016-002312-41
Beteiligte
Institute
Klinik für Urologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Viktor Grünwald

+49 (0)201 723-3213
urologie.studien@uk-essen.de

Hufelandstr. 55
45147 Essen

Sponsor

MSD Merck Sharp & Dohme LLC

Studiendesign
nicht-randomisiert, offen, Multizentrisch, International
Einschlusskriterien
- For Cohorts A, B, C, D, E, G: Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
-- For Cohorts F, H, I: Has t-NE or de novo metastatic prostate cancer defined by ≥1% neuroendocrine cells that are located in discrete regions of a recent biopsy specimen from a metastasis as determined by the investigational site and confirmed by central histology review prior to enrollment
- Is able to provide tumor tissue from a site not previously irradiated as follows: Cohorts A, E, and G: must provide a core or excisional biopsy from soft tissue or bone biopsy within 1 year of screening and after developing mCRPC; Cohort B: must provide an archival tumor tissue sample or tumor tissue from a newly obtained core or excisional biopsy from soft tissue if the lesion is clinically accessible; Cohorts C and D with soft tissue disease: must provide a core or excisional biopsy from a soft tissue lesion if clinically accessible within 1 year of screening and after developing mCRPC and an archival specimen if available; and Cohorts F, H, and I must provide a core or excisional biopsy from soft tissue or a bone biopsy. For de novo metastatic neuroendocrine prostate participants, biopsies must be performed within 1 year of screening. Participants with bone metastasis only must provide an archival tumor tissue specimen.
- Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on Response Evaluation Criteria In Solid Tumors Version 1.1 criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression. Participants with de novo neuroendocrine prostate cancer will not need to provide evidence of progression within 6 months
- Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM). Treatment with luteinizing hormone-releasing hormone agonists or antagonists for all cohorts must have been initiated ≥4 weeks prior to first dose of study therapy and must be continued throughout the study. Participants with de novo metastatic NE prostate cancer will not be required to have been previously treated with androgen deprivation therapy (ADT). ADT must be started in these participants by the time of treatment allocation/randomization
- Participants receiving bone resorptive therapy (including, but not limited to bisphosphonate or receptor activator of nuclear factor kappa-β ligand inhibitor) must be on stable doses for ≥4 weeks prior to first dose of study therapy
- Must be abstinent from heterosexual intercourse, refrain from donating sperm, or agree to use contraception (unless confirmed to be azoospermic) during the intervention period starting with the first dose of study therapy. The length of time required to continue contraception after the last dose of study intervention for each study intervention is as follows: 7 days for abiraterone acetate and lenvatinib; 30 days for enzalutamide; and 95 days for olaparib, docetaxel, and carboplatin/etoposide. No contraception measures are required during and after the intervention period for pembrolizumab/vibostolimab coformulation.
- Has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale for Cohorts A and C and a performance status of 0 or 1 for Cohorts B, D, E, F, G, H, and I within 10 days of study start
- For Cohort A: Has received docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC is allowed. Up to 2 second-generation hormonal manipulations (e.g., abiraterone acetate and/or enzalutamide) are allowed. Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to day 1 of Cycle 1
- For Cohort B: Has received prior treatment with either abiraterone acetate or enzalutamide (but not both) in the prechemotherapy mCRPC state. Participants in Cohort B must have received at least 4 weeks of either abiraterone or enzalutamide treatment (but not both) who failed treatment or became intolerant of the drug
- For Cohort C: Has received prior treatment with abiraterone acetate in the pre-chemotherapy mCRPC state without prior enzalutamide. Participants in Cohort C must have received at least 4 weeks of abiraterone treatment who failed treatment or become intolerant of the drug. Participants who received abiraterone acetate in the hormone-sensitive state will not be eligible
- For Cohort D: Has not received chemotherapy for mCRPC and has either not had prior second generation hormonal manipulation for mCRPC OR has previously been treated with enzalutamide for mCRPC and failed treatment or has become intolerant of the drug. Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel. Prior treatment with abiraterone acetate in the hormone-sensitive metastatic setting is allowed as long as there was no progression on this agent and abiraterone acetate was not discontinued due to adverse events (AEs)
- For Cohorts E and G: Has received docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC is allowed. Up to 2 second-generation hormonal manipulations (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide or other next-generation hormonal agents [NHA]) are allowed. Participants who received prior ketoconazole for metastatic disease may be enrolled. If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy. Prior docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC) is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to Day 1 of Cycle 1
- For Cohort F, H, and I: Participants must have received prior treatment with androgen deprivation therapy (ADT) for metastatic disease. Participants must also have received prior treatment with an NHA (eg, abiraterone acetate, apalutamide, darolutamide, enzalutamide, or other NHA) or docetaxel for mHSPC or mCRPC. Prior treatment with up to a total of 2 chemotherapies for mCRPC is allowed, as well as up to 2 second-generation hormonal manipulations for mCRPC. Participants who received prior ketoconazole for metastatic disease may be enrolled. Docetaxel for mHSPC is allowed in addition to docetaxel for mCRPC. If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy.
Ausschlusskriterien
- Has had a prior anticancer monoclonal antibody (mAb) within 4 weeks prior to first dose study therapy or who has not recovered (i.e., Grade =1 or at baseline) from AEs due to mAbs administered >4 weeks earlier
- Has had prior chemotherapy, targeted small molecule therapy abiraterone treatment, enzalutamide treatment, or radiation therapy within 2 weeks prior to first dose of study therapy or who has not recovered (ie, Grade =1 or at baseline) from AEs due to a previously administered agent
- Is currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study drug or used an investigational device within 4 weeks of treatment allocation/randomization
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to treatment allocation/randomization
- Has had prior treatment with therapeutic radiopharmaceuticals for prostate cancer, such as Radium-223 or Leutitium-177, within 4 weeks prior to the first dose of trial treatment
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
- Has previously participated in any other pembrolizumab trial, or received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), and anti-programmed cell death ligand 1 (anti-PD-L2)
- Has a known history of Human Immunodeficiency Virus (HIV)
- Has known active Hepatitis B or Hepatitis C
- Has received a live vaccine or live-attenuated vaccine within 30 days of the first dose of study therapy. Any licensed COVID-19 vaccine (including for emergency use) in a particular country is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy. Investigational vaccines (ie, those not licensed or approved for emergency use) are not allowed
- Has known active central nervous system metastases and/or carcinomatous meningitis
- Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated
- Has had prior solid, organ or bone marrow transplant
- For Cohort A: Has experienced a seizure or seizures within 6 months of study start or is currently being treated with cytochrome P450 enzyme (CYP) inducing anti-epileptic drugs for seizures
- For Cohort A: Is currently receiving strong or moderate inhibitors of CYP3A4 including azole antifungals; macrolide antibiotics; or protease inhibitors
- For Cohort A: Is currently receiving strong or moderate inducers of CYP3A4
- For Cohort A: Has myelodysplastic syndrome
- For Cohort A: Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease), unstable angina pectoris, cardiac arrhythmia, or uncontrolled hypertension
- For Cohort B: Has received prior treatment with docetaxel or another chemotherapy agent for metastatic prostate cancer
- For Cohort B: Has peripheral neuropathy Common Terminology Criteria for Adverse Events =2 except due to trauma
- For Cohort B: Has ascites and/or clinically significant pleural effusion
- For Cohort B: Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
- For Cohort B: Is currently receiving any of the following classes of inhibitors of CYP3A4: azole antifungals; macrolide antibiotics; or protease inhibitors
- For Cohort C: Has received prior chemotherapy for mCRPC. Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if =4 weeks elapsed from last dose of docetaxel. Participants who received abiraterone acetate in the hormone-sensitive state will not be eligible
- For Cohort C: Has a history of seizure or any condition that may predispose to seizure (including, but not limited to prior cerebrovascular accident, transient ischemic attack, or brain arteriovenous malformation; or intracranial masses such as a schwannoma or meningioma that is causing edema or mass effect)
- For Cohort C: Has known or suspected brain metastasis or leptomeningeal carcinomatosis
- For Cohort C: Has a history of loss of consciousness within 12 months of the screening visit
- For Cohort C: Has hypotension (systolic blood pressure 170 mmHg or diastolic blood pressure >105 mmHg) at the screening visit
- For Cohort C: Has received treatment with 5-a reductase inhibitors (e.g., finasteride, dutasteride), estrogens, and/or cyproterone within 4 weeks prior to Cycle 1
- For Cohort C: Has a history of prostate cancer progression on ketoconazole
- For Cohort D: Has received prior treatment with docetaxel or another chemotherapy agent for metastatic prostate cancer
- For Cohort D: Has progressed on prior abiraterone acetate for treatment of castration sensitive or resistant metastatic prostate cancer
- For Cohort D: Has discontinued prior treatment with abiraterone acetate due to AEs
- For Cohort D: Has previously been treated with ketoconazole for prostate cancer for >7 days
- For Cohort D: Has received prior systemic treatment with an azole drug (eg, fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
- For Cohort D: Has uncontrolled hypertension (systolic BP = 160 mm Hg or diastolic BP = 95 mm Hg)
- For Cohort D: Has a history of pituitary or adrenal dysfunction
- For Cohort D: Has clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class II-IV heart disease or cardiac ejection fraction measurement of <50% at baseline
- For Cohort D: Has atrial fibrillation, or other cardiac arrhythmia requiring therapy
- For Cohort D: Has a history of chronic liver disease
- For Cohort D: Is currently receiving strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) during abiraterone acetate treatment, CYP2D6 substrates with a narrow therapeutic index (for example thioridazine), or CYP2C8 substrates with a narrow therapeutic index (for example pioglitazone)
- For Cohorts E and F: Has a left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO)
- For Cohorts E and F: Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
- For Cohorts E and F: Has prolongation of QT interval by Fredericia (QTcF) interval to >480 milliseconds
- For Cohorts E and F: Has had major surgery within 3 weeks prior to first dose of study interventions
- For Cohorts E and F: Has pre-existing =Grade 3 gastrointestinal or non-gastrointestinal fistula
- For Cohorts E and F: Has had significant cardiovascular impairment within 12 months of the first dose of study intervention, such as history of New York Heart Association >Class II congestive heart failure, unstable angina, myocardial infarction, or cerebrovascular accident (CVA)/stroke, cardiac revascularization procedure, or cardiac arrhythmia associated with hemodynamic instability
- For Cohorts E and F: Has active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of lenvatinib
- For Cohorts E and F: Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
- For Cohorts G, H, and I: Has had a severe hypersensitivity reaction to treatment with another monoclonal antibody
- For Cohorts G, H, and I: Has symptomatic ascites or pleural effusion
- For Cohort I: Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, and/or abdominal carcinomatosis
- For Cohort I: Has received previous treatment for prostate cancer with platinum-containing compoundsHas had a prior anticancer monoclonal antibody (mAb) within 4 weeks prior to first dose study therapy or who has not recovered (i.e., Grade =1 or at baseline) from AEs due to mAbs administered >4 weeks earlier
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich
Indikation
Urogenitale Tumore
Medizinischer Befund
Metastatic Castration-Resistant Prostate Cancer
MedDRA Term
Castration-resistant prostate cancer
ATX-NS-001
An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T cells in Patients with Advanced Non-Small Cell Lung Cancer (CHIRON)
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
EudraCT-Nummer: 2018-001005-85
Zurück
ATX-NS-001
Studieninformationen
Studien-Code
UME-ID-9658
Studien-Akronym
ATX-NS-001
Studientitel
An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T cells in Patients with Advanced Non-Small Cell Lung Cancer (CHIRON)
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2022,2023
EudraCT-Nummer: 2018-001005-85
Beteiligte
Institute
Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Schuler

martin.schuler@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Achilles Therapeutics Limited, Großbritannien

Studiendesign
nicht-randomisiert, offen, nicht-kontrolliert, Multizentrisch
Einschlusskriterien
Inclusion criteria will apply at multiple timepoints.

Inclusion Criteria:
1. Patient must be at least 18 years old at the screening visit.
2. Patient must have given written informed consent to participate in the study.
3. Patient must have histologically confirmed diagnosis of non-small cell lung cancer, which is considered to be smoking-related.
4. Patient is considered medically fit enough to undergo all study procedures and interventions: procedures to procure blood and tumour tissue, including a general anaesthetic if required, and to receive fludarabine, cyclophosphamide and IL-2 at protocol doses and schedules.
5. Patient is considered, in the opinion of the Investigator, capable of adhering to the protocol.
6. ECOG Performance Status 0-1.
7. Adequate organ function, indicated by the following laboratory parameters:
a. Haemoglobin ≥ 10.0 g/dL.
b. White Blood Cell Count (WBC) ≥ 3.0 x10⁹/L.
c. Absolute Neutrophil Count (ANC) ≥ 1.5 x10⁹/L.
d. Platelets ≥ 100 x10⁹/L.
e. PT and APTT < 1.5x ULN (unless receiving therapeutic anticoagulation).
f. AST or ALT ≤ 2.5x ULN.
g. Bilirubin < 1.5x ULN (or < 3 x ULN in Gilbert’s Syndrome).
h. Creatinine clearance/estimated GFR ≥ 50 mL/min.
8. Female patients who are of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 12 months after the ATL001 infusion. Nonsterilised male participants who intend to be sexually active with a female partner of childbearing potential must use an acceptable method of contraception from the time of screening, throughout the duration of the study and for at least 6 months after the ATL001 infusion. Refer to Appendix F for pregnancy testing requirements in Germany. See Section 4.3 for details of acceptable methods of contraception.
In addition to 1-8, the following inclusion criteria must be met prior to tissue procurement:
9. To be eligible to enter this study for procurement, a patient must fall into one of the following
groups:
a. Patients with advanced stage (III-IV) NSCLC who have accessible sites of disease suitable for collection of adequate tissue for ATL001 manufacture prior to starting standard treatment (these patients will not receive ATL001 until their disease has progressed following standard of care therapies, or if they cannot tolerate standard of care therapies – see inclusion number 11).
b. Patients with advanced stage (III-IV) NSCLC who have received or are receiving standard treatments and have accessible sites of disease suitable for collection of adequate tissue for ATL001 manufacture.
c. Other patients with advanced stage disease for whom no other alternative approved treatments are available, may be considered on a case-by-case basis and should be discussed with the Sponsor prior to enrolment.
10. Anticipated life expectancy ≥ 6 months at the time of tissue procurement.
In addition to 1-8, the following inclusion criteria must be met prior to lymphodepletion for treatment with ATL001:
11. Patients must have locally advanced unresectable or metastatic NSCLC whose disease has progressed or recurred following standard of care or who are ineligible for, or who cannot tolerate, standard of care therapies, e.g. platinum-based chemotherapy and an immune checkpoint inhibitor.
12. Patients must have measurable disease according to RECIST v1.1 criteria prior to lymphodepletion. (If patients have no measurable disease following standard therapy, lymphodepletion and ATL001 treatment may be delayed until there is evidence of measurable disease).
13. Patient is considered, in the opinion of the Investigator, well enough (i.e. ECOG Performance Status 0-1) to receive ATL001 treatment (This will be checked prior to lymphodepletion and again prior to receiving ATL001).
In addition to 1-13, the following inclusion criteria must be met for patients to be eligible for treatment in Cohort B:
14. Prior to treatment with ATL001, the most recent treatment regimen must have included a PD- 1/PD-L1 inhibitor and patients should have experienced radiological disease progression on this treatment regimen.
15. In addition to the need for highly effective contraception as outlined in Inclusion Criterion 8 above, female patients in Cohort B of childbearing potential must agree to use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab. Patients must also agree to provide a urine pregnancy test before each pembrolizumab administration during the treatment period in Cohort B.
Ausschlusskriterien
Exclusion criteria will apply at multiple timepoints.

Exclusion Criteria:
1. Patients with known CNS metastases at the time of screening.
2. Patients with hepatitis B or C, human immunodeficiency virus infection (HIV1/2), syphilis or HTLVI/II infection (see Section 6.1.1).
3. Patients who have never smoked (defined as having smoked < 100 cigarettes in their lifetime, per WHO criteria).
4. Patients for whom there is documented evidence of an actionable tumour driver oncogene mutation (e.g. EGFR, ALK or ROS-1) at the time of initial screening.
5. Patients with active, known, or suspected autoimmune disease requiring immunosuppressive treatments.
6. Patients requiring regular treatment with steroids at a dose higher than prednisolone 10 mg/day (or equivalent).
7. Patients with superior vena cava syndrome.
8. Patients with a current or recent history, as determined by the Investigator, of clinically significant, progressive, and/or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, gastroenterological or neurological disease.
9. Patients with a history of immune mediated central nervous system toxicity that was caused by, or suspected to be caused by, immunotherapy.
10. Patients with a history of = Grade 2 diarrhoea/colitis caused by previous immunotherapy within 6 months of screening. Patients that have been asymptomatic for at least 6 months or have had a normal colonoscopy post-immunotherapy (with uninflamed mucosa by visual assessment) are
not excluded.
11. Patients who are pregnant or breastfeeding.
12. Patients who have undergone major surgery in the previous 3 weeks.
13. Patients with an active concurrent cancer or a history of cancer within the past 3 years (except for in situ carcinomas, early prostate cancer with normal PSA or non-melanomatous skin cancers).
14. Patients with a history of organ transplantation.
15. Patients who have previously received any investigational cell or gene therapies.
16. Patients with contraindications for cyclophosphamide, fludarabine and IL-2 at per protocol doses (see Investigator’s Brochure for details).
17. Patients who have received any cytotoxic chemotherapy or anti-angiogenesis agent within the 3 weeks prior to tissue and blood procurement.
18. Patients with evidence of disease progression at the first scan after commencing standard first line therapy (i.e. refractory disease).
19. Patients with a known history of allergic reactions to amphotericin b, penicillin and/or streptomycin.
In addition, the following exclusion criteria will apply for eligibility for Cohort B:
20. Patients with any contraindications for pembrolizumab (Refer to the latest available prescribing information (e.g. SmPC) for reference safety information for pembrolizumab).
All exclusion criteria, except 2, 3, 4, 17 and 18, will apply again prior to lymphodepletion for treatment with ATL001.
In addition, the following criteria will apply:
21. Patients who have received a live vaccination within the 28 days prior to lymphodepletion.
22. Patients with an active infection requiring antibiotics.
23. Patients who have received any cytotoxic chemotherapy within the 3 weeks prior to lymphodepletion.
Studienteilnehmende Mindestalter
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Indikation
Lungenkrebs
Medizinischer Befund
Non-small cell lung cancer
IntReALL-HR-2010
IntReALL HR 2010 - International Study for Treatment of High Risk Childhood Relapsed ALL 2010
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
EudraCT-Nummer: 2012-000810-12
Zurück
IntReALL-HR-2010
Studieninformationen
Studien-Code
UME-ID-9928
Studien-Akronym
IntReALL-HR-2010
Studientitel
IntReALL HR 2010 - International Study for Treatment of High Risk Childhood Relapsed ALL 2010
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021
EudraCT-Nummer: 2012-000810-12
Beteiligte
Institute
Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum, WTZMS - Westdeutsches Tumorzentrum Münster
Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Dirk Reinhardt

+49 (0)201 723-3784
dirk.reinhardt@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

Charité - Universitätsmedizin Berlin

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
• Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
• Children less than 18 years of age at date of inclusion into the study
• Meeting HR criteria (any T BM relapse, early/very early isolated BM relapse, very early isolated/combined extramedullary relapse)
• Patient enrolled in a participating centre
• Written informed consent
• Start of treatment falling into the study period
• No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL
Ausschlusskriterien
• BCR-ABL/ t(9;22) positive ALL
• Pregnancy or positive pregnancy test (urine sample positive for ß-HCG > 10 U/l)
• Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
• Breast feeding
• Relapse post allogeneic stem-cell transplantation
• Neuropathy > II°
• The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
• Objection to the study participation by a minor patient, able to object
• Any patient being dependent on the investigator
• No consent is given for saving and propagation of pseudonymized medical data for study reasons
• Severe concomitant disease that does not allow treatment according to the protocol at the investigator’s discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
• Subjects unwilling or unable to comply with the study procedures
• Subjects who are legally detained in an official institute

- No consent is given for saving and propagation of pseudonymized medical data for study reasons
- Severe concomitant disease that does not allow treatment according to the protocol at the investigator’s discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
- Subjects unwilling or unable to comply with the study procedures
- Subjects who are legally detained in an official institute
Studienteilnehmende Mindestalter
0 Tag(e)
Studienteilnehmende Höchstalter
17 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Indikation
KIK-Onko
Medizinischer Befund
Acute lymphoblastic leukemia (ALL)
MC-MSC.1/aGvHD / IDUNN
A Randomised, Open label, Multicentre, Phase 3 Trial of First line Treatment with Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects with Steroid refractory Acute Graft versus host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
An experimental study in adults and adolescents who underwent stem cell transplantation and developed a sustained acute graft rejection after steroid treatment; to test the safety, tolerability and the effects of treatment with mesenchymal stromal cells MC0518
EudraCT-Nummer: 2019-001462-15
Zurück
MC-MSC.1/aGvHD / IDUNN
Studieninformationen
Studien-Code
UME-ID-10096
Studien-Akronym
MC-MSC.1/aGvHD / IDUNN
Studientitel
A Randomised, Open label, Multicentre, Phase 3 Trial of First line Treatment with Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects with Steroid refractory Acute Graft versus host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)
Kurzbeschreibung
An experimental study in adults and adolescents who underwent stem cell transplantation and developed a sustained acute graft rejection after steroid treatment; to test the safety, tolerability and the effects of treatment with mesenchymal stromal cells MC0518
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021
EudraCT-Nummer: 2019-001462-15
Beteiligte
Institute
Klinik für Hämatologie und Stammzelltransplantation, Klinik für Kinderheilkunde III, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Thomas Schroeder

+49 (0)201 723-82530
thomas.schroeder@uk-essen.de

Hufelandstr. 55
45147 Essen

Sponsor

MEDAC, medac Gesellschaft für klinische Spezialpräparate mbH, Hamburg

Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
- Subject had a previous allogeneic HSCT as indicated for malignant or non-malignant haematological disease, irrespective of human leukocyte antigen match.
- Subject has been clinically diagnosed with Grade II to IV aGvHD at the Screening Visit.
- Subject has experienced failure of previous first line aGvHD treatment (ie, SR aGvHD), defined as:
a. aGvHD progression within 3 to 5 days of therapy onset with ? 2 mg/kg/day of prednisone equivalent or
b. failure to improve within 5 to 7 days of treatment initiation with ? 2 mg/kg/day of prednisone equivalent or
c. incomplete response after > 28 days of immunosuppressive treatment including at least 5 days with ? 2 mg/kg/day of prednisone equivalent.
- Male or female subject who is ? 12 years of age and ? 15 kg at the Screening Visit.
- Subject has an estimated life expectancy > 28 days at the Screening Visit (compliance to be re-confirmed at the Baseline Visit).
- Subject, if female and of childbearing potential, agrees to use a highly effective contraceptive measure starting at the Screening Visit and continuing throughout the entire trial period. The definition of women of childbearing potential (WOCBP) and a complete list of highly effective contraceptive measures are included in an appendix to the protocol.
- Subject, if a fertile male, agrees to sexual abstinence or to use a condom during sexual activity with their female partner of childbearing potential or pregnant partner. Additionally, if their partner is a WOCBP, then their partner has to use an additional highly effective contraceptive method during sexual activity starting at the Screening Visit and continuing throughout the entire trial period. The definition of fertile men and a complete list of highly effective contraceptive measures are included in an appendix to the protocol.
- Subject or parent(s) / legal guardian(s) have read, understood, and signed the informed consent form (and informed assent form, if applicable) according to national regulations.
Ausschlusskriterien
- Subject has overt relapse or progression or persistence of the underlying disease at the Screening Visit.
- Subject has received the last HSCT for a solid tumour disease.
- Subject has GvHD overlap syndrome at the Screening Visit.
- Subject has received systemic first line treatment for aGvHD other than steroids and a prophylaxis with other than calcineurin inhibitors, anti thymocyte globulin (ATG), mycophenolate mofetil (MMF), methotrexate (MTX), and or cyclophosphamide before the Screening Visit (compliance
to be re-confirmed at the Baseline Visit).
- Subject has a known pregnancy (as confirmed by a positive pregnancy test at the Screening Visit) and or is breastfeeding at the Screening Visit.
- Subject has received treatment with any other investigational agent within 30 days or 5 half-lives (whichever is longer) before the Screening
Visit (compliance to be confirmed for the period between the Screening Visit and the Baseline Visit at the Baseline Visit).
Studienteilnehmende Mindestalter
12 Jahr(e)
Geschlecht
Männlich
Indikation
KIK-Onko
Medizinischer Befund
Steroid refractory Acute Graft versus host Disease
MedDRA Term
Acute graft versus host disease
CRISP
Clinical Research Platform Into Molecular Testing, Treatment and Outcome of Non-Small Cell Lung Carcinoma Patients (CRISP))
Berufsordnung (BO) / Nicht-interventionell, Multizentrisch
Zurück
CRISP
Studieninformationen
Studien-Code
UME-ID-10235
Studien-Akronym
CRISP
Studientitel
Clinical Research Platform Into Molecular Testing, Treatment and Outcome of Non-Small Cell Lung Carcinoma Patients (CRISP))
Aktueller Studienstatus
Aktiv, rekrutierend
Studie aktiv in den Jahren
2016,2017,2018,2019,2020,2021
Beteiligte
Institute
Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Martin Metzenmacher

martin.metzenmacher@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

AIO-Studien-gGmbH, Berlin

Studiendesign
Kohorten-Studie, Multizentrisch
Einschlusskriterien
Patients who meet all of the following criteria are eligible