EPCORE FL-1
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
Rekrutierend
NCT-Nummer:
NCT05409066
Studienbeginn:
September 2022
Letztes Update:
09.04.2024
Wirkstoff:
Epcoritamab, Rituximab, Lenalidomide
Indikation (Clinical Trials):
Lymphoma, Lymphoma, Follicular
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 3
Sponsor:
AbbVie
Collaborator:
Genmab
Studienleiter
ABBVIE INC. Study DirectorAbbVie
Kontakt
ABBVIE CALL CENTER Kontakt: Phone: 844-663-3742 E-Mail: abbvieclinicaltrials@abbvie.com» Kontaktdaten anzeigen
Studienlocations (3 von 234)
Tucson United States Long Beach Los Angeles Chicago Goshen Worcester Chesterfield Billings Morristown Mineola New York Ciudad Autonoma de Buenos Aire Argentina Cordoba Santa Fe Camperdown Australia Kingswood Douglas Frankston Murdoch Nedlands Perth Sankt Poelten Austria Linz Salzburg Edegem Belgium La Louvière Sint-Niklaas Leuven Liege Turnhout Curitiba Brazil Botucatu Jaú São Paulo Rio de Janeiro Sao Paulo Edmonton Canada Victoria Levis Quebec City Rimouski Beijing China Fuzhou Guangzhou Wuhan Suzhou Xuzhou Nanchang Shenyang Shanghai Tianjin Hangzhou Hradec Kralove Czechia Prague Praha Herning Denmark Vejle Clermont France Rennes Dijon Limoges CEDEX 1 Nimes CEDEX 9 Pessac Reims CEDEX Vandoeuvre-les-Nancy Lille Nantes Lyon CEDEX 08 Pierre Benite CEDEX Poitiers Caen Créteil La Roche Sur Yon Paris Toulouse Cedex 9 Tubingen Baden-Württemberg Germany Gießen Hessen Leipzig Sachsen Jena Thüringen Bamberg Bayern Berlin Bonn Nordrhein-Westfalen Dresden Essen Kassel Magdeburg Sachsen-Anhalt Trier Rheinland-Pfalz Wuerzburg Athens Greece Ioannina Thessaloniki Debrecen Hungary Kaposvár Nyiregyhaza Szombathely Budapest Szeged Haifa Israel Zerifin Safed Ramat Gan Tel Aviv Jerusalem San Giovanni Rotondo Italy Rome Milan Torino Candiolo Alessandria Aviano Brescia Napoli Novara Palermo Ravenna Nagoya-shi Japan Kashiwa-shi Matsuyama-shi Fukuoka-shi Fukushima-shi Sapporo-shi Kobe-shi Kagoshima-shi Isehara-shi Kyoto-shi Tsu-shi Sendai-shi Matsumoto-shi Okayama-shi Osakasayama-shi Chuo-ku Koto-ku Yamagata-shi Seongnam-si Korea, Republic of Seoul Busan Daegu Jeonju Hoorn Nh Netherlands Dordrecht Rotterdam Amsterdam Breda Deventer Enschede Goes Groningen Leiden Nieuwegein Nijmegen Papatoetoe New Zealand Takapuna Palmerston North Krakow Poland Gdynia Kielce Pila Skorzewo Rio Piedras Puerto Rico Johannesburg South Africa Pretoria Cape Town Kuilsrivier Badalona Spain Hospitalet de Llobregat Santander Pamplona Barcelona Caceres Madrid Salamanca Sevilla Lulea Sweden Boras Linkoping Aarau Switzerland Chur St. Gallen Bellinzona Kaohsiung City Taiwan Taichung Tainan Ankara Turkey Antalya Diyarbakir Istanbul Izmir Kocaeli Samsun London United Kingdom Oxford Colchester Leeds Liverpool Manchester Newcastle upon Tyne Plymouth
Universitaetsklinikum Tuebingen /ID# 229663 72076 Tubingen (Baden-Württemberg) GermanyRekrutierend » Google-Maps Universitaetsklinikum Giessen /ID# 234245 35392 Gießen (Hessen) GermanyRekrutierend » Google-Maps Universitaetsklinikum Leipzig /ID# 242907 04103 Leipzig (Sachsen) GermanyRekrutierend » Google-Maps Universitaetsklinikum Jena /ID# 232064 07747 Jena (Thüringen) GermanyRekrutierend » Google-Maps Sozialstiftung Bamberg /ID# 229184 96049 Bamberg (Bayern) GermanyRekrutierend » Google-Maps Helios Klinikum Berlin-Buch /ID# 229178 13125 Berlin (Berlin) GermanyAbgeschlossen » Google-Maps Universitaetsklinikum Bonn /ID# 249401 53127 Bonn (Nordrhein-Westfalen) GermanyRekrutierend » Google-Maps Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 229754 01307 Dresden (Sachsen) GermanyRekrutierend » Google-Maps Universitaetsklinikum Essen /ID# 229180 45147 Essen (Nordrhein-Westfalen) GermanyRekrutierend » Google-Maps Klinikum Kassel /ID# 229185 34125 Kassel (Hessen) GermanyRekrutierend » Google-Maps Otto-von-Guericke-Universitaet /ID# 230144 39120 Magdeburg (Sachsen-Anhalt) GermanyRekrutierend » Google-Maps Klinikum Mutterhaus der Borromäerinnen /ID# 232354 54290 Trier (Rheinland-Pfalz) GermanyRekrutierend » Google-Maps Universitaetsklinikum Wuerzburg /ID# 229278 97080 Wuerzburg (Bayern) GermanyRekrutierend » Google-Maps University of Arizona Cancer Center - 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PONTCHAILLOU /ID# 230356 35000 Rennes FranceRekrutierend » Google-Maps CHU Dijon /ID# 230354 21000 Dijon FranceRekrutierend » Google-Maps CHU Limoges - Dupuytren 1 /ID# 231450 87042 Limoges CEDEX 1 FranceRekrutierend » Google-Maps CHU NIMES - Hopital Caremeau /ID# 230351 30029 Nimes CEDEX 9 FranceRekrutierend » Google-Maps CHU Bordeaux - Hopital Haut Leveque /ID# 230347 33604 Pessac FranceRekrutierend » Google-Maps CHU Reims - Hôpital Robert Debre /ID# 248710 51092 Reims CEDEX FranceRekrutierend » Google-Maps CHRU Nancy - Hopitaux de Brabois /ID# 241595 54500 Vandoeuvre-les-Nancy FranceRekrutierend » Google-Maps CHRU Lille - Hopital Claude Huriez /ID# 230353 59037 Lille FranceRekrutierend » Google-Maps CHU de Nantes, Hotel Dieu -HME /ID# 245928 44000 Nantes FranceRekrutierend » Google-Maps Centre Leon Berard /ID# 230348 69373 Lyon CEDEX 08 FranceRekrutierend » Google-Maps HCL - Hopital Lyon Sud /ID# 231449 69495 Pierre Benite CEDEX FranceRekrutierend » Google-Maps CHU Poitiers - La miletrie /ID# 230357 86000 Poitiers FranceRekrutierend » Google-Maps CHU de CAEN - Hopital de la Cote de Nacre /ID# 245929 14033 Caen FranceRekrutierend » Google-Maps Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 230358 94010 Créteil FranceRekrutierend » Google-Maps CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 234095 85000 La Roche Sur Yon FranceRekrutierend » Google-Maps AP-HP - Hopital Saint-Louis /ID# 232067 75010 Paris FranceRekrutierend » Google-Maps Hopital Pitie Salpetriere /ID# 230360 75013 Paris FranceRekrutierend » Google-Maps IUCT Oncopole /ID# 233486 31059 Toulouse Cedex 9 FranceRekrutierend » Google-Maps General Hospital of Athens Laiko /ID# 226626 11527 Athens GreeceRekrutierend » Google-Maps Alexandra General Hospital /ID# 226632 11528 Athens GreeceRekrutierend » Google-Maps University General Hospital Attikon /ID# 226629 12462 Athens GreeceRekrutierend » Google-Maps General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 226633 10676 Athens GreeceRekrutierend » Google-Maps University General Hospital of Ioannina /ID# 226628 45500 Ioannina GreeceRekrutierend » Google-Maps General University Hospital of Thessaloniki AXEPA /ID# 226630 54636 Thessaloniki GreeceRekrutierend » Google-Maps Theageneio Anticancer Hospital /ID# 226627 54639 Thessaloniki GreeceRekrutierend » Google-Maps Debreceni Egyetem-Klinikai Kozpont /ID# 229287 4032 Debrecen HungaryRekrutierend » Google-Maps Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246475 7400 Kaposvár HungaryRekrutierend » Google-Maps Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 232203 4400 Nyiregyhaza HungaryRekrutierend » Google-Maps Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 229290 9700 Szombathely HungaryRekrutierend » Google-Maps Semmelweis Egyetem /ID# 229291 1085 Budapest HungaryRekrutierend » Google-Maps Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 229286 1097 Budapest HungaryRekrutierend » Google-Maps Orszagos Onkologiai Intezet /ID# 229292 1122 Budapest HungaryRekrutierend » Google-Maps Szegedi Tudományegyetem /ID# 229289 6720 Szeged HungaryRekrutierend » Google-Maps Rambam Health Care Campus /ID# 227849 3109601 Haifa IsraelRekrutierend » Google-Maps Rabin Medical Center /ID# 228043 4941492 Haifa IsraelRekrutierend » Google-Maps Assaf Harofeh Medical Center /ID# 228037 70300 Zerifin IsraelRekrutierend » Google-Maps ZIV Medical Center /ID# 232257 13100 Safed IsraelRekrutierend » Google-Maps The Chaim Sheba Medical Center /ID# 228322 5265601 Ramat Gan IsraelRekrutierend » Google-Maps Tel Aviv Sourasky Medical Center /ID# 228529 6423906 Tel Aviv IsraelRekrutierend » Google-Maps Hadassah /ID# 227846 91120 Jerusalem IsraelRekrutierend » Google-Maps Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 228458 71013 San Giovanni Rotondo ItalyRekrutierend » Google-Maps Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 230402 00168 Rome ItalyRekrutierend » Google-Maps Ospedale San Raffaele IRCCS /ID# 228669 20132 Milan ItalyRekrutierend » Google-Maps IEO -Istituto Europeo di Oncologia /ID# 227396 20141 Milan ItalyRekrutierend » Google-Maps AOU Citta della Salute e della Scienza di Torino /ID# 229820 10126 Torino ItalyRekrutierend » Google-Maps Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 229602 10060 Candiolo ItalyRekrutierend » Google-Maps Azienda Ospedaliera Nazionale SS. 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Brief Summary: Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2. - Participant has: - Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND - >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI. - Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report. - Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.) - Eligible to receive R2 per investigator determination.Exclusion Criteria: - Documented refractoriness to lenalidomide. - Have lenalidomide exposure within 12 months prior to randomization.
Primary outcome: 1. Progression-Free Survival (PFS) (Time Frame - Up to approximately 5 years):PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by independent review committee (IRC) or death (whichever occurs first). Secondary outcome: 1. Percentage of Participants Achieving Complete Response (CR) (Time Frame - Up to approximately 5 years):Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy. 2. Overall Survival (OS) (Time Frame - Up to approximately 8 years from randomization):Overall survival is defined as the duration from the date of randomization to the date of the participant's death. 3. Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity (Time Frame - Up to approximately 5 years):MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of subsequent anti-lymphoma therapy.
Experimental: Epcoritamab Dose A in Combination With R2Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Experimental: Epcoritamab Dose B in Combination With R2Participants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Enrollment is closed for this arm. Active Comparator: Lenalidomide and Rituximab (R2)Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Epcoritamab (GEN3013):Subcutaneous Injection Rituximab:Intravenous Infusion Lenalidomide:Oral Capsules
Quelle: ClinicalTrials.gov
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"Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma"
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