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 (EPCORE FL-1)
Follicular Lymphoma (FL)
About this trial
This is an interventional treatment trial for Follicular Lymphoma (FL) focused on measuring Follicular Lymphoma (FL), Non-Hodgkin's lymphoma (NHL), Lymphoma, Cancer, Epcoritamab, Rituximab, Lenalidomide, EPCORE FL-1, EPCORE
Eligibility Criteria
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 and short axis > 1.0 cm) or >= 1 measurable extra-nodal lesion (long axis >= 1.0 cm) on CT scan or MRI.
- Histologically confirmed Grade 1 to 3a follicular lymphoma (FL) according to the World Health Organization (WHO) 2016 classification with no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy and CD20+ on a 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 (an)other anti-lymphoma agent(s).
- Eligible to receive R2 per investigator determination.
Exclusion Criteria:
- Documented refractoriness to lenalidomide.
- Have lenalidomide exposure within 12 months prior to randomization.
Sites / Locations
- Fundaleu /Id# 229700Recruiting
- Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 232124Recruiting
- Royal Prince Alfred Hospital /ID# 239272Recruiting
- Nepean Hospital /ID# 239093Recruiting
- Townsville University Hospital /ID# 231124Recruiting
- Fiona Stanley Hospital /ID# 231122Recruiting
- Hollywood Medical Centre /ID# 251789Recruiting
- Royal Perth Hospital /ID# 230456Recruiting
- Peninsula Private Hospital /ID# 238796Recruiting
- Universitaetsklinikum St. Poelten /ID# 234015Recruiting
- Ordensklinikum Linz GmbH Elisabethinen /ID# 247510Recruiting
- Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 228366Recruiting
- Uza /Id# 228521Recruiting
- Universitair Ziekenhuis Leuven /ID# 247780Recruiting
- Pôle Hospitalier Jolimont /ID# 228520Recruiting
- Groupe Sante CHC - Clinique du MontLegia /ID# 230415Recruiting
- Vitaz /Id# 228525Recruiting
- AZ Turnhout - Campus Sint-Elisabeth /ID# 231628Recruiting
- Upeclin Fmb - Unesp /Id# 252912Recruiting
- Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 228129Recruiting
- Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 228130Recruiting
- Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 228706Recruiting
- Real e Benemérita Associação Portuguesa de Beneficência /ID# 228121Recruiting
- Instituto D'or de Ensino e Pesquisa - Regional Sao Paulo /ID# 252918Recruiting
- Instituto de Assistencia Medica ao Servidor Publico Estadual /ID# 230182Recruiting
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 228127Recruiting
- Cross Cancer Institute /ID# 249080Recruiting
- BC Cancer - Victoria /ID# 228850Recruiting
- CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229896Recruiting
- CISSSBSL -Hopital regional de Rimouski /ID# 229894Recruiting
- Fakultni nemocnice Hradec Kralove /ID# 228269Recruiting
- Fakultni Nemocnice v Motole /ID# 228272Recruiting
- Regionshospitalet Godstrup /ID# 227466Recruiting
- Sygehus Lillebalt, Vejle /ID# 227404Recruiting
- CHU Clermont-Ferrand /ID# 238676Recruiting
- HCL - Hopital Lyon Sud /ID# 231449Recruiting
- CHU de Rennes - PONTCHAILLOU /ID# 230356Recruiting
- CHU Dijon /ID# 230354Recruiting
- CHU Limoges - Dupuytren 1 /ID# 231450Recruiting
- CHU NIMES - Hopital Caremeau /ID# 230351Recruiting
- CHU Bordeaux - Hopital Haut Leveque /ID# 230347Recruiting
- CHRU Lille - Hopital Claude Huriez /ID# 230353Recruiting
- CHU Reims - Hôpital Robert Debre /ID# 248710Recruiting
- CHRU Nancy - Hopitaux de Brabois /ID# 241595Recruiting
- CHU de Nantes, Hotel Dieu -HME /ID# 245928Recruiting
- Centre Leon Berard /ID# 230348Recruiting
- CHU Poitiers - La miletrie /ID# 230357Recruiting
- CHU de CAEN - Hopital de la Cote de Nacre /ID# 245929Recruiting
- Hopital Henri Mondor /ID# 230358Recruiting
- CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 234095Recruiting
- AP-HP - Hopital Saint-Louis /ID# 232067Recruiting
- Hopital Pitie Salpetriere /ID# 230360Recruiting
- IUCT Oncopole /ID# 233486Recruiting
- Sozialstiftung Bamberg /ID# 229184Recruiting
- Helios Klinikum Berlin-Buch /ID# 229178Recruiting
- Universitaetsklinikum Essen /ID# 229180Recruiting
- Klinikum Kassel /ID# 229185Recruiting
- Klinikum Mutterhaus der Borromäerinnen /ID# 232354Recruiting
- Universitaetsklinikum Wuerzburg /ID# 229278Recruiting
- General Hospital of Athens Laiko /ID# 226626Recruiting
- Alexandra General Hospital /ID# 226632Recruiting
- University General Hospital Attikon /ID# 226629Recruiting
- General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 226633Recruiting
- University General Hospital of Ioannina /ID# 226628Recruiting
- General University Hospital of Thessaloniki AXEPA /ID# 226630Recruiting
- Theageneio Anticancer Hospital /ID# 226627Recruiting
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 229289Recruiting
- Debreceni Egyetem Klinikai Kozpont /ID# 229287Recruiting
- Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246475Recruiting
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 232203Recruiting
- Markusovszky Egyetemi Oktatokorhaz /ID# 229290Recruiting
- Semmelweis Egyetem /ID# 229291Recruiting
- Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 229286Recruiting
- Orszagos Onkologiai Intezet /ID# 229292Recruiting
- The Chaim Sheba Medical Center /ID# 228322Recruiting
- Tel Aviv Sourasky Medical Center /ID# 228529Recruiting
- Assaf Harofeh Medical Center /ID# 228037Recruiting
- Rambam Health Care Campus /ID# 227849Recruiting
- Hadassah /ID# 227846Recruiting
- Rabin Medical Center /ID# 228043Recruiting
- Ziv Medical Center /ID# 232257Recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 230402Recruiting
- IEO -Istituto Europeo di Oncologia /ID# 227396Recruiting
- Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 229602Recruiting
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 227401Recruiting
- ASST Spedali civili di Brescia /ID# 227397Recruiting
- Azienda Ospedaliera Universitaria Federico II /ID# 230403Recruiting
- Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 227399Recruiting
- A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 227402Recruiting
- Ospedale Santa Maria delle Croci /ID# 227394Recruiting
- Seoul National University Bundang Hospital /ID# 228448Recruiting
- Inje University Busan Paik Hospital /ID# 230293Recruiting
- Dong-A University Hospital /ID# 228638Recruiting
- Pusan National University Hospital /ID# 229798Recruiting
- Keimyung University Dongsan Medical Center /ID# 229800Recruiting
- Jeonbuk National University Hospital /ID# 228908Recruiting
- Seoul National University Hospital /ID# 228446Recruiting
- Asan Medical Center /ID# 228444Recruiting
- Samsung Medical Center /ID# 228445Recruiting
- The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 228447Recruiting
- Dijklander Ziekenhuis /ID# 248993Recruiting
- Albert Schweitzer Ziekenhuis /ID# 247740Recruiting
- Onze Lieve Vrouwe Gasthuis /ID# 247899Recruiting
- Deventer Ziekenhuis /ID# 247853Recruiting
- Medisch Spectrum Twente /ID# 247854Recruiting
- Admiraal de Ruyter Ziekenhuis /ID# 247692Recruiting
- Universitair Medisch Centrum Groningen /ID# 247741Recruiting
- Leids Universitair Medisch Centrum /ID# 247742Recruiting
- St. Antonius Ziekenhuis /ID# 248644Recruiting
- Franciscus Gasthuis & Vlietland /ID# 248139Recruiting
- Aotearoa Clinical Trials /ID# 228509Recruiting
- North Shore Hospital /ID# 228508Recruiting
- Palmerston North Hospital /ID# 232352Recruiting
- Pratia MCM Krakow /ID# 229121Recruiting
- Szpitale Pomorskie Sp. z o.o /ID# 229122Recruiting
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 229362Recruiting
- ARS-MEDICAL Sp. z o.o. /ID# 229601
- Centrum Medyczne Pratia Poznan /ID# 229299Recruiting
- Alberts Cellular Therapy /ID# 228896Recruiting
- Instituto Catalan de Oncologia (ICO) Badalona /ID# 228108Recruiting
- Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 228107Recruiting
- Hospital Unversitario Marques de Valdecilla /ID# 228984Recruiting
- CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 228116Recruiting
- Hospital Parc de Salut del Mar /ID# 228106Recruiting
- Hospital Santa Creu i Sant Pau /ID# 229859Recruiting
- Hospital San Pedro de Alcantara /ID# 248845Recruiting
- Hospital Universitario Reina Sofia /ID# 228122Recruiting
- CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 229157Recruiting
- MD Anderson Madrid /ID# 229860Recruiting
- Hospital Universitario Ramon y Cajal /ID# 228113Recruiting
- Hospital Universitario Fundacion Jimenez Diaz /ID# 228110Recruiting
- Hospital Universitario 12 de Octubre /ID# 228109Recruiting
- Hospital Universitario de Salamanca /ID# 228117Recruiting
- Hospital Universitario Virgen del Rocio /ID# 228118Recruiting
- Sunderby sjukhus /ID# 228165Recruiting
- Sodra Alvsborgs sjukhus /ID# 228886Recruiting
- Linkoping University Hospital /ID# 233520Recruiting
- Kantonsspital Aarau AG /ID# 229113Recruiting
- Kantonsspital St. Gallen /ID# 229117Recruiting
- EOC Ospedale Regionale di Bellinzona e Valli /ID# 228922Recruiting
- Kaohsiung Chang Gung Memorial Hospital /ID# 227384Recruiting
- China Medical University Hospital /ID# 227379Recruiting
- Taichung Veterans General Hospital /ID# 227383Recruiting
- National Cheng Kung University Hospital /ID# 227381Recruiting
- Ankara Universitesi Fakultesi /ID# 227790Recruiting
- Akdeniz Universitesi Tip Fakul /ID# 227791Recruiting
- Dicle Universitesi Tip /ID# 230087Recruiting
- Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 248202Recruiting
- Istanbul Florence Nightingale Hastanesi /ID# 229546Recruiting
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 227855Recruiting
- Ege University Medical Faculty /ID# 227792Recruiting
- Kocaeli University Med Faculty /ID# 227854Recruiting
- Ondokuz mayis University Facul /ID# 227794Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Epcoritamab Dose A in Combination With R2
Epcoritamab Dose B in Combination With R2
Lenalidomide and Rituximab (R2)
Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Participants 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.
Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).