Non Hodgkin Lymphoma Clinical Trial

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

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. Around 642 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.

View Eligibility Criteria

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

642

Study ID:

NCT05409066

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 121 Locations for this study

See Locations Near You

Royal Prince Alfred Hospital /ID# 239272
Camperdown New South Wales, 2050, Australia
Nepean Hospital /ID# 239093
Kingswood New South Wales, 2747, Australia
Townsville University Hospital /ID# 231124
Douglas Queensland, 4814, Australia
Fiona Stanley Hospital /ID# 231122
Murdoch Western Australia, 6150, Australia
Royal Perth Hospital /ID# 230456
Perth Western Australia, 6000, Australia
Peninsula Private Hospital /ID# 238796
Langwarrin , 3910, Australia
Universitaetsklinikum St. Poelten /ID# 234015
Sankt Poelten Niederoesterreich, 3100, Austria
Ordensklinikum Linz GmbH Elisabethinen /ID# 247510
Linz Oberoesterreich, 4010, Austria
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 228366
Salzburg , 5020, Austria
Uza /Id# 228521
Edegem Antwerpen, 2650, Belgium
Universitair Ziekenhuis Leuven /ID# 247780
Leuven Vlaams-Brabant, 3000, Belgium
Pôle Hospitalier Jolimont /ID# 228520
La Louvière , 7100, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 230415
Liege , 4000, Belgium
Vitaz /Id# 228525
Sint-Niklaas , 9100, Belgium
AZ Turnhout - Campus Sint-Elisabeth /ID# 231628
Turnhout , 2300, Belgium
BC Cancer - Victoria /ID# 228850
Victoria British Columbia, V8R 6, Canada
CISSSBSL -Hopital regional de Rimouski /ID# 229894
Rimouski Quebec, G5L 5, Canada
Fakultni nemocnice Hradec Kralove /ID# 228269
Hradec Kralove , 500 0, Czechia
Regionshospitalet Godstrup /ID# 227466
Herning Midtjylland, 7400, Denmark
Sygehus Lillebalt, Vejle /ID# 227404
Vejle Syddanmark, 7100, Denmark
CHU Clermont-Ferrand /ID# 238676
Clermont Auvergne-Rhone-Alpes, 63100, France
HCL - Hopital Lyon Sud /ID# 231449
Pierre Benite CEDEX Auvergne-Rhone-Alpes, 69495, France
CHU de Rennes - PONTCHAILLOU /ID# 230356
Rennes Bretagne, 35000, France
CHU Dijon /ID# 230354
Dijon Cote-d Or, 21000, France
CHU Limoges - Dupuytren 1 /ID# 231450
Limoges CEDEX 1 Franche-Comte, 87042, France
CHU NIMES - Hopital Caremeau /ID# 230351
Nimes CEDEX 9 Gard, 30029, France
CHU Bordeaux - Hopital Haut Leveque /ID# 230347
Pessac Gironde, 33604, France
CHRU Lille - Hopital Claude Huriez /ID# 230353
Lille Hauts-de-France, 59037, France
CHU Reims - Hôpital Robert Debre /ID# 248710
Reims CEDEX Marne, 51092, France
CHRU Nancy - Hopitaux de Brabois /ID# 241595
Vandoeuvre-les-Nancy Meurthe-et-Moselle, 54500, France
CHU de Nantes, Hotel Dieu -HME /ID# 245928
Nantes Pays-de-la-Loire, 44000, France
Centre Leon Berard /ID# 230348
Lyon CEDEX 08 Rhone, 69373, France
CHU Poitiers - La miletrie /ID# 230357
Poitiers Vienne, 86000, France
CHU de CAEN - Hopital de la Cote de Nacre /ID# 245929
Caen , 14033, France
Hopital Henri Mondor /ID# 230358
Creteil , 94000, France
AP-HP - Hopital Saint-Louis /ID# 232067
Paris , 75010, France
Hopital Pitie Salpetriere /ID# 230360
Paris , 75013, France
IUCT Oncopole /ID# 233486
Toulouse Cedex 9 , 31059, France
General Hospital of Athens Laiko /ID# 226626
Athens Attiki, 11527, Greece
Alexandra General Hospital /ID# 226632
Athens Attiki, 11528, Greece
University General Hospital Attikon /ID# 226629
Athens Attiki, 12462, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 226633
Athens , 10676, Greece
University General Hospital of Ioannina /ID# 226628
Ioannina , 45500, Greece
General University Hospital of Thessaloniki AXEPA /ID# 226630
Thessaloniki , 54636, Greece
Theageneio Anticancer Hospital /ID# 226627
Thessaloniki , 54639, Greece
Debreceni Egyetem Klinikai Kozpont /ID# 229287
Debrecen Hajdu-Bihar, 4032, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 246475
Kaposvár Somogy, 7400, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 232203
Nyiregyhaza Szabolcs-Szatmar-Bereg, 4400, Hungary
Markusovszky Egyetemi Oktatokorhaz /ID# 229290
Szombathely Vas, 9700, Hungary
Semmelweis Egyetem /ID# 229291
Budapest , 1085, Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 229286
Budapest , 1097, Hungary
Orszagos Onkologiai Intezet /ID# 229292
Budapest , 1122, Hungary
The Chaim Sheba Medical Center /ID# 228322
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 228529
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Assaf Harofeh Medical Center /ID# 228037
Be'Er Ya'Akov , 70300, Israel
Rambam Health Care Campus /ID# 227849
Haifa , 31096, Israel
Hadassah /ID# 227846
Jerusalem , 91120, Israel
Rabin Medical Center /ID# 228043
Petakh Tikva , 49414, Israel
Ziv Medical Center /ID# 232257
Safed , 13100, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 230402
Rome Lazio, 00168, Italy
IEO -Istituto Europeo di Oncologia /ID# 227396
Milan Milano, 20141, Italy
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 229602
Candiolo Torino, 10060, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 227401
Alessandria , 15121, Italy
ASST Spedali civili di Brescia /ID# 227397
Brescia , 25123, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 230403
Napoli , 80131, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 227399
Novara , 28100, Italy
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 227402
Palermo , 90146, Italy
Seoul National University Bundang Hospital /ID# 228448
Seongnam Gyeonggido, 13620, Korea, Republic of
Inje University Busan Paik Hospital /ID# 230293
Busan , 47392, Korea, Republic of
Dong-A University Hospital /ID# 228638
Busan , 49201, Korea, Republic of
Pusan National University Hospital /ID# 229798
Busan , 49241, Korea, Republic of
Keimyung University Dongsan Medical Center /ID# 229800
Daegu , 41931, Korea, Republic of
Jeonbuk National University Hospital /ID# 228908
Jeonju , 54907, Korea, Republic of
Seoul National University Hospital /ID# 228446
Seoul , 03080, Korea, Republic of
Asan Medical Center /ID# 228444
Seoul , 05505, Korea, Republic of
Samsung Medical Center /ID# 228445
Seoul , 06351, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 228447
Seoul , 06591, Korea, Republic of
Dijklander Ziekenhuis /ID# 248993
Hoorn Nh Noord-Holland, 1624 , Netherlands
Albert Schweitzer Ziekenhuis /ID# 247740
Dordrecht Zuid-Holland, 3318 , Netherlands
Onze Lieve Vrouwe Gasthuis /ID# 247899
Amsterdam , 1091 , Netherlands
Deventer Ziekenhuis /ID# 247853
Deventer , 7416 , Netherlands
Admiraal de Ruyter Ziekenhuis /ID# 247692
Goes , 4462 , Netherlands
Universitair Medisch Centrum Groningen /ID# 247741
Groningen , 9713 , Netherlands
St. Antonius Ziekenhuis /ID# 248644
Nieuwegein , 3435 , Netherlands
Franciscus Gasthuis & Vlietland /ID# 248139
Rotterdam , 3045 , Netherlands
Aotearoa Clinical Trials /ID# 228509
Papatoetoe Auckland, 2025, New Zealand
North Shore Hospital /ID# 228508
Takapuna Auckland, 0622, New Zealand
Palmerston North Hospital /ID# 232352
Palmerston North Manawatu-Wanganui, 4442, New Zealand
Pratia MCM Krakow /ID# 229121
Krakow Malopolskie, 30-72, Poland
Szpitale Pomorskie Sp. z o.o /ID# 229122
Gdynia Pomorskie, 81-51, Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 229362
Kielce Swietokrzyskie, 25-73, Poland
ARS-MEDICAL Sp. z o.o. /ID# 229601
Pila Wielkopolskie, 64-92, Poland
Centrum Medyczne Pratia Poznan /ID# 229299
Skorzewo Wielkopolskie, 60-18, Poland
Alberts Cellular Therapy /ID# 228896
Pretoria Gauteng, 0044, South Africa
Hospital Unversitario Marques de Valdecilla /ID# 228984
Santander Cantabria, 39008, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 228116
Pamplona Navarra, 31008, Spain
Hospital Parc de Salut del Mar /ID# 228106
Barcelona , 08003, Spain
Hospital Santa Creu i Sant Pau /ID# 229859
Barcelona , 08041, Spain
Hospital San Pedro de Alcantara /ID# 248845
Caceres , 10003, Spain
Hospital Universitario Reina Sofia /ID# 228122
Cordoba , 14004, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 229157
Madrid , 28027, Spain
Hospital Universitario Ramon y Cajal /ID# 228113
Madrid , 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 228110
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre /ID# 228109
Madrid , 28041, Spain
Hospital Universitario de Salamanca /ID# 228117
Salamanca , 37711, Spain
Hospital Universitario Virgen del Rocio /ID# 228118
Sevilla , 41013, Spain
Sunderby sjukhus /ID# 228165
Lulea Norrbottens Lan, 971 8, Sweden
Sodra Alvsborgs sjukhus /ID# 228886
Boras Vastra Gotalands Lan, 501 8, Sweden
Linkoping University Hospital /ID# 233520
Linkoping , 581 8, Sweden
Kantonsspital Aarau AG /ID# 229113
Aarau Aargau, 5001, Switzerland
Kantonsspital St. Gallen /ID# 229117
St. Gallen Sankt Gallen, 9007, Switzerland
EOC Ospedale Regionale di Bellinzona e Valli /ID# 228922
Bellinzona Ticino, 6500, Switzerland
Kaohsiung Chang Gung Memorial Hospital /ID# 227384
Kaohsiung City Kaohsiung, 833, Taiwan
China Medical University Hospital /ID# 227379
Taichung , 40447, Taiwan
Taichung Veterans General Hospital /ID# 227383
Taichung , 40705, Taiwan
National Cheng Kung University Hospital /ID# 227381
Tainan , 704, Taiwan
Ankara Universitesi Fakultesi /ID# 227790
Ankara , 06620, Turkey
Akdeniz Universitesi Tip Fakul /ID# 227791
Antalya , 07059, Turkey
Dicle Universitesi Tip /ID# 230087
Diyarbakir , 21200, Turkey
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 227855
Istanbul , 34899, Turkey
Ege University Medical Faculty /ID# 227792
Izmir , 35040, Turkey
Kocaeli University Med Faculty /ID# 227854
Kocaeli , 41380, Turkey
Ondokuz mayis University Facul /ID# 227794
Samsun , 55200, Turkey

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

642

Study ID:

NCT05409066

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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