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)

A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Follicular Lymphoma (FL)
• Intervention / Treatment: Drug: Epcoritamab; Drug: Rituximab; Drug: Lenalidomide

• Study Type: Interventional
• Enrollment (Actual): 549
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, 5016
    • Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 229701
  • Santa Fe, Argentina, 3000
    • Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 232124
  • Ciudad Autonoma de Buenos Aires
    • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma de Buenos Aires, Argentina, 1114
      • Fundaleu /Id# 229700
    • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma de Buenos Aires, Argentina, 1431
      • Duplicate_CEMIC /ID# 229697
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital /ID# 239272
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital /ID# 239093
  • Queensland
    • Douglas, Queensland, Australia, 4814
      • Townsville University Hospital /ID# 231124
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Peninsula Private Hospital /ID# 238796
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital /ID# 231122
    • Perth, Western Australia, Australia, 6000
      • Royal Perth Hospital /ID# 230456
    • Perth, Western Australia, Australia, 6009
      • Hollywood Private Hospital /ID# 251789
• Austria
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228366
  • Niederoesterreich
    • Sankt Poelten, Niederoesterreich, Austria, 3100
      • Universitaetsklinikum St. Poelten /ID# 234015
  • Oberoesterreich
    • Linz, Oberoesterreich, Austria, 4010
      • Ordensklinikum Linz GmbH Elisabethinen /ID# 247510
• Belgium
  • Anderlecht, Belgium, 1070
    • Institut Jules Bordet /ID# 254676
  • Liege, Belgium, 4000
    • Groupe Sante CHC - Clinique du MontLegia /ID# 230415
  • Turnhout, Belgium, 2300
    • AZ Turnhout - Campus Sint-Elisabeth /ID# 231628
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Uza /Id# 228521
  • Hainaut
    • La Louvière, Hainaut, Belgium, 7100
      • Hospital La Louviere Site Jolimont - Helora /ID# 228520
  • Oost-Vlaanderen
    • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
      • Vitaz /Id# 228525
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 247780
• Brazil
  • Rio de Janeiro, Brazil, 20231-050
    • Instituto Nacional de Cancer (INCA) /ID# 228706
  • Sao Paulo, Brazil, 01323-001
    • Real e Benemérita Associação Portuguesa de Beneficência /ID# 228121
  • Sao Paulo, Brazil, 01401-002
    • Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 252918
  • Sao Paulo, Brazil, 04039-901
    • Instituto de Assistencia Medica ao Servidor Publico Estadual /ID# 230182
  • Sao Paulo, Brazil, 05403-000
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 228127
  • Parana
    • Curitiba, Parana, Brazil, 80060-900
      • Hospital de Clinicas da Universidade Federal do Parana /ID# 228123
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil, 18618-686
      • Upeclin Fmb - Unesp /Id# 252912
    • Jaú, Sao Paulo, Brazil, 17210-070
      • Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 228129
    • São Paulo, Sao Paulo, Brazil, 01509-900
      • Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 228130
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute /ID# 249080
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 6V5
      • BC Cancer - Victoria /ID# 228850
  • Quebec
    • Levis, Quebec, Canada, G6V 3Z1
      • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229896
    • Quebec City, Quebec, Canada, G1J 1Z4
      • CHUQ- Hôpital de l'Enfant-Jesus /ID# 231537
    • Rimouski, Quebec, Canada, G5L 5T1
      • CISSSBSL -Hopital regional de Rimouski /ID# 229894
• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital /ID# 250517
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital /ID# 230885
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital /ID# 233919
    • Xiamen, Fujian, China, 361003
      • The First Affiliated Hospital of Xiamen University /ID# 238427
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center /ID# 231463
    • Guangzhou, Guangdong, China, 510120
      • Guangdong Provincial Peoples Hospital（Huifu Campus） /ID# 232512
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University /ID# 230383
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Fourth Hospital of Hebei Medical University /ID# 238657
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital /ID# 230459
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234153
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital /ID# 232255
  • Hunan
    • Changsha, Hunan, China, 410006
      • Hunan Cancer Hospital /ID# 232153
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University /ID# 232511
    • Xuzhou, Jiangsu, China, 221006
      • The Affiliated Hospital of Xuzhou Medical College /ID# 232513
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University /ID# 231047
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Provincial Cancer Hospital /ID# 232507
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University /ID# 232509
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital /ID# 238650
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Cancer Hospital /ID# 250475
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Tianjin Cancer Hospital /ID# 230876
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Yunnan Cancer Hospital /ID# 232062
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230390
    • Hangzhou, Zhejiang, China, 310009
      • The second affiliated hospital of Zhejiang University school of medicine /ID# 231250
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer hospital /ID# 231389
• Czechia
  • Prague, Czechia, 150 00
    • Duplicate_Fakultni Nemocnice v Motole /ID# 228272
  • Praha, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady /ID# 228564
  • Hradec Kralove
    • Hradec Králové, Hradec Kralove, Czechia, 500 05
      • Fakultní nemocnice Hradec Králové - Sokolská /ID# 228269
  • Praha 17
    • Praha, Praha 17, Czechia, 128 00
      • Všeobecná Fakultní Nemocnice v Praze /ID# 228565
• Denmark
  • Midtjylland
    • Herning, Midtjylland, Denmark, 7400
      • Regionshospitalet Godstrup /ID# 227466
  • Syddanmark
    • Vejle, Syddanmark, Denmark, 7100
      • Sygehus Lillebalt, Vejle /ID# 227404
• France
  • Caen, France, 14033
    • CHU de CAEN - Hopital de la Cote de Nacre /ID# 245929
  • Paris, France, 75010
    • Hôpital Saint-Louis /ID# 232067
  • Auvergne-Rhone-Alpes
    • Clermont, Auvergne-Rhone-Alpes, France, 63100
      • CHU Clermont-Ferrand /ID# 238676
  • Bretagne
    • Rennes, Bretagne, France, 35000
      • CHU de Rennes - PONTCHAILLOU /ID# 230356
  • Cote-d Or
    • Dijon, Cote-d Or, France, 21000
      • CHU Dijon /ID# 230354
  • Franche-Comte
    • Limoges CEDEX 1, Franche-Comte, France, 87042
      • CHU Limoges - Dupuytren 1 /ID# 231450
  • Gard
    • Nimes CEDEX 9, Gard, France, 30029
      • CHU NIMES - Hopital Caremeau /ID# 230351
  • Gironde
    • Pessac CEDEX, Gironde, France, 33604
      • Centre Hospitalier Universitaire de Bordeaux /ID# 230347
  • Ile-de-France
    • Paris Cedex 13, Ile-de-France, France, 75013
      • Hopital Pitie Salpetriere /ID# 230360
  • Marne
    • Reims CEDEX, Marne, France, 51092
      • CHU Reims - Hôpital Robert Debre /ID# 248710
  • Meurthe-et-Moselle
    • Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France, 54500
      • CHRU Nancy - Hopitaux de Brabois /ID# 241595
  • Nord
    • Lille, Nord, France, 59037
      • CHRU Lille - Hopital Claude Huriez /ID# 230353
  • Occitanie
    • Toulouse Cedex 9, Occitanie, France, 31059
      • IUCT Oncopole /ID# 233486
  • Paris
    • Creteil, Paris, France, 94010
      • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 230358
  • Pays-de-la-Loire
    • Nantes, Pays-de-la-Loire, France, 44000
      • CHU de Nantes, Hotel Dieu -HME /ID# 245928
  • Rhone
    • Lyon CEDEX 08, Rhone, France, 69373
      • Centre Leon Berard /ID# 230348
    • Pierre Benite CEDEX, Rhone, France, 69495
      • HCL - Hopital Lyon Sud /ID# 231449
  • Vendee
    • La Roche Sur Yon, Vendee, France, 85000
      • CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 234095
  • Vienne
    • Poitiers, Vienne, France, 86000
      • CHU Poitiers - La miletrie /ID# 230357
• Germany
  • Bamberg, Germany, 96049
    • Sozialstiftung Bamberg /ID# 229184
  • Berlin, Germany, 13125
    • Helios Klinikum Berlin-Buch /ID# 229178
  • Essen, Germany, 45147
    • Universitaetsklinikum Essen /ID# 229180
  • Trier, Germany, 54290
    • Klinikum Mutterhaus der Borromäerinnen /ID# 232354
  • Baden-Wuerttemberg
    • Tubingen, Baden-Wuerttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen /ID# 229663
  • Bayern
    • Wuerzburg, Bayern, Germany, 97080
      • Universitaetsklinikum Wuerzburg /ID# 229278
  • Hessen
    • Gießen, Hessen, Germany, 35392
      • Universitaetsklinikum Giessen /ID# 234245
    • Kassel, Hessen, Germany, 34125
      • Klinikum Kassel /ID# 229185
  • Niedersachsen
    • Goettingen, Niedersachsen, Germany, 37075
      • Universitaetsmedizin Goettingen /ID# 230411
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53127
      • Universitaetsklinikum Bonn /ID# 249401
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 229754
    • Leipzig, Sachsen, Germany, 04103
      • Universitaetsklinikum Leipzig /ID# 242907
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • Otto-von-Guericke-Universitaet /ID# 230144
  • Thueringen
    • Jena, Thueringen, Germany, 07747
      • Universitaetsklinikum Jena /ID# 232064
• Greece
  • Athens, Greece, 10676
    • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 226633
  • Ioannina, Greece, 45500
    • University General Hospital of Ioannina /ID# 226628
  • Thessaloniki, Greece, 54636
    • General University Hospital of Thessaloniki AXEPA /ID# 226630
  • Thessaloniki, Greece, 54639
    • Theageneio Anticancer Hospital /ID# 226627
  • Attiki
    • Athens, Attiki, Greece, 11527
      • General Hospital of Athens Laiko /ID# 226626
    • Athens, Attiki, Greece, 11528
      • Alexandra General Hospital /ID# 226632
    • Athens, Attiki, Greece, 12462
      • University General Hospital Attikon /ID# 226629
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 229291
  • Budapest, Hungary, 1097
    • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 229286
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet /ID# 229292
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem /ID# 229289
  • Hajdu-Bihar
    • Debrecen, Hajdu-Bihar, Hungary, 4032
      • Debreceni Egyetem-Klinikai Kozpont /ID# 229287
  • Somogy
    • Kaposvár, Somogy, Hungary, 7400
      • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246475
  • Szabolcs-Szatmar-Bereg
    • Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
      • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 232203
  • Vas
    • Szombathely, Vas, Hungary, 9700
      • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 229290
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 227849
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 228043
  • HaMerkaz
    • Zerifin, HaMerkaz, Israel, 70300
      • Yitzhak Shamir Medical Center /ID# 228037
  • HaTsafon
    • Safed, HaTsafon, Israel, 13100
      • ZIV Medical Center /ID# 232257
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 228322
    • Tel Aviv, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 228529
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 91120
      • Hadassah /ID# 227846
• Italy
  • Alessandria, Italy, 15100
    • Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Aless /ID# 227401
  • Bari, Italy, 70124
    • Duplicate_I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 227400
  • Brescia, Italy, 25123
    • ASST degli Spedali Civili di Brescia /ID# 227397
  • Napoli, Italy, 80131
    • Duplicate_Azienda Ospedaliera Universitaria Federico II /ID# 230403
  • Novara, Italy, 28100
    • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 227399
  • Palermo, Italy, 90146
    • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 227402
  • Ravenna, Italy, 48121
    • Ospedale Santa Maria Delle Croci /ID# 227394
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy, 71013
      • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 228458
  • Milano
    • Milan, Milano, Italy, 20132
      • IRCCS Ospedale San Raffaele /ID# 228669
    • Milan, Milano, Italy, 20141
      • Istituto Europeo Di Oncologia /ID# 227396
  • Piemonte
    • Torino, Piemonte, Italy, 10126
      • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229820
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Duplicate_Centro di Riferimento Oncologico /ID# 227395
  • Roma
    • Rome, Roma, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 230402
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 229602
• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital /ID# 230134
    • Nagoya-shi, Aichi, Japan, 460-0001
      • Duplicate_NHO Nagoya Medical Center /ID# 230678
    • Toyoake, Aichi, Japan, 470-1192
      • Fujita Health University Hospital /ID# 264541
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East /ID# 232423
  • Ehime
    • Matsuyama-shi, Ehime, Japan, 790-8524
      • Matsuyama Red Cross Hospital /ID# 251866
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 811-1395
      • National Hospital Organization Kyushu Cancer Center /ID# 252245
    • Fukuoka-shi, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital /ID# 230136
  • Fukushima
    • Fukushima-shi, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital /ID# 251839
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital /ID# 231443
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0047
      • Kobe City Medical Center General Hospital /ID# 251945
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 890-8520
      • Kagoshima University Hospital /ID# 232251
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1193
      • Tokai University Hospital /ID# 252135
    • Sagamihara-shi, Kanagawa, Japan, 252-0375
      • Kitasato University Hospital /ID# 264668
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 606-8507
      • Kyoto University Hospital /ID# 231156
  • Mie
    • Tsu-shi, Mie, Japan, 514-8507
      • Mie University Hospital /ID# 251944
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 9808574
      • Tohoku University Hospital /ID# 232303
  • Nagano
    • Matsumoto-shi, Nagano, Japan, 390-8621
      • Shinshu University Hospital /ID# 252246
  • Okayama
    • Okayama-shi, Okayama, Japan, 700-8558
      • Okayama University Hospital /ID# 232009
  • Osaka
    • Osaka-shi, Osaka, Japan, 534-0021
      • Osaka City General Hospital /ID# 264670
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital /ID# 232152
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital /ID# 230004
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital Of JFCR /ID# 230271
  • Yamagata
    • Yamagata-shi, Yamagata, Japan, 990-9585
      • Yamagata University Hospital /ID# 230005
  • Yamanashi
    • Kofu, Yamanashi, Japan, 400-0027
      • Yamanashi Prefectural Central Hospital /ID# 263715
• Korea, Republic of
  • Busan Gwang yeogsi
    • Busan, Busan Gwang yeogsi, Korea, Republic of, 47392
      • Inje University - Busan Paik Hospital /ID# 230293
    • Busan, Busan Gwang yeogsi, Korea, Republic of, 49201
      • Dong-A University Medical Center /ID# 228638
    • Busan, Busan Gwang yeogsi, Korea, Republic of, 49241
      • Pusan National University Hospital /ID# 229798
  • Gyeonggido
    • Seongnam-si, Gyeonggido, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital /ID# 228448
  • Gyeongsangbugdo
    • Daegu, Gyeongsangbugdo, Korea, Republic of, 42601
      • Keimyung University Dongsan Hospital /ID# 229800
  • Jeonrabugdo
    • Jeonju, Jeonrabugdo, Korea, Republic of, 54907
      • Jeonbuk National University Hospital /ID# 228908
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
      • Seoul National University Hospital /ID# 228446
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
      • Asan Medical Center /ID# 228444
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
      • Samsung Medical Center /ID# 228445
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
      • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 228447
• Netherlands
  • Deventer, Netherlands, 7416 SE
    • Deventer Ziekenhuis /ID# 247853
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen /ID# 247741
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6532 SZ
      • Canisius-Wilhelmina Ziekenhuis /ID# 248138
  • Noord-Brabant
    • Breda, Noord-Brabant, Netherlands, 4818 CK
      • Amphia Ziekenhuis /ID# 247739
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1091 AC
      • Olvg /Id# 247899
    • Hoorn Nh, Noord-Holland, Netherlands, 1624 NP
      • Dijklander Ziekenhuis /ID# 248993
  • Overijssel
    • Enschede, Overijssel, Netherlands, 7512 KZ
      • Medisch Spectrum Twente /ID# 247854
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • St. Antonius Ziekenhuis /ID# 248644
  • Zeeland
    • Goes, Zeeland, Netherlands, 4462 RA
      • Admiraal de Ruyter Ziekenhuis /ID# 247692
  • Zuid-Holland
    • Dordrecht, Zuid-Holland, Netherlands, 3318 AT
      • Albert Schweitzer Ziekenhuis /ID# 247740
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Leids Universitair Medisch Centrum /ID# 247742
    • Rotterdam, Zuid-Holland, Netherlands, 3045 PM
      • Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 248139
• New Zealand
  • Auckland
    • Papatoetoe, Auckland, New Zealand, 2025
      • Aotearoa Clinical Trials /ID# 228509
    • Takapuna, Auckland, New Zealand, 0622
      • North Shore Hospital /ID# 228508
  • Manawatu-Wanganui
    • Palmerston North, Manawatu-Wanganui, New Zealand, 4442
      • Palmerston North Hospital /ID# 232352
• Poland
  • Malopolskie
    • Krakow, Malopolskie, Poland, 30-727
      • Pratia MCM Krakow /ID# 229121
  • Pomorskie
    • Gdynia, Pomorskie, Poland, 81-519
      • Szpitale Pomorskie Sp. z o.o /ID# 229122
  • Swietokrzyskie
    • Kielce, Swietokrzyskie, Poland, 25-734
      • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 229362
  • Wielkopolskie
    • Pila, Wielkopolskie, Poland, 64-920
      • ARS-MEDICAL Sp. z o.o. /ID# 229601
    • Skorzewo, Wielkopolskie, Poland, 60-185
      • Aidport Sp. z o.o. /ID# 229299
• Puerto Rico
  • Manati, Puerto Rico, 00674
    • Hematology and Oncology Institute /ID# 230056
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials, LLC /ID# 230055
  • San Juan, Puerto Rico, 00918
    • Auxilio Mutuo Cancer Center /ID# 248721
• Slovakia
  • Bratislavsky kraj
    • Bratislava, Bratislavsky kraj, Slovakia, 833 10
      • Narodny onkologicky ustav /ID# 239510
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1864
      • Wits Clinical Research /ID# 228895
    • Pretoria, Gauteng, South Africa, 0044
      • Alberts Cellular Therapy /ID# 228896
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7925
      • University of Cape Town /ID# 228900
    • Kuilsrivier, Western Cape, South Africa, 7580
      • Haemalife Inc. /ID# 243392
• Spain
  • Barcelona, Spain, 08003
    • Hospital Parc de Salut del Mar /ID# 228106
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau /ID# 229859
  • Caceres, Spain, 10003
    • Hospital San Pedro de Alcantara /ID# 248845
  • Madrid, Spain, 28027
    • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 229157
  • Madrid, Spain, 28033
    • MD Anderson Madrid /ID# 229860
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal /ID# 228113
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz /ID# 228110
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 228109
  • Salamanca, Spain, 37711
    • Hospital Universitario de Salamanca /ID# 228117
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 228118
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Instituto Catalan de Oncologia (ICO) Badalona /ID# 228108
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 228107
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla /ID# 228984
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofia /ID# 228122
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra - Pamplona /ID# 228116
• Sweden
  • Norrbottens lan
    • Lulea, Norrbottens lan, Sweden, 971 80
      • Sunderby sjukhus /ID# 228165
  • Ostergotlands lan
    • Linkoping, Ostergotlands lan, Sweden, 581 85
      • Linkoping University Hospital /ID# 233520
  • Vastra Gotalands lan
    • Boras, Vastra Gotalands lan, Sweden, 501 82
      • Sodra Alvsborgs sjukhus /ID# 228886
• Switzerland
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Kantonsspital Aarau AG /ID# 229113
  • Graubuenden
    • Chur, Graubuenden, Switzerland, 7000
      • Kantonsspital Graubünden /ID# 253862
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen /ID# 229117
  • Ticino
    • Bellinzona, Ticino, Switzerland, 6500
      • EOC Ospedale Regionale di Bellinzona e Valli /ID# 228922
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital /ID# 227379
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital /ID# 227383
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital /ID# 227381
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 833
      • Kaohsiung Chang Gung Memorial Hospital /ID# 227384
• Turkey
  • Ankara, Turkey, 06620
    • Ankara Universitesi Fakultesi /ID# 227790
  • Antalya, Turkey, 07059
    • Akdeniz Universitesi Tip Fakul /ID# 227791
  • Diyarbakir, Turkey, 21200
    • Dicle Universitesi Tip /ID# 230087
  • Istanbul, Turkey, 34098
    • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 248202
  • Istanbul, Turkey, 34200
    • Istanbul Florence Nightingale Hastanesi /ID# 229546
  • Istanbul, Turkey, 34899
    • Duplicate_Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 227855
  • Izmir, Turkey, 35040
    • Ege University Medical Faculty /ID# 227792
  • Kocaeli, Turkey, 41380
    • Kocaeli University Med Faculty /ID# 227854
  • Samsun, Turkey, 55200
    • Ondokuz mayis University Facul /ID# 227794
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Foundation Trust /ID# 230043
  • Colchester, United Kingdom, CO4 5JL
    • East Suffolk and North Essex NHS Foundation Trust /ID# 230040
  • Liverpool, United Kingdom, L7 8YA
    • Clatterbridge Cancer Centre - Liverpool /ID# 230036
  • Manchester, United Kingdom, M20 4BX
    • The Christie Hospital /ID# 230124
  • Newcastle upon Tyne, United Kingdom, NE3 3HD
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 230123
  • Portsmouth, United Kingdom, PO6 3LY
    • Portsmouth Hospitals University NHS Trust /ID# 230044
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • Derriford Hospital and the Royal Eye Infirmary /ID# 230038
  • Glasgow City
    • Glasgow, Glasgow City, United Kingdom, G12 0YN
      • Gartnavel General Hospital /ID# 230027
  • Greater London
    • London, Greater London, United Kingdom, E1 2ES
      • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 230028
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Oxford University Hospitals NHS Foundation Trust /ID# 230035
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • Leeds Teaching Hospitals NHS Trust /ID# 230471
• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • The University of Arizona Cancer Center - North Campus /ID# 228862
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences /ID# 227198
  • California
    • Berkeley, California, United States, 94705
      • Alta Bates Summit Medical Center for Research /ID# 229428
    • Beverly Hills, California, United States, 90211
      • Beverly Hills Cancer Center /ID# 231535
    • Long Beach, California, United States, 90806-1701
      • Long Beach Memorial Medical Ct /ID# 228997
    • Los Angeles, California, United States, 90033
      • University of Southern California /ID# 227195
    • Los Angeles, California, United States, 90067
      • Valkyrie Clinical Trials /ID# 268502
  • Georgia
    • Atlanta, Georgia, United States, 30322-1013
      • Duplicate_Emory University /ID# 227299
  • Hawaii
    • Honolulu, Hawaii, United States, 96813-4920
      • Hawaii Cancer Care - Waterfront Plaza /ID# 262448
  • Illinois
    • Chicago, Illinois, United States, 60611-2927
      • Northwestern University Feinberg School of Medicine /ID# 227248
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Goshen Center for Cancer Care /ID# 227189
    • Indianapolis, Indiana, United States, 46250-2042
      • Community Health Network, Inc. /ID# 259756
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady Of The Lake Regional Medical Center /ID# 251393
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Baltimore /ID# 227191
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital /ID# 245233
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center /ID# 227323
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital /ID# 227250
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • St. Luke's Hospital - Chesterfield /ID# 247817
  • Montana
    • Billings, Montana, United States, 59102
      • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 251220
  • New Jersey
    • Morristown, New Jersey, United States, 07960-6136
      • Morristown Medical Center /ID# 231427
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute /ID# 239128
    • Mineola, New York, United States, 11501
      • NYU Langone Hospital - Long Island /ID# 253343
    • New York, New York, United States, 10016
      • NYU Laura and Isaac Perlmutter Cancer Center /ID# 227322
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai /ID# 227181
    • New York, New York, United States, 10065-6007
      • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University - Brody School of Medicine /ID# 227192
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104-5418
      • University of Oklahoma, Stephenson Cancer Center /ID# 227325
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Sammons Cancer Center /ID# 261584
    • Tyler, Texas, United States, 75702
      • Texas Oncology - Northeast Texas /ID# 265890
  • Utah
    • Salt Lake City, Utah, United States, 84143
      • Intermountain Healthcare LDS Hospital /ID# 259948
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University Medical Center Main Hospital /ID# 227211

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.
• Estimated Creatinine Clearance (CrCl) >= 50 mL/min.

Exclusion Criteria:

• Documented refractoriness to lenalidomide.
• Have lenalidomide exposure within 12 months prior to randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epcoritamab Dose A in Combination With R2; Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).	Drug: Epcoritamab; Subcutaneous Injection; Other Names: GEN3013; Drug: Rituximab; Intravenous Infusion; Drug: Lenalidomide; Oral Capsules
Active Comparator: Lenalidomide and Rituximab (R2); Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).	Drug: Rituximab; Intravenous Infusion; Drug: Lenalidomide; Oral Capsules
Experimental: Epcoritamab Dose B in Combination With R2; 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.	Drug: Epcoritamab; Subcutaneous Injection; Other Names: GEN3013; Drug: Rituximab; Intravenous Infusion; Drug: Lenalidomide; Oral Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	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).	Up to approximately 5 years
Percentage of Participants Achieving Best Overall Response (BOR)	BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria, as assessed by an IRC.	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival is defined as the duration from the date of randomization to the date of the participant's death.	Up to approximately 8 years from randomization
Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity	MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of subsequent anti-lymphoma therapy.	Up to approximately 5 years
Percentage of Participants Achieving CR	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.	Up to approximately 5 years
Change in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)	The objective of the FACT-Lym patient-reported outcome (PRO) is to address health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Like-type scale, with a higher score signifying a higher quality of life.	Up to approximately 8 years
PFS as Assessed by Investigator	PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by investigator or death (whichever occurs first).	Up to approximately 5 years
Percentage of Participants Achieving BOR as Assessed by Investigator	BOR is defined as CR PR, determined by Lugano criteria, as assessed by an investigator.	Up to approximately 5 years
Percentage of Participants Achieving CR as Assessed by Investigator	Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the investigator prior to the initiation of subsequent anti-lymphoma therapy.	Up to approximately 5 years
Duration of Response (DOR)	DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.	Up to approximately 8 years
Duration of Complete Response (DOCR)	DOR is defined as the time from the first occurrence of CR to disease progression or death, whichever occurs first.	Up to approximately 8 years
Time to Progression (TTP)	Time to progression is defined as the number of days from the date of study drug start to the date of the first documented disease progression or relapse.	Up to approximately 8 years
Time to Next Anti-Lymphoma Treatment (TTNLT)	Time to next anti-lymphoma treatment is defined as the number of days from the date of the first documented disease progression or relapse to the date of next anti-lymphoma treatment.	Up to approximately 8 years
Percentage of Participants Achieving CR at the End of Treatment	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.	Up to approximately 5 years
Time to Response (TTR)	Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.	Up to approximately 8 years
Time to Complete Response (TTCR)	Time to complete response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.	Up to approximately 8 years
Event-Free Survival (EFS)	EFS is defined as the duration from randomization to disease progression determined by Lugano criteria as assessed by the investigator, initiation of any non-protocol-specified new anti-lymphoma therapy for any reason, or death (whichever occurs first).	Up to approximately 8 years
Time to next anti-lymphoma treatment (TTNLT)		Up to approximately 8 years
Change in Patient's Global Impression of Severity (PGIS)	PGIS is a self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity. Participants rate their lymphoma symptoms severity as none, mild, moderate, severe, or very severe.	Up to approximately 8 years
Change in Patient's Global Impression of Change (PGIC)	PGIS is a self-report measure PGIC reflects a participant's belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement since start of treatment. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.	Up to approximately 8 years
Change in EuroQol 5-Dimension Questionnaire, 5-level (EQ-5D-5L)	The EQ-5D-5L descriptive system measures health status and comprises 5 health aspects including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each parameter has 5 response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. This instrument will not be administered during the Survival Follow-Up.	Up to approximately 8 years

Collaborators and Investigators

• Sponsor: Genmab
• Collaborators: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Lymphoma; Rituximab; Non-Hodgkin's lymphoma (NHL); Lenalidomide; Epcoritamab; Follicular Lymphoma (FL); EPCORE FL-1; EPCORE
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Follicular; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide; Rituximab
• Other Study ID Numbers: M20-638; 2023-505628-67 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes