A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) (EPCORE DLBCL-2)

A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally.

In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.

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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Study Overview

• Status: Active, not recruiting
• Conditions: Diffuse Large B-Cell Lymphoma
• Intervention / Treatment: Drug: Epcoritamab; Drug: Prednisone; Drug: Cyclophosphamide; Drug: Rituximab; Drug: Vincristine; Drug: Doxorubicin

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital /ID# 230072
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital /ID# 225683
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health - Monash Medical Centre /ID# 225680
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health /ID# 225716
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital /ID# 225999
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Perth Blood Institute Ltd /ID# 225679
    • Nedlands, Western Australia, Australia, 6009
      • Hollywood Private Hospital /ID# 251837
    • Perth, Western Australia, Australia, 6000
      • Royal Perth Hospital /ID# 226583
• Austria
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228360
  • Niederoesterreich
    • Sankt Poelten, Niederoesterreich, Austria, 3100
      • Universitaetsklinikum St. Poelten /ID# 234016
  • Wien
    • Vienna, Wien, Austria, 1160
      • Klinik Ottakring /ID# 243941
    • Vienna, Wien, Austria, 1090
      • Medizinische Universitaet Wien /ID# 252095
• Belgium
  • Anderlecht, Belgium, 1070
    • Institut Jules Bordet /ID# 225954
  • Brugge, Belgium, 8000
    • AZ Sint-Jan Brugge /ID# 225735
  • Antwerpen
    • Antwerp, Antwerpen, Belgium, 2020
      • Duplicate_ZAS Middelheim /ID# 225741
    • Antwerp, Antwerpen, Belgium, 2030
      • ZAS Cadix /ID# 264327
  • Bruxelles-Capitale
    • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
      • Cliniques Universitaires UCL Saint-Luc /ID# 225737
  • Hainaut
    • La Louvière, Hainaut, Belgium, 7100
      • Hospital La Louviere Site Jolimont - Helora /ID# 225738
  • Liege
    • Liège, Liege, Belgium, 4000
      • CHU de Liège /ID# 225952
  • Namur
    • Yvoir, Namur, Belgium, 5530
      • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 225742
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent /ID# 250031
    • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
      • Vitaz /Id# 226153
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 225951
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • AZ-Delta /ID# 225736
• Brazil
  • Rio de Janeiro, Brazil, 20231-050
    • Instituto Nacional de Cancer (INCA) /ID# 226026
  • Sao Paulo, Brazil, 01323-001
    • Real e Benemérita Associação Portuguesa de Beneficência /ID# 226023
  • Sao Paulo, Brazil, 01323-020
    • Hospital Alemao Oswaldo Cruz /ID# 252833
  • Sao Paulo, Brazil, 01401-002
    • Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 262394
  • Sao Paulo, Brazil, 05403-000
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 226048
  • Parana
    • Curitiba, Parana, Brazil, 80060-900
      • Hospital de Clinicas da Universidade Federal do Parana /ID# 226027
  • Sao Paulo
    • Jaú, Sao Paulo, Brazil, 17210-070
      • Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 226065
    • São Paulo, Sao Paulo, Brazil, 01509-900
      • Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 226809
    • São Paulo, Sao Paulo, Brazil, 05652-900
      • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 252832
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • UMHAT Sveti Georgi /ID# 245780
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda University Hospital EAD /ID# 244616
  • Sofia, Bulgaria, 1431
    • UMHAT Sveti Ivan Rilski /ID# 244615
  • Sofia, Bulgaria, 1797
    • SHAT Hematologic Diseases /ID# 250102
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Arthur J.E. Child Comprehensive Cancer Centre Pharmacy /ID# 226077
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1L3
      • BC Cancer - Vancouver /ID# 230573
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • William Osler Health System /ID# 250973
    • Hamilton, Ontario, Canada, L8V 1C3
      • Juravinski Cancer Centre /ID# 226084
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre /ID# 226082
• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital /ID# 229819
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital /ID# 230975
    • Beijing, Beijing, China, 100071
      • The Fifth Medical Center of PLA General Hospital /ID# 230941
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Provincial Cancer Hospital /ID# 238430
    • Xiamen, Fujian, China, 361003
      • The First Affiliated Hospital of Xiamen University /ID# 238426
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center /ID# 238371
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital /ID# 230945
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University /ID# 238436
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Fourth Hospital of Hebei Medical University /ID# 238656
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital /Id# 241755
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital /ID# 230398
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234152
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital /ID# 232256
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University /ID# 232569
    • Xuzhou, Jiangsu, China, 221006
      • The Affiliated Hospital of Xuzhou Medical College /ID# 233174
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University /ID# 230399
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Provincial Cancer Hospital /ID# 233379
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University /ID# 239618
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University /ID# 233201
  • Shandong
    • Jinan, Shandong, China, 251601
      • Shandong Cancer Hospital /ID# 233200
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Cancer Hospital /ID# 251516
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Shanxi Provincial Cancer Hospital /ID# 250745
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Tianjin Cancer Hospital /ID# 230974
    • Tianjin, Tianjin, China, 300020
      • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 259904
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer hospital /ID# 231388
    • Hangzhou, Zhejiang, China, 310009
      • The second affiliated hospital of Zhejiang University school of medicine /ID# 231249
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230387
• Croatia
  • Slavonski Brod, Croatia, 35000
    • Opca bolnica Dr. Josip Bencevic /ID# 251812
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Clinical Hospital Dubrava /ID# 251809
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinicka bolnica Merkur /ID# 252481
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinicki bolnicki centar Zagreb /ID# 250709
  • Primorsko-goranska Zupanija
    • Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
      • Klinicki bolnicki centar Rijeka /ID# 251811
  • Splitsko-dalmatinska Zupanija
    • Split, Splitsko-dalmatinska Zupanija, Croatia, 21000
      • Klinicki Bolnicki Centar (KBC) Split /ID# 250729
• Czechia
  • Prague, Czechia, 150 00
    • Duplicate_Fakultni Nemocnice v Motole /ID# 225958
  • Praha, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady /ID# 225956
  • Praha, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze /ID# 225396
  • Brno-mesto
    • Brno, Brno-mesto, Czechia, 625 00
      • Fakultní Nemocnice Brno - Jihlavská /ID# 225953
  • Hradec Kralove
    • Hradec Králové, Hradec Kralove, Czechia, 500 05
      • Fakultní nemocnice Hradec Králové - Sokolská /ID# 225955
  • Ostrava-mesto
    • Ostrava, Ostrava-mesto, Czechia, 708 52
      • Fakultni Nemocnice Ostrava /ID# 225957
• Denmark
  • Hovedstaden
    • Copenhagen Ø, Hovedstaden, Denmark, 2100
      • Rigshospitalet /ID# 226576
  • Midtjylland
    • Aarhus, Midtjylland, Denmark, 8200
      • Aarhus Universitetshospital - Skejby /ID# 226594
  • Sjælland
    • Roskilde, Sjælland, Denmark, 4000
      • Roskilde Sygehus /ID# 226597
  • Syddanmark
    • Odense, Syddanmark, Denmark, 5000
      • Odense University Hospital /ID# 226593
    • Vejle, Syddanmark, Denmark, 7100
      • Sygehus Lillebalt, Vejle /ID# 226592
• France
  • Angers, France, 49933
    • Chu Angers /Id# 245931
  • Caen, France, 14033
    • CHU de CAEN - Hopital de la Cote de Nacre /ID# 226582
  • Paris, France, 75010
    • Hôpital Saint-Louis /ID# 226126
  • Saint-cloud, France, 92210
    • Institut Curie - site CLCC René Huguenin /ID# 253519
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06200
      • CHU de Nice - Hôpital Archet 1 /ID# 226127
  • Auvergne-Rhone-Alpes
    • Clermont, Auvergne-Rhone-Alpes, France, 63100
      • CHU Clermont-Ferrand /ID# 229283
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13009
      • Institut Paoli-Calmettes /ID# 226557
  • Bretagne
    • Rennes, Bretagne, France, 35000
      • CHU de Rennes - PONTCHAILLOU /ID# 228207
  • Cote-d Or
    • Dijon, Cote-d Or, France, 21000
      • CHU Dijon /ID# 238345
  • Franche-Comte
    • Limoges CEDEX 1, Franche-Comte, France, 87042
      • CHU Limoges - Dupuytren 1 /ID# 234235
  • Herault
    • Montpellier Cedex 5, Herault, France, 34295
      • CHU Montpellier - Hopital Saint Eloi /ID# 228191
  • Ile-de-France
    • Paris, Ile-de-France, France, 75013
      • Hopital Pitie Salpetriere /ID# 238343
  • Isere
    • La Tronche, Isere, France, 38700
      • CHU Grenoble - Hopital Michallon /ID# 226128
  • Meurthe-et-Moselle
    • Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France, 54500
      • CHRU Nancy - Hopitaux de Brabois /ID# 226102
  • Nord
    • Lille, Nord, France, 59037
      • CHRU Lille - Hopital Claude Huriez /ID# 226101
  • Paris
    • Creteil, Paris, France, 94010
      • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 226560
  • Pays-de-la-Loire
    • Nantes, Pays-de-la-Loire, France, 44000
      • CHU de Nantes, Hotel Dieu -HME /ID# 226125
  • Pyrenees-Atlantiques
    • Bayonne, Pyrenees-Atlantiques, France, 64100
      • Centre Hospitalier de la Cote Basque /ID# 249143
  • Rhone
    • Pierre Benite CEDEX, Rhone, France, 69495
      • HCL - Hopital Lyon Sud /ID# 227086
  • Seine-Maritime
    • Rouen, Seine-Maritime, France, 76038
      • Centre Henri Becquerel /ID# 226103
  • Somme
    • Amiens CEDEX 1, Somme, France, 80054
      • CHU Amiens-Picardie Site Sud /ID# 238347
  • Vendee
    • La Roche Sur Yon, Vendee, France, 85000
      • CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 243899
  • Vienne
    • Poitiers, Vienne, France, 86000
      • CHU Poitiers - La miletrie /ID# 226578
• Greece
  • Athens, Greece, 10676
    • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 225416
  • Ioannina, Greece, 45500
    • University General Hospital of Ioannina /ID# 225400
  • Thessaloniki, Greece, 54636
    • General University Hospital of Thessaloniki AXEPA /ID# 225398
  • Thessaloniki, Greece, 54639
    • Theageneio Anticancer Hospital /ID# 225516
  • Attiki
    • Athens, Attiki, Greece, 11527
      • General Hospital of Athens Laiko /ID# 225399
    • Athens, Attiki, Greece, 11528
      • Alexandra General Hospital /ID# 225402
    • Athens, Attiki, Greece, 12462
      • University General Hospital Attikon /ID# 225401
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 227239
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet /ID# 227294
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem /ID# 226838
  • Gyor-Moson-Sopron
    • Gyor, Gyor-Moson-Sopron, Hungary, 9024
      • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 257189
  • Hajdu-Bihar
    • Debrecen, Hajdu-Bihar, Hungary, 4032
      • Debreceni Egyetem-Klinikai Kozpont /ID# 226821
  • Somogy
    • Kaposvár, Somogy, Hungary, 7400
      • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245938
  • Tolna
    • Szekszard, Tolna, Hungary, 7100
      • Tolna Varmegyei Balassa Janos Korhaz /ID# 250063
  • Vas
    • Szombathely, Vas, Hungary, 9700
      • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 226846
• Israel
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 225862
  • H_efa
    • Haifa, H_efa, Israel, 3109601
      • Rambam Health Care Campus /ID# 225981
  • HaMerkaz
    • Kfar Saba, HaMerkaz, Israel, 4428164
      • Meir Medical Center /ID# 225612
    • Tel Aviv, HaMerkaz, Israel, 6971028
      • Assuta Tel Aviv Medical Center /ID# 226066
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 225600
    • Tel Aviv, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 225891
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 91031
      • Shaare Zedek Medical Center /ID# 259796
    • Jerusalem, Yerushalayim, Israel, 91120
      • Hadassah /ID# 225614
• Italy
  • Alessandria, Italy, 15100
    • Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Aless /ID# 225542
  • Bari, Italy, 70124
    • I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 225548
  • Brescia, Italy, 25123
    • Duplicate_ASST Spedali civili di Brescia /ID# 225549
  • Novara, Italy, 28100
    • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 225773
  • Palermo, Italy, 90146
    • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 225541
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana /ID# 225575
  • Ravenna, Italy, 48121
    • Ospedale Santa Maria Delle Croci /ID# 225571
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 225551
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy, 71013
      • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 225554
  • Milano
    • Milan, Milano, Italy, 20132
      • IRCCS Ospedale San Raffaele /ID# 225555
    • Milan, Milano, Italy, 20141
      • Istituto Europeo Di Oncologia /ID# 225545
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Azienda Ospedaliera Universitaria Federico II /ID# 225543
  • Piemonte
    • Torino, Piemonte, Italy, 10126
      • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 225775
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Duplicate_Centro di Riferimento Oncologico /ID# 225553
  • Reggio Emilia
    • Meldola, Reggio Emilia, Italy, 47014
      • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 252192
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 225751
• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 460-0001
      • NHO Nagoya Medical Center /ID# 230677
    • Nagoya-shi, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital /ID# 226090
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East /ID# 250151
  • Ehime
    • Matsuyama-shi, Ehime, Japan, 790-8524
      • Matsuyama Red Cross Hospital /ID# 251068
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital /ID# 226091
    • Fukuoka-shi, Fukuoka, Japan, 811-1395
      • National Hospital Organization Kyushu Cancer Center /ID# 251622
  • Fukushima
    • Fukushima-shi, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital /ID# 250869
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 060-8648
      • Duplicate_Hokkaido University Hospital /ID# 250149
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0047
      • Kobe City Medical Center General Hospital /ID# 250597
  • Ibaraki
    • Tsukuba-shi, Ibaraki, Japan, 305-8576
      • University of Tsukuba Hospital /ID# 251282
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital /ID# 251770
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 890-8520
      • Kagoshima University Hospital /ID# 250163
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1193
      • Tokai University Hospital /ID# 251281
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 9808574
      • Tohoku University Hospital /ID# 250150
  • Okayama
    • Okayama-shi, Okayama, Japan, 700-8558
      • Okayama University Hospital /ID# 250161
  • Osaka
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital /ID# 250160
    • Suita-shi, Osaka, Japan, 565-0871
      • Osaka University Hospital /ID# 251283
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital /ID# 226089
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital Of JFCR /ID# 230269
  • Yamagata
    • Yamagata-shi, Yamagata, Japan, 990-9585
      • Yamagata University Hospital /ID# 230003
• Korea, Republic of
  • Busan Gwang Yeogsi
    • Busan, Busan Gwang Yeogsi, Korea, Republic of, 47392
      • Inje University - Busan Paik Hospital /ID# 232262
  • Gyeonggido
    • Seongnam-si, Gyeonggido, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital /ID# 225763
  • Gyeongsangbugdo
    • Daegu, Gyeongsangbugdo, Korea, Republic of, 42601
      • Keimyung University Dongsan Hospital /ID# 232264
  • Gyeongsangnamdo
    • Busan, Gyeongsangnamdo, Korea, Republic of, 49201
      • Dong-A University Medical Center /ID# 228451
  • Jeonrabugdo
    • Jeonju, Jeonrabugdo, Korea, Republic of, 54907
      • Jeonbuk National University Hospital /ID# 232263
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
      • Seoul National University Hospital /ID# 225760
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
      • Asan Medical Center /ID# 225758
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
      • Samsung Medical Center /ID# 225759
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
      • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 225761
  • Ulsan Gwang Yeogsi
    • Ulsan, Ulsan Gwang Yeogsi, Korea, Republic of, 44033
      • Ulsan University Hospital /ID# 226971
• Netherlands
  • Den Haag, Netherlands, 2512 VA
    • Haaglanden Medisch Centrum /ID# 229686
  • Deventer, Netherlands, 7416 SE
    • Deventer Ziekenhuis /ID# 229937
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen /ID# 225602
  • S Hertogenbosch, Netherlands, 5223 GZ
    • Jeroen Bosch Ziekenhuis /ID# 229765
  • Utrecht, Netherlands, 3582 KE
    • Diakonessenhuis /ID# 251793
  • Flevoland
    • Almere, Flevoland, Netherlands, 1315 RA
      • Flevo Ziekenhuis /ID# 229606
  • Friesland
    • Leeuwarden, Friesland, Netherlands, 8934 AD
      • Medisch Centrum Leeuwarden /ID# 225605
  • Gelderland
    • Apeldoorn, Gelderland, Netherlands, 7334 DZ
      • Gelre Ziekenhuizen /ID# 229762
    • Nijmegen, Gelderland, Netherlands, 6532 SZ
      • Canisius-Wilhelmina Ziekenhuis /ID# 231291
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht Universitair Medisch Centrum /ID# 225607
  • Noord-Brabant
    • Breda, Noord-Brabant, Netherlands, 4818 CK
      • Amphia Ziekenhuis /ID# 229550
    • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
      • Catharina Ziekenhuis /ID# 230465
    • Eindhoven, Noord-Brabant, Netherlands, 5631 BM
      • Maxima Medisch Centrum /ID# 225603
    • Tilburg, Noord-Brabant, Netherlands, 5022 GC
      • Elisabeth Tweesteden Ziekenhuis /ID# 229773
  • Noord-Holland
    • Alkmaar, Noord-Holland, Netherlands, 1815 JD
      • Noordwest Ziekenhuisgroep /ID# 230613
    • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • Vrije Universiteit Medisch Centrum /ID# 225608
    • Amsterdam, Noord-Holland, Netherlands, 1091 AC
      • Olvg /Id# 229761
    • Haarlem, Noord-Holland, Netherlands, 2035 RC
      • Spaarne Gasthuis, Haarlem Zuid /ID# 229621
    • Hilversum, Noord-Holland, Netherlands, 1213 XZ
      • Tergooi /ID# 229772
    • Hoorn Nh, Noord-Holland, Netherlands, 1624 NP
      • Dijklander Ziekenhuis /ID# 229900
    • Zaandam, Noord-Holland, Netherlands, 1502 DV
      • Zaans Medisch Centrum /ID# 230614
  • Overijssel
    • Enschede, Overijssel, Netherlands, 7512 KZ
      • Medisch Spectrum Twente /ID# 225610
  • Utrecht
    • Amersfoort, Utrecht, Netherlands, 3813 TZ
      • Meander Medisch Centrum /ID# 229608
    • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • St. Antonius Ziekenhuis /ID# 229901
  • Zuid-Holland
    • Dordrecht, Zuid-Holland, Netherlands, 3318 AT
      • Albert Schweitzer Ziekenhuis /ID# 229560
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Leids Universitair Medisch Centrum /ID# 225606
• New Zealand
  • Auckland
    • Takapuna, Auckland, New Zealand, 0622
      • North Shore Hospital /ID# 250992
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • Christchurch Hospital /ID# 250993
• Poland
  • Pomorskie
    • Slupsk, Pomorskie, Poland, 76-200
      • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka /ID# 228723
  • Swietokrzyskie
    • Kielce, Swietokrzyskie, Poland, 25-734
      • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 225986
  • Warminsko-mazurskie
    • Olsztyn, Warminsko-mazurskie, Poland, 10-228
      • Szpital Kliniczny MSWiA z Warminsko-Mazurskim Centrum Onkologii /ID# 225985
  • Wielkopolskie
    • Pila, Wielkopolskie, Poland, 64-920
      • ARS-MEDICAL Sp. z o.o. /ID# 225848
    • Skorzewo, Wielkopolskie, Poland, 60-185
      • Centrum Medyczne Pratia Poznan /ID# 227236
• Portugal
  • Braga, Portugal, 4710-243
    • 2CA-Braga, Hospital de Braga /ID# 249112
  • Lisboa, Portugal, 1099-023
    • IPO Lisboa FG, EPE /ID# 249109
  • Lisboa, Portugal, 1649-035
    • Unidade Local de Saude de Santa Maria, EPE /ID# 249111
  • Porto, Portugal, 4200-072
    • IPO Porto FG, EPE /ID# 249110
• Puerto Rico
  • Curitiba, Puerto Rico, 81520-060
    • Hospital Erasto Gaertner /ID# 262593
  • Manati, Puerto Rico, 00674
    • Hematology and Oncology Institute /ID# 230054
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials, LLC /ID# 230052
• Slovakia
  • Bratislavsky Kraj
    • Bratislava, Bratislavsky Kraj, Slovakia, 833 10
      • Narodny onkologicky ustav /ID# 238847
  • Zilinsky Kraj
    • Martin, Zilinsky Kraj, Slovakia, 036 01
      • Univerzitna nemocnica Martin /ID# 240828
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1864
      • Wits Clinical Research /ID# 227799
    • Johannesburg, Gauteng, South Africa, 1864
      • Wits Clinical Research /ID# 227803
    • Pretoria, Gauteng, South Africa, 0044
      • Alberts Cellular Therapy /ID# 227798
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7925
      • University of Cape Town /ID# 227802
    • Kuilsrivier, Western Cape, South Africa, 7580
      • Haemalife Inc. /ID# 243391
• Spain
  • Barcelona, Spain, 08003
    • Hospital Parc de Salut del Mar /ID# 225810
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 225811
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau /ID# 225813
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 226651
  • Madrid, Spain, 28027
    • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 228228
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor /ID# 225816
  • Madrid, Spain, 28033
    • MD Anderson Madrid /ID# 225817
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal /ID# 241750
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz /ID# 225804
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 225815
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia /ID# 225818
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Instituto Catalan de Oncologia (ICO) Badalona /ID# 228063
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 227393
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofia /ID# 225806
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Clinico Universitario Virgen de la Arrixaca /ID# 255381
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra - Pamplona /ID# 225809
• Sweden
  • Ostergotlands Lan
    • Linkoping, Ostergotlands Lan, Sweden, 581 85
      • Linkoping University Hospital /ID# 233521
  • Skane Lan
    • Lund, Skane Lan, Sweden, 224 84
      • Skane University Hospital Lund /ID# 227285
  • Stockholms Lan
    • Solna, Stockholms Lan, Sweden, 171 64
      • Karolinska University Hospital Solna /ID# 229284
  • Vastra Gotalands Lan
    • Boras, Vastra Gotalands Lan, Sweden, 501 82
      • Sodra Alvsborgs sjukhus /ID# 228885
    • Göteborg, Vastra Gotalands Lan, Sweden, 413 46
      • Sahlgrenska Universitetssjukhuset /ID# 250089
• Switzerland
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Kantonsspital Aarau AG /ID# 229112
  • Bern
    • Thun, Bern, Switzerland, 3600
      • Spital Thun /ID# 229499
  • Zuerich
    • Winterthur, Zuerich, Switzerland, 8400
      • KSW Kantonsspital Winterthur /ID# 241631
• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital /ID# 226674
  • Taichung, Taiwan, 40447
    • China Medical University Hospital /ID# 226188
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital /ID# 226671
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 833
      • Kaohsiung Chang Gung Memorial Hospital /ID# 226670
• Turkey
  • Ankara, Turkey, 06620
    • Ankara Universitesi Fakultesi /ID# 227331
  • Malatya, Turkey, 44280
    • Inonu University Medical Faculty /ID# 226572
  • Samsun, Turkey, 55139
    • Ondokuz Mayis Universitesi /ID# 251247
  • Trabzon, Turkey, 61000
    • Karadeniz University /ID# 226573
  • Yuregir, Turkey, 01240
    • Baskent Universitesi Adana Uyg. ve Arast. Merkezi Yuregir Baskent Hastanesi /ID# 225921
  • Kocaeli
    • Dilovası, Kocaeli, Turkey, 41455
      • Anadolu Saglik Merkezi /ID# 225777
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Foundation Trust /ID# 229197
  • Edinburgh, United Kingdom, EH3 9HE
    • NHS Lothian /ID# 229055
  • England
    • London, England, United Kingdom, W12 0HS
      • Hammersmith Hospital /ID# 242215
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 226692
• United States
  • Arizona
    • Tucson, Arizona, United States, 85719-1478
      • University of Arizona Cancer Center - North Campus /ID# 227463
    • Yuma, Arizona, United States, 85364
      • Yuma Regional Medical Center /ID# 261527
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences /ID# 225703
  • California
    • Bakersfield, California, United States, 93309
      • CBCC Global Research, Inc. /ID# 262037
    • Berkeley, California, United States, 94705
      • Alta Bates Summit Medical Center for Research /ID# 229427
    • Fountain Valley, California, United States, 92708
      • Orange Coast Memorial Medical Center /ID# 229632
    • Fullerton, California, United States, 92835
      • Providence - St. Jude Medical Center /ID# 262042
    • Laguna Hills, California, United States, 92653-3689
      • Saddleback Memorial Medical Center /ID# 229631
    • Long Beach, California, United States, 90806-1701
      • Long Beach Memorial Medical Ct /ID# 228996
    • Los Alamitos, California, United States, 90720-3309
      • Cancer and Blood Speciality Clinic - Los Alamitos /ID# 262032
    • Los Angeles, California, United States, 90033
      • University of Southern California /ID# 225443
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles /ID# 226887
  • Colorado
    • Aurora, Colorado, United States, 80014
      • Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228618
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida /ID# 226826
    • Ocala, Florida, United States, 34474-4445
      • Ocala Oncology Florida Cancer Affiliates - Main /ID# 262785
    • Orlando, Florida, United States, 32806
      • Orlando Health Cancer Institute /ID# 232626
  • Hawaii
    • Honolulu, Hawaii, United States, 96813-3097
      • Straub Medical Center /ID# 229464
  • Illinois
    • Chicago, Illinois, United States, 60607
      • University of Illinois at Chicago /ID# 226889
    • Springfield, Illinois, United States, 62702
      • Southern IL Univ School of Med /ID# 228999
    • Springfield, Illinois, United States, 62703-2403
      • Springfield Clinic Main Campus /ID# 262584
    • Urbana, Illinois, United States, 61801-1645
      • Carle Cancer Institute /ID# 228338
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Comprehensive Cancer Center /ID# 227026
    • Goshen, Indiana, United States, 46526
      • Goshen Center for Cancer Care /ID# 225534
  • Iowa
    • Des Moines, Iowa, United States, 50314-3017
      • University of Iowa Health Care /ID# 261945
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas /ID# 261983
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute - St. Matthews /ID# 225420
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Baltimore /ID# 225421
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital /ID# 225369
    • Bethesda, Maryland, United States, 20817
      • American Oncology Partners of Maryland /ID# 226859
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center /ID# 226939
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 225462
    • Ypsilanti, Michigan, United States, 48197-1051
      • Trinity Health St. Joseph Mercy Ann Arbor /ID# 228206
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 226680
  • Mississippi
    • Jackson, Mississippi, United States, 39216-4500
      • University of Mississippi Medical Center /ID# 228045
  • Montana
    • Billings, Montana, United States, 59102
      • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 259014
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • NHO Revive Research Institute, LLC /ID# 261113
  • New Jersey
    • Camden, New Jersey, United States, 08103-1461
      • MDACC Cooper /ID# 260320
    • East Brunswick, New Jersey, United States, 08816
      • Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 226654
    • Morristown, New Jersey, United States, 07960-6136
      • Morristown Medical Center /ID# 239457
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102-4517
      • University of New Mexico /ID# 227332
    • Albuquerque, New Mexico, United States, 87110
      • Presbyterian Kaseman Hospital /ID# 262084
    • Rio Rancho, New Mexico, United States, 87124
      • Presbyterian Rust Medical Center /ID# 262068
  • New York
    • Bronx, New York, United States, 10469
      • New York Cancer and Blood Specialists- Eastchester, Bronx /ID# 265396
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute /ID# 239127
    • Mineola, New York, United States, 11501
      • NYU Langone Hospital - Long Island /ID# 262412
    • New Hyde Park, New York, United States, 11042
      • New York Cancer and Blood Specialists- New Hyde Park /ID# 265392
    • New York, New York, United States, 10016-4744
      • NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 226141
    • New York, New York, United States, 10065-6007
      • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 225379
    • New York, New York, United States, 10028
      • New York Cancer and Blood Specialists- Manhattan /ID# 265391
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai /ID# 225370
    • Port Jefferson Station, New York, United States, 11776-8060
      • New York Cancer and Blood Specialists /ID# 261114
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Presbyterian Medical Center /ID# 227753
    • Greenville, North Carolina, United States, 27834
      • East Carolina University - Brody School of Medicine /ID# 225992
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center /ID# 228339
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati /ID# 225374
    • Columbus, Ohio, United States, 43214-3908
      • OhioHealth Arthur G.H. Bing, MD Cancer Center /ID# 260790
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104-5418
      • University of Oklahoma, Stephenson Cancer Center /ID# 225556
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente - Northwest /ID# 225488
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital /ID# 258957
    • Kingwood, Texas, United States, 77339-6008
      • Millennium Research & Clinical Development /ID# 228284
    • Lubbock, Texas, United States, 79410
      • Joe Arrington Cancer Research /ID# 227217
    • Temple, Texas, United States, 76508-0001
      • Baylor Scott & White Medical Center- Temple /ID# 225935
  • Utah
    • Murray, Utah, United States, 84107-5701
      • Intermountain Medical Center /ID# 231184
  • Virginia
    • Charlottesville, Virginia, United States, 22903-3363
      • University of Virginia Cancer Center - West Complex /ID# 225433
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University Medical Center Main Hospital /ID# 225796
  • Washington
    • Olympia, Washington, United States, 98506-5028
      • Vista Oncology - East Olympia /ID# 229375
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute for Research & Innovation /ID# 225432
    • Tacoma, Washington, United States, 98405
      • MultiCare Regional Cancer Center - Tacoma /ID# 265285

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.

• Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:

  • DLBCL, Not Otherwise Specified (NOS).
  • High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
  • T-cell/histiocyte-rich large B-cell lymphoma.
  • Epstein Barr virus-positive DLBCL, NOS.
  • Follicular lymphoma Grade 3b.

Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.

Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.

• Availability of archival or fresh or paraffin embedded tissue at Screening.
• Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
• Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.

• Has at least one target lesion defined as:

  • >= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). AND
  • Positron emission tomography (PET)-positive on PET-CT scan.
• Laboratory values meeting the criteria laid out in the protocol.
• Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.

Exclusion Criteria:

• History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
• Clinically significant cardiovascular disease as per the protocol.

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epcoritamab and R-CHOP; Participants will receive subcutaneous epcoritamab combined with intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.	Drug: Epcoritamab; Subcutaneous Injection (SC); Other Names: ABBV-GMAB-3013; Drug: Prednisone; Oral; Tablet; Drug: Cyclophosphamide; Intravenous (IV) Injection; Drug: Rituximab; IV Infusion; Drug: Vincristine; IV Infusion; Drug: Doxorubicin; IV Infusion
Experimental: R-CHOP and Rituximab; Participants will receive intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by intravenous rituximab in 21-day cycles.	Drug: Prednisone; Oral; Tablet; Drug: Cyclophosphamide; Intravenous (IV) Injection; Drug: Rituximab; IV Infusion; Drug: Vincristine; IV Infusion; Drug: Doxorubicin; IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5	PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC), or death due to any cause whichever comes first.	Up to Approximately 46 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with PFS	PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by IRC, or death due to any cause, whichever occurs first.	Up to Approximately 46 Months
Number of Participants with Event-free survival (EFS)	EFS is defined as the duration from randomization to the date of disease progression determined by Lugano criteria as assessed by IRC, IRC-assessed PR or SD followed by non protocol-specified NALT, a positive biopsy on or after end-of-treatment (EOT), regardless of whether NAL initiated, or death from any cause.	Up to Approximately 46 Months
Overall survival (OS)	OS is defined as time from randomization until death due to any causes.	Up to Approximately 76 Months
Percentage of Participants with Minimal Residual Disease (MRD) Negativity	The MRD negativity rate is defined as the percentage of participants who achieve MRD negativity prior to the initiation of any non-protocol-specified new anti-lymphoma therapy.	Up to Approximately 46 Months
Percentage of Participants with Complete Remission (CR)	CR on or after EOT, determined by Lugano 2014 criteria as assessed by IRC.	On or After to Approximately 28 Weeks

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): February 8, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Rituximab; R-CHOP; Relapsed or Refractory Diffuse Large B-Cell Lymphoma; Non-Hodgkins Lymphoma; Epcoritamab; ABBV-GMAB-3013; EPCORE
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Antineoplastic Agents, Immunological; Antibiotics, Antineoplastic; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Enzyme Inhibitors; Antirheumatic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase Inhibitors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Rituximab; Prednisone; Cyclophosphamide; Doxorubicin; Vincristine
• Other Study ID Numbers: M20-621; 2023-505277-32 (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 (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• 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