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)

September 9, 2026 updated by: Genmab

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
    • Lower Austria
      • Sankt Pölten, Lower Austria, Austria, 3100
        • Universitaetsklinikum St. Poelten /ID# 234016
    • State of Salzburg
      • Salzburg, State of Salzburg, Austria, 5020
        • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228360
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1090
        • Medizinische Universitaet Wien /ID# 252095
      • Vienna, State of Vienna, Austria, 1160
        • Klinik Ottakring /ID# 243941
  • Belgium
      • Anderlecht, Belgium, 1070
        • Institut Jules Bordet /ID# 225954
      • Bruges, 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
    • Brussels Capital
      • Brussels, Brussels Capital, 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
      • Ghent, 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
    • Paraná
      • Curitiba, Paraná, Brazil, 80060-900
        • Hospital de Clinicas da Universidade Federal do Parana /ID# 226027
    • Puerto Rico
      • Curitiba, Puerto Rico, Brazil, 81520-060
        • Hospital Erasto Gaertner /ID# 262593
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20231-050
        • Instituto Nacional de Cancer (INCA) /ID# 226026
    • São Paulo
      • Jaú, São Paulo, Brazil, 17210-070
        • Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 226065
      • São Paulo, São Paulo, Brazil, 01323-001
        • Real e Benemérita Associação Portuguesa de Beneficência /ID# 226023
      • São Paulo, São Paulo, Brazil, 01323-020
        • Hospital Alemao Oswaldo Cruz /ID# 252833
      • São Paulo, São Paulo, Brazil, 01401-002
        • Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 262394
      • São Paulo, São Paulo, Brazil, 01509-900
        • Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 226809
      • São Paulo, São Paulo, Brazil, 05403-000
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 226048
      • São Paulo, São Paulo, Brazil, 05652-900
        • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 252832
  • Bulgaria
    • Plovdiv
      • Plovdiv, Plovdiv, Bulgaria, 4002
        • UMHAT Sveti Georgi /ID# 245780
    • Sofia
      • Sofia, Sofia, Bulgaria, 1407
        • Acibadem City Clinic Tokuda University Hospital EAD /ID# 244616
      • Sofia, Sofia, Bulgaria, 1431
        • UMHAT Sveti Ivan Rilski /ID# 244615
      • Sofia, 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 - Brampton Civic Hospital /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 Municipality
      • Beijing, Beijing Municipality, China, 100071
        • The Fifth Medical Center of PLA General Hospital /ID# 230941
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer Hospital /ID# 229819
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital /ID# 230975
    • 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 Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Cancer Hospital /ID# 251516
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Provincial Cancer Hospital /ID# 250745
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Tianjin Cancer Hospital /ID# 230974
      • Tianjin, Tianjin Municipality, 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
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Clinical Hospital Dubrava /ID# 251809
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinicka bolnica Merkur /ID# 252481
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Zagreb /ID# 250709
    • Primorje-Gorski Kotar County
      • Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
        • Klinicki bolnicki centar Rijeka /ID# 251811
    • Split-Dalmatia County
      • Split, Split-Dalmatia County, Croatia, 21000
        • Klinicki Bolnicki Centar (KBC) Split /ID# 250729
  • Czechia
      • Prague, Czechia, 150 00
        • Duplicate_Fakultni Nemocnice v Motole /ID# 225958
      • Prague, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady /ID# 225956
      • Prague, 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
    • Capital Region
      • Copenhagen Ø, Capital Region, Denmark, 2100
        • Rigshospitalet /ID# 226576
    • Central Jutland
      • Aarhus, Central Jutland, Denmark, 8200
        • Aarhus Universitetshospital - Skejby /ID# 226594
    • Region Sjælland
      • Roskilde, Region Sjælland, Denmark, 4000
        • Roskilde Sygehus /ID# 226597
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5000
        • Odense University Hospital /ID# 226593
      • Vejle, Region 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
      • Saint-Cloud, France, 92210
        • Institut Curie - site CLCC René Huguenin /ID# 253519
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Chu de Nice-Hopital L'Archet Ii /Id# 226127
    • Auvergne-Rhône-Alpes
      • Clermont, Auvergne-Rhône-Alpes, France, 63100
        • CHU Clermont-Ferrand /ID# 229283
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13009
        • Institut Paoli-Calmettes /ID# 226557
    • Brittany Region
      • Rennes, Brittany Region, France, 35000
        • CHU de Rennes - PONTCHAILLOU /ID# 228207
    • Cote-d Or
      • Dijon, Cote-d Or, France, 21000
        • CHU Dijon /ID# 238345
    • Franche-Comte
      • Limoges, Franche-Comte, France, 87042
        • CHU Limoges - Dupuytren 1 /ID# 234235
    • Herault
      • Montpellier, Herault, France, 34295
        • CHU Montpellier - Hopital Saint Eloi /ID# 228191
    • Isere
      • La Tronche, Isere, France, 38700
        • CHU Grenoble - Hopital Michallon /ID# 226128
    • Meurthe-et-Moselle
      • Vandœuvre-lès-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
      • Créteil, Paris, France, 94010
        • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 226560
      • Paris, Paris, France, 75010
        • Hôpital Saint-Louis /ID# 226126
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, 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-Bénite, Rhone, France, 69495
        • HCL - Hopital Lyon Sud /ID# 227086
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76038
        • Centre Henri Becquerel /ID# 226103
    • Somme
      • Amiens, 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
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75013
        • Hopital Pitie Salpetriere /ID# 238343
  • Greece
      • Athens, Greece, 10676
        • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 225416
    • Attica
      • Athens, Attica, Greece, 11527
        • General Hospital of Athens Laiko /ID# 225399
      • Athens, Attica, Greece, 11528
        • Alexandra General Hospital /ID# 225402
      • Athens, Attica, Greece, 12462
        • University General Hospital Attikon /ID# 225401
    • Ioannina
      • Ioannina, Ioannina, Greece, 45500
        • University General Hospital of Ioannina /ID# 225400
    • Thessaloniki
      • Thessaloniki, Thessaloniki, Greece, 54636
        • General University Hospital of Thessaloniki AXEPA /ID# 225398
      • Thessaloniki, Thessaloniki, Greece, 54639
        • Theageneio Anticancer Hospital /ID# 225516
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet /ID# 227294
    • Budapest
      • Budapest, Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 227239
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary, 9024
        • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 257189
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem-Klinikai Kozpont /ID# 226821
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245938
    • Szeged
      • Szeged, Szeged, Hungary, 6720
        • Szegedi Tudományegyetem /ID# 226838
    • Tolna County
      • Szekszárd, Tolna County, Hungary, 7100
        • Tolna Varmegyei Balassa Janos Korhaz /ID# 250063
    • Vas County
      • Szombathely, Vas County, Hungary, 9700
        • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 226846
  • Israel
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center /ID# 225862
    • Central District
      • Kfar Saba, Central District, Israel, 4428164
        • Meir Medical Center /ID# 225612
      • Tel Aviv, Central District, Israel, 6971028
        • Assuta Tel Aviv Medical Center /ID# 226066
    • H_efa
      • Haifa, H_efa, Israel, 3109601
        • Rambam Health Care Campus /ID# 225981
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center /ID# 259796
      • Jerusalem, Jerusalem, Israel, 91120
        • Hadassah /ID# 225614
    • 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
  • Italy
      • Novara, Italy, 28100
        • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 225773
    • Alessandria
      • Alessandria, Alessandria, Italy, 15100
        • Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Aless /ID# 225542
    • Bari
      • Bari, Bari, Italy, 70124
        • I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 225548
    • Brescia
      • Brescia, Brescia, Italy, 25123
        • Duplicate_ASST Spedali civili di Brescia /ID# 225549
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Duplicate_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
    • Palermo
      • Palermo, Palermo, Italy, 90146
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 225541
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 225775
    • Pisa
      • Pisa, Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana /ID# 225575
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Duplicate_Centro di Riferimento Oncologico /ID# 225553
    • Ravenna
      • Ravenna, Ravenna, Italy, 48121
        • Ospedale Santa Maria Delle Croci /ID# 225571
    • 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-ken
      • Nagoya, Aichi-ken, Japan, 460-0001
        • NHO Nagoya Medical Center /ID# 230677
      • Nagoya, Aichi-ken, 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, Ehime, Japan, 790-8524
        • Matsuyama Red Cross Hospital /ID# 251068
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center /ID# 251622
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital /ID# 226091
    • Fukushima
      • Fukushima, Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital /ID# 250869
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Duplicate_Hokkaido University Hospital /ID# 250149
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Kobe City Medical Center General Hospital /ID# 250597
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital /ID# 251282
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital /ID# 251770
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-8520
        • Kagoshima University Hospital /ID# 250163
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Tokai University Hospital /ID# 251281
    • Miyagi
      • Sendai, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 250150
    • Okayama-ken
      • Okayama, Okayama-ken, 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
        • Duplicate_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, Yamagata, Japan, 990-9585
        • Yamagata University Hospital /ID# 230003
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5223 GZ
        • Jeroen Bosch Ziekenhuis /ID# 229765
      • Deventer, Netherlands, 7416 SE
        • Deventer Ziekenhuis /ID# 229937
      • The Hague, Netherlands, 2512 VA
        • Haaglanden Medisch Centrum /ID# 229686
    • Flevoland
      • Almere Stad, Flevoland, Netherlands, 1315 RA
        • Flevo Ziekenhuis /ID# 229606
    • 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
    • North Brabant
      • Breda, North Brabant, Netherlands, 4818 CK
        • Amphia Ziekenhuis /ID# 229550
      • Eindhoven, North Brabant, Netherlands, 5623 EJ
        • Catharina Ziekenhuis /ID# 230465
      • Eindhoven, North Brabant, Netherlands, 5631 BM
        • Maxima Medisch Centrum /ID# 225603
      • Tilburg, North Brabant, Netherlands, 5022 GC
        • Elisabeth Tweesteden Ziekenhuis /ID# 229773
    • North Holland
      • Alkmaar, North Holland, Netherlands, 1815 JD
        • Noordwest Ziekenhuisgroep /ID# 230613
      • Amsterdam, North Holland, Netherlands, 1081 HV
        • Vrije Universiteit Medisch Centrum /ID# 225608
      • Amsterdam, North Holland, Netherlands, 1091 AC
        • Olvg /Id# 229761
      • Haarlem, North Holland, Netherlands, 2035 RC
        • Spaarne Gasthuis, Haarlem Zuid /ID# 229621
      • Hilversum, North Holland, Netherlands, 1213 XZ
        • Tergooi /ID# 229772
      • Hoorn, North Holland, Netherlands, 1624 NP
        • Dijklander Ziekenhuis /ID# 229900
      • Zaandam, North Holland, Netherlands, 1502 DV
        • Zaans Medisch Centrum /ID# 230614
    • Overijssel
      • Enschede, Overijssel, Netherlands, 7512 KZ
        • Medisch Spectrum Twente /ID# 225610
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden /ID# 225605
    • Provincie Groningen
      • Groningen, Provincie Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen /ID# 225602
    • South Holland
      • Dordrecht, South Holland, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis /ID# 229560
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Leids Universitair Medisch Centrum /ID# 225606
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3813 TZ
        • Meander Medisch Centrum /ID# 229608
      • Nieuwegein, Utrecht, Netherlands, 3435 CM
        • St. Antonius Ziekenhuis /ID# 229901
      • Utrecht, Utrecht, Netherlands, 3582 KE
        • Diakonessenhuis /ID# 251793
  • New Zealand
    • Auckland
      • Takapuna, Auckland, New Zealand, 0622
        • North Shore Hospital /ID# 250992
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • Christchurch Hospital /ID# 250993
  • Poland
    • Greater Poland Voivodeship
      • Piła, Greater Poland Voivodeship, Poland, 64-920
        • ARS-MEDICAL Sp. z o.o. /ID# 225848
      • Skórzewo, Greater Poland Voivodeship, Poland, 60-185
        • Aidport Sp. z o.o. /ID# 227236
    • Pomeranian Voivodeship
      • Słupsk, Pomeranian Voivodeship, Poland, 76-200
        • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka /ID# 228723
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-228
        • Szpital Kliniczny MSWiA z Warminsko-Mazurskim Centrum Onkologii /ID# 225985
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 225986
  • Portugal
    • Braga District
      • Braga, Braga District, Portugal, 4710-243
        • 2CA-Braga, Hospital de Braga /ID# 249112
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1099-023
        • IPO Lisboa FG, EPE /ID# 249109
      • Lisbon, Lisbon District, Portugal, 1649-035
        • Unidade Local de Saude de Santa Maria, EPE /ID# 249111
    • Porto District
      • Porto, Porto District, Portugal, 4200-072
        • IPO Porto FG, EPE /ID# 249110
  • Puerto Rico
    • Puerto Rico
      • Manati, Puerto Rico, Puerto Rico, 00674
        • Hematology and Oncology Institute /ID# 230054
      • Rio Piedras, Puerto Rico, Puerto Rico, 00935
        • Pan American Center for Oncology Trials, LLC /ID# 230052
  • Slovakia
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 833 10
        • Narodny onkologicky ustav /ID# 238847
    • Žilina Region
      • Martin, Žilina Region, 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
      • Kuils River, Western Cape, South Africa, 7580
        • Haemalife Inc. /ID# 243391
  • South Korea
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, South Korea, 47392
        • Inje University - Busan Paik Hospital /ID# 232262
      • Busan, Busan Gwang Yeogsi, South Korea, 49201
        • Dong-A University Medical Center /ID# 228451
    • Gyeonggido
      • Seongnam-si, Gyeonggido, South Korea, 13620
        • Seoul National University Bundang Hospital /ID# 225763
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, South Korea, 42601
        • Keimyung University Dongsan Hospital /ID# 232264
    • Jeonrabugdo
      • Jeonju, Jeonrabugdo, South Korea, 54907
        • Jeonbuk National University Hospital /ID# 232263
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital /ID# 225760
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center /ID# 225758
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Samsung Medical Center /ID# 225759
      • Seoul, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 225761
    • Ulsan Gwang Yeogsi
      • Ulsan, Ulsan Gwang Yeogsi, South Korea, 44033
        • Ulsan University Hospital /ID# 226971
  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Instituto Catalan de Oncologia (ICO) Badalona /ID# 228063
      • Barcelona, Barcelona, Spain, 08003
        • Hospital Parc de Salut del Mar /ID# 225810
      • Barcelona, Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron /ID# 225811
      • Barcelona, Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 226651
      • Barcelona, Barcelona, Spain, 08041
        • Hospital Santa Creu i Sant Pau /ID# 225813
      • 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
    • Madrid
      • Madrid, Madrid, Spain, 28027
        • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 228228
      • Madrid, Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor /ID# 225816
      • Madrid, Madrid, Spain, 28033
        • MD Anderson Madrid /ID# 225817
      • Madrid, Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal /ID# 241750
      • Madrid, Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz /ID# 225804
      • Madrid, Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre /ID# 225815
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de la Arrixaca /ID# 255381
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra - Pamplona /ID# 225809
    • Valencia
      • Valencia, Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia /ID# 225818
  • Sweden
    • Skåne County
      • Lund, Skåne County, Sweden, 224 84
        • Skane University Hospital Lund /ID# 227285
    • Stockholm County
      • Solna, Stockholm County, Sweden, 171 64
        • Karolinska University Hospital Solna /ID# 229284
    • Västra Götaland County
      • Borås, Västra Götaland County, Sweden, 501 82
        • Sodra Alvsborgs sjukhus /ID# 228885
      • Gothenburg, Västra Götaland County, Sweden, 413 46
        • Sahlgrenska Universitetssjukhuset /ID# 250089
    • Östergötland County
      • Linköping, Östergötland County, Sweden, 581 85
        • Linkoping University Hospital /ID# 233521
  • Switzerland
    • Canton of Aargau
      • Aarau, Canton of Aargau, Switzerland, 5001
        • Kantonsspital Aarau AG /ID# 229112
    • Canton of Bern
      • Thun, Canton of Bern, Switzerland, 3600
        • Spital Thun /ID# 229499
    • Canton of Zurich
      • Winterthur, Canton of Zurich, Switzerland, 8400
        • KSW Kantonsspital Winterthur /ID# 241631
  • Taiwan
    • Kaohsiung
      • Kaohsiung City, Kaohsiung, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital /ID# 226670
    • Taichung
      • Taichung, Taichung, Taiwan, 40447
        • China Medical University Hospital /ID# 226188
      • Taichung, Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital /ID# 226674
    • Tainan
      • Tainan, Tainan, Taiwan, 704
        • National Cheng Kung University Hospital /ID# 226671
  • Turkey (Türkiye)
      • Malatya, Turkey (Türkiye), 44280
        • Inonu University Medical Faculty /ID# 226572
      • Yüreğir, Turkey (Türkiye), 01240
        • Baskent Universitesi Adana Uyg. ve Arast. Merkezi Yuregir Baskent Hastanesi /ID# 225921
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06620
        • Ankara Universitesi Fakultesi /ID# 227331
    • Kocaeli
      • Dilovası, Kocaeli, Turkey (Türkiye), 41455
        • Anadolu Saglik Merkezi /ID# 225777
    • Samsun
      • Samsun, Samsun, Turkey (Türkiye), 55139
        • Ondokuz Mayis Universitesi /ID# 251247
    • Trabzon
      • Trabzon, Trabzon, Turkey (Türkiye), 61000
        • Karadeniz University /ID# 226573
  • United Kingdom
      • Edinburgh, United Kingdom, EH3 9HE
        • NHS Lothian /ID# 229055
    • Birmingham
      • Birmingham, Birmingham, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust /ID# 229197
    • 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
        • Duplicate_University of Arizona Cancer Center - North Campus /ID# 227463
      • Yuma, Arizona, United States, 85364
        • Yuma Regional Medical Center Cancer 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
        • Duplicate_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
      • 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
      • The Bronx, New York, United States, 10469
        • New York Cancer and Blood Specialists- Eastchester, Bronx /ID# 265396
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Up to Approximately 46 Months
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
Time Frame: Up to Approximately 46 Months
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)
Time Frame: Up to Approximately 46 Months
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)
Time Frame: Up to Approximately 76 Months
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
Time Frame: Up to Approximately 46 Months
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)
Time Frame: On or After to Approximately 28 Weeks
CR on or after EOT, determined by Lugano 2014 criteria as assessed by IRC.
On or After to Approximately 28 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genmab

Collaborators

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20-621
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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