A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (EPCORE DLBCL-4)

April 2, 2026 updated by: Genmab

A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective epcoritamab plus lenalidomide (E-Len) is compared to rituximab plus gemcitabine and oxaliplatin (R-GemOx) )in treating adult participants with relapsed or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). Adverse events and change in disease condition will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 360 adult participants with R/R DLBCL will be enrolled in approximately 165 sites across the world.

Participants in arm A will receive subcutaneous (SC) injections of epcoritamab plus oral lenalidomide capsules (E-Len) for up to 12 cycles (each cycle is 28 days). Participants in arm B will receive intravenously (IV) infused R-GemOx for up to 4 cycles (each cycle is 28 days). Participants in arm C will receive SC injections of epcoritamab for up to 12 cycles (each cycle is 28 days).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
379

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, 1629
        • Hospital Universitario Austral /ID# 242791
    • Buenos Aires F.D.
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1114
        • Fundaleu /Id# 242789
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1426
        • Instituto Alexander Fleming /ID# 263804
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Canberra Hospital /ID# 265312
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital /ID# 263242
      • Wollongong, New South Wales, Australia, 2500
        • Wollongong Hospital /ID# 244646
    • Queensland
      • Toowoomba, Queensland, Australia, 4350
        • Toowoomba Hospital /ID# 263243
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health - Monash Medical Centre /ID# 262783
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital /ID# 243790
  • Belgium
    • Brussels Capital
      • Jette, Brussels Capital, Belgium, 1090
        • Universitair Ziekenhuis Brussel /ID# 242574
    • Hainaut
      • Boussu, Hainaut, Belgium, 7301
        • Centre Hospitalier Epicura - Hornu /ID# 265148
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 242565
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 246671
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • AZ-Delta. /ID# 264740
  • Brazil
      • São Paulo, Brazil, 01323-020
        • Hospital Alemao Oswaldo Cruz /ID# 247418
      • São Paulo, Brazil, 01401-002
        • Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 263944
      • São Paulo, Brazil, 05403-000
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 242425
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41253-190
        • Hospital Sao Rafael /ID# 262949
    • Puerto Rico
      • Curitiba, Puerto Rico, Brazil, 81520-060
        • Hospital Erasto Gaertner /ID# 264049
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 264045
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • UMHAT Sveti Georgi /ID# 242905
      • Sofia, Bulgaria, 1431
        • UMHAT Sveti Ivan Rilski /ID# 242389
      • Sofia, Bulgaria, 1797
        • SHAT Hematologic Diseases /ID# 242708
      • Varna, Bulgaria, 9009
        • UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 262761
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 262751
  • Chile
      • Santiago, Chile, 7650568
        • Clinica Alemana de Santiago /ID# 244139
    • Santiago Metropolitan
      • Providencia, Santiago Metropolitan, Chile, 7500921
        • Fundacion Arturo Lopez Perez /ID# 242421
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Bradford Hill /ID# 262795
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital /ID# 242941
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Province Cancer Hospital /ID# 265075
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen /ID# 264305
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center /ID# 242712
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial Peoples Hospital /ID# 242942
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The Second Hospital of Hebei Medical University /ID# 242944
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital /Id# 242961
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital /ID# 242700
    • Hubei
      • Wuhan, Hubei, China, 430048
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 242702
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital /ID# 242963
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Peoples Hospital /ID# 271924
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University /ID# 242939
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University /ID# 242703
      • Nanchang, Jiangxi, China, 330029
        • Jiangxi Provincial Cancer Hospital /ID# 242968
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University /ID# 242940
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • First Affiliated Hospital of China Medical University /ID# 242701
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital /ID# 264036
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200065
        • Shanghai Tongji Hospital /ID# 263952
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Tianjin Cancer Hospital /ID# 243940
      • Tianjin, Tianjin Municipality, China, 300020
        • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 243139
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 242966
    • Yunnan
      • Kunming, Yunnan, China, 650106
        • Yunnan Province Cancer Hospital /ID# 264057
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 242960
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer hospital /ID# 242711
      • Hangzhou, Zhejiang, China, 310052
        • Second Affiliated Hospital, Zhejiang University - Binjiang Campus /ID# 243137
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University /ID# 263951
  • Croatia
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinicka bolnica Merkur /ID# 262619
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Sestre milosrdnice /ID# 262620
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Zagreb /ID# 262617
    • County of Osijek-Baranja
      • Osijek, County of Osijek-Baranja, Croatia, 31000
        • Klinicki bolnicki centar Osijek /ID# 262621
    • Primorje-Gorski Kotar County
      • Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
        • Klinički Bolnički Centar Rijeka /ID# 266004
    • Split-Dalmatia County
      • Split, Split-Dalmatia County, Croatia, 21000
        • Klinicki Bolnicki Centar (KBC) Split /ID# 262618
  • Czechia
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc /ID# 262832
    • Hradec Kralove
      • Hradec Králové, Hradec Kralove, Czechia, 500 05
        • Fakultní nemocnice Hradec Králové - Sokolská /ID# 264071
    • Praha 5
      • Prague, Praha 5, Czechia, 150 06
        • Fakultni nemocnice Motol a Homolka /ID# 272378
  • France
      • Lille, France, 59020
        • Hopital Saint Vincent de Paul /ID# 243070
    • Alsace
      • Strasbourg, Alsace, France, 67200
        • Les Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre /ID# 264068
    • Calvados
      • Caen, Calvados, France, 14033
        • CHU de CAEN - Hopital de la Cote de Nacre /ID# 243075
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37044
        • CHRU Tours - Hopital Bretonneau /ID# 244580
    • Provence-Alpes-Côte d'Azur Region
      • Avignon, Provence-Alpes-Côte d'Azur Region, France, 84000
        • Centre Hospitalier D'Avignon /ID# 243072
    • Pyrenees-Atlantiques
      • Bayonne, Pyrenees-Atlantiques, France, 64100
        • Centre Hospitalier de la Cote Basque /ID# 243065
    • Vienne
      • Poitiers, Vienne, France, 86000
        • CHU Poitiers - La miletrie /ID# 243074
  • Greece
      • Athens, Greece, 10676
        • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 242039
      • Thessaloniki, Greece, 54636
        • General University Hospital of Thessaloniki AXEPA /ID# 242038
      • Thessaloniki, Greece, 54639
        • Theageneio Anticancer Hospital /ID# 242036
    • Attica
      • Athens, Attica, Greece, 11527
        • General Hospital of Athens Laiko /ID# 262809
      • Athens, Attica, Greece, 12462
        • University General Hospital Attikon /ID# 242041
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 242455
      • Budapest, Hungary, 1097
        • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 262923
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet /ID# 242457
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 262924
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary, 9024
        • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 262901
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem-Klinikai Kozpont /ID# 242451
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 242468
  • Japan
    • Aichi-ken
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Fujita Health University Hospital /ID# 265968
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center /ID# 265977
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital /ID# 267624
    • Fukushima
      • Fukushima, Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital /ID# 264667
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital /ID# 264928
    • Hyōgo
      • Amagasaki, Hyōgo, Japan, 660-8550
        • Hyogo Prefectural Amagasaki General Medical Center /ID# 277258
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-8520
        • Kagoshima University Hospital /ID# 248259
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Tokai University Hospital /ID# 265433
      • Kamakura, Kanagawa, Japan, 247-8533
        • Shonankamakura General Hospital /ID# 277671
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital /ID# 266018
      • Sakai-shi, Osaka, Japan, 590-0197
        • Kindai University Hospital /ID# 265474
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Duplicate_Saitama Cancer Center /ID# 265277
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 409-3898
        • University of Yamanashi Hospital /ID# 264671
  • Mexico
      • Jalisco, Mexico, 45645
        • Centro de Quimioterapia E Investigacion Sas de Cv /Id# 263293
    • Mexico City
      • Mexico City, Mexico City, Mexico, 04100
        • Centro De Investigación Clinica Chapultepec /ID# 243959
  • Netherlands
    • North Brabant
      • 's-Hertogenbosch, North Brabant, Netherlands, 5223 GZ
        • Jeroen Bosch Ziekenhuis, locatie 's-Hertogenbosch /ID# 265204
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1091 AC
        • OLVG - Locatie Oost /ID# 263355
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden /ID# 245501
    • South Holland
      • Dordrecht, South Holland, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 263361
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435 CM
        • St. Antonius Ziekenhuis /ID# 245197
  • New Zealand
      • Auckland, New Zealand, 0622
        • North Shore Hospital /ID# 266060
      • Wellington, New Zealand, 6021
        • Wellington Hospital /ID# 265966
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-175
        • Aidport sp z o.o. /ID# 262766
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Pratia MCM Krakow /ID# 262882
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 263314
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 242436
  • Portugal
      • Porto, Portugal, 4200-072
        • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 262961
      • Porto, Portugal, 4200-319
        • Unidade Local de Saude Sao Joao, EPE /ID# 262962
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1500-650
        • Hospital da Luz /ID# 262965
  • Romania
      • Bucharest, Romania, 030171
        • Spitalul Clinic Coltea /ID# 243694
    • București
      • Bucharest, București, Romania, 022328
        • Fundeni Clinical Institute /ID# 266734
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca /ID# 243753
    • Iaşi
      • Iași, Iaşi, Romania, 700483
        • Institutul Regional de Oncologie /ID# 244367
  • Serbia
      • Novi Sad, Serbia, 21000
        • University Clinical Center Vojvodina /ID# 264138
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Clinical Hospital Center Zvezdara /ID# 263059
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Oncology and Radiology of Serbia /ID# 263055
      • Belgrade, Beograd, Serbia, 11000
        • University Clinical Center Serbia /ID# 263057
      • Belgrade, Beograd, Serbia, 11080
        • Clinical Hospital Center - Bežanijska Kosa /ID# 263053
    • Nisavski Okrug
      • Niš, Nisavski Okrug, Serbia, 18300
        • University Clinical Center Nis /ID# 263701
    • Vojvodina
      • Kamenitz, Vojvodina, Serbia, 21208
        • Institute for Oncology of Vojvodina /ID# 263052
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital /ID# 264016
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 169611
        • National Cancer Centre Singapore /ID# 267015
      • Singapore, Central Singapore, Singapore, 308433
        • Tan Tock Seng Hospital /ID# 266061
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1864
        • Wits Clinical Research /ID# 264656
      • Pretoria, Gauteng, South Africa, 0044
        • Alberts Cellular Therapy /ID# 262720
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7800
        • Constantiaberg Haematology /ID# 273041
      • Kuils River, Western Cape, South Africa, 7580
        • Haemalife Inc. /ID# 262719
  • South Korea
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, South Korea, 47392
        • Inje University - Busan Paik Hospital /ID# 262842
      • Busan, Busan Gwang Yeogsi, South Korea, 49201
        • Dong-A University Medical Center /ID# 262841
    • Gyeonggido
      • Seongnam-si, Gyeonggido, South Korea, 13620
        • Seoul National University Bundang Hospital /ID# 242405
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, South Korea, 42601
        • Keimyung University Dongsan Hospital /ID# 262840
    • Jeonrabugdo
      • Jeonju, Jeonrabugdo, South Korea, 54907
        • Jeonbuk National University Hospital /ID# 242958
    • Jeonranamdo
      • Hwasun-gun, Jeonranamdo, South Korea, 58128
        • Chonnam National University Hwasun Hospital /ID# 262843
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital /ID# 242407
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center /ID# 242409
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Samsung Medical Center /ID# 242408
      • Seoul, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242406
    • Ulsan Gwang Yeogsi
      • Ulsan, Ulsan Gwang Yeogsi, South Korea, 44033
        • Ulsan University Hospital /ID# 242956
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital /ID# 242931
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital /ID# 242937
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital /ID# 243301
    • Taipei
      • Taipei City, Taipei, Taiwan, 100
        • National Taiwan University Hospital /ID# 243300
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06620
        • Ankara Universitesi Fakultesi /ID# 242410
      • Aydin, Turkey (Türkiye), 09100
        • Adnan Menderes University /ID# 242418
      • Edirne, Istanbul, Turkey (Türkiye), 22030
        • Trakya University Medical Facu /ID# 242419
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 242414
      • Istanbul, Turkey (Türkiye), 34365
        • Vehbi Koc vakfi Amerikan Hasta /ID# 242415
      • Izmir, Turkey (Türkiye), 35040
        • Ege University Medical Faculty /ID# 242417
      • Samsun, Turkey (Türkiye), 55200
        • Ondokuz mayis University Facul /ID# 242412
      • Trabzon, Turkey (Türkiye), 61080
        • Karadeniz Technical University Farabi Hospital /ID# 264694
      • Şişli, Turkey (Türkiye), 34381
        • Istanbul Florence Nightingale Hospital /ID# 271544
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE3 3HD
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 242923
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital /ID# 265130
    • North Lanarkshire
      • Airdrie, North Lanarkshire, United Kingdom, ML6 0JS
        • NHS Lanarkshire /ID# 272332
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham City Hospital /ID# 265129
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center /ID# 273338
      • Los Angeles, California, United States, 90067
        • Valkyrie Clinical Trials /ID# 269935
      • Palm Springs, California, United States, 92262
        • Desert Regional Medical Center /ID# 272437
    • Colorado
      • Golden, Colorado, United States, 80401
        • Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823
    • Georgia
      • Newnan, Georgia, United States, 30265
        • City Of Hope - Atlanta. /ID# 273092
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center /ID# 242103
      • Zion, Illinois, United States, 60099
        • City Of Hope - Chicago /ID# 274430
    • Indiana
      • Dyer, Indiana, United States, 46311
        • Northwest Cancer Center - Dyer Clinic /ID# 269787
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas - Wichita /ID# 270117
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center. /ID# 242087
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore /ID# 242216
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital /ID# 266446
    • Mississippi
      • Gulfport, Mississippi, United States, 39501
        • Gulfport Memorial Hospital /ID# 268104
    • New York
      • Valhalla, New York, United States, 10595
        • New York Medical College /ID# 265799
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • East Carolina University - Brody School of Medicine /ID# 242227
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Ctr /ID# 242149
    • Utah
      • Ogden, Utah, United States, 84405
        • Community Cancer Trials Of Utah /ID# 271715
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists - Salt Lake City /ID# 268603
      • Salt Lake City, Utah, United States, 84108
        • Veterans Affairs Medical Center - Salt Lake City /ID# 265329

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eastern Cooperative Oncology Group Performance status score of 0 to 2.
  • Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented in the most recent and representative pathology report, inclusive of the following according to the World Health Organization (WHO) 2022 as per the protocol.
  • Must have relapsed or refractory (R/R) disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis.

  • Participant must meet at least 1 of the following criteria:

    • Failed prior autologous stem cell transplant (ASCT), defined as relapsed after ASCT or been refractory to high-dose therapy (HDT)-ASCT.
    • Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT.

    • Be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) meeting at least 1 of the following criteria:

      • Unable to receive CAR-T therapy due to fitness and/or comorbidity.
      • Lymphocyte apheresis failure.
      • Unwilling to receive CAR-T therapy.
      • Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints.
      • Relapsed/progressed after having achieved at least a Partial Response (PR) or Complete Response (CR) while on prior CAR-T therapy.
  • Must have measurable disease.
  • Life expectancy > 3 months on standard of care treatment at the time of enrolling in the study

Exclusion Criteria:

  • Current evidence of primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening.
  • History of prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with rituximab plus gemcitabine and oxaliplatin (R-GemOx) or gemcitabine and oxaliplatin (GemOx).
  • Documented refractoriness to lenalidomide.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: Epcoritamab Plus Lenalidomide (E-Len)
Participants will receive E-Len for up to 12 cycles (each cycle is 28 days).
Drug: Epcoritamab
Subcutaneous Injection
Other Names:
  • ABBV-GMAB-3013
  • Epkinly
Drug: Lenalidomide
Oral Capsule
Experimental: Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx)
Participants will receive R-GemOx for up to 4 cycles (each cycle is 28 days)
Drug: Rituximab
Intravenous (IV) Infusion
Drug: Oxaliplatin
IV Infusion
Drug: Gemcitabine
IV Infusion
Experimental: Arm C: Epcoritamab
Participants will receive epcoritamab for up to 12 cycles (each cycle is 28 days).
Drug: Epcoritamab
Subcutaneous Injection
Other Names:
  • ABBV-GMAB-3013
  • Epkinly

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Arm A vs Arm B: Progression-Free Survival (PFS)
Time Frame: Up to 4 Years
PFS is defined as the duration from the date of randomization to the date of disease progression determined per Lugano 2014 criteria as assessed by an independent review committee (IRC), or death, whichever occurs first.
Up to 4 Years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Arm A vs Arm B: Percentage of Participants Who Achieve Complete response (CR)
Time Frame: Up to 4 Years
CR is defined as the percentage of participants who achieve CR determined by Lugano 2014 criteria, as assessed by an IRC that is blinded to treatment arm prior to the initiation of new anti-lymphoma therapy.
Up to 4 Years
Arm A vs Arm B: Overall Survival (OS)
Time Frame: Up to 4 Years
OS is defined as the time from randomization to death from any cause.
Up to 4 Years
Arm A vs Arm B: Percentage of Participants Who Achieve Minimal Residual Disease (MRD) Negativity Rate
Time Frame: Up to 4 Years
The MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of new anti-lymphoma therapy.
Up to 4 Years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genmab

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M22-128
  • 2024-510965-41 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Genmab is committed to responsible data sharing regarding the clinical trials we sponsor. 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

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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