AzTrials
AzTrials

Diffuse Large B-Cell LymphomaPhase 3EPCORE DLBCL-4NCT06508658

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

A Phase 3 study testing Epcoritamab, Rituximab and Lenalidomide in people with Diffuse Large B-Cell Lymphoma, run by Genmab at 176 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
Epcoritamab, Rituximab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
379 participants
Where
176 sitesin 28 countries
Study dates
13 Aug 2024to Mar 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.

Trial locations and contacts

176 sites in 28 countries.

176 sites in 28 countries

China26 sites

  • Peking University Third Hospital /ID# 242941

    Beijing, Beijing Municipality, 100191

  • The First Hospital of Jilin University /ID# 242940

    Changchun, Jilin, 130021

  • Fujian Province Cancer Hospital /ID# 265075

    Fuzhou, Fujian, 350014

  • Sun Yat-Sen University Cancer Center /ID# 242712

    Guangzhou, Guangdong, 510060

  • Guangdong Provincial Peoples Hospital /ID# 242942

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 242960

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer hospital /ID# 242711

    Hangzhou, Zhejiang, 310022

  • Second Affiliated Hospital, Zhejiang University - Binjiang Campus /ID# 243137

    Hangzhou, Zhejiang, 310052

  • Harbin Medical University Cancer Hospital /Id# 242961

    Harbin, Heilongjiang, 150081

  • Shandong Cancer Hospital /ID# 264036

    Jinan, Shandong, 250117

  • Yunnan Province Cancer Hospital /ID# 264057

    Kunming, Yunnan, 650106

  • The First Affiliated Hospital of Nanchang University /ID# 242703

    Nanchang, Jiangxi, 330006

  • Jiangxi Provincial Cancer Hospital /ID# 242968

    Nanchang, Jiangxi, 330029

  • Jiangsu Peoples Hospital /ID# 271924

    Nanjing, Jiangsu, 210029

  • Shanghai Tongji Hospital /ID# 263952

    Shanghai, Shanghai Municipality, 200065

  • First Affiliated Hospital of China Medical University /ID# 242701

    Shenyang, Liaoning, 110001

  • The Second Hospital of Hebei Medical University /ID# 242944

    Shijiazhuang, Hebei, 050000

  • The First Affiliated Hospital of Soochow University /ID# 242939

    Suzhou, Jiangsu, 215006

  • Tianjin Cancer Hospital /ID# 243940

    Tianjin, Tianjin Municipality, 300000

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 243139

    Tianjin, Tianjin Municipality, 300020

  • The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 242966

    Ürümqi, Xinjiang, 830000

  • The First Affiliated Hospital of Wenzhou Medical University /ID# 263951

    Wenzhou, Zhejiang, 325000

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 242702

    Wuhan, Hubei, 430048

  • Hubei Cancer Hospital /ID# 242963

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xiamen /ID# 264305

    Xiamen, Fujian, 361003

  • Henan Cancer Hospital /ID# 242700

    Zhengzhou, Henan, 450008

Other trials in China

United States19 sites

  • University of Maryland, Baltimore /ID# 242216

    Baltimore, Maryland, 21201

  • Rush University Medical Center /ID# 242103

    Chicago, Illinois, 60612

  • Henry Ford Hospital /ID# 266446

    Detroit, Michigan, 48202

  • City of Hope National Medical Center /ID# 273338

    Duarte, California, 91010

  • Northwest Cancer Center - Dyer Clinic /ID# 269787

    Dyer, Indiana, 46311

  • Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823

    Golden, Colorado, 80401

  • East Carolina University - Brody School of Medicine /ID# 242227

    Greenville, North Carolina, 27834

  • Gulfport Memorial Hospital /ID# 268104

    Gulfport, Mississippi, 39501

  • Thompson Cancer Survival Ctr /ID# 242149

    Knoxville, Tennessee, 37916

  • University of Kentucky Chandler Medical Center. /ID# 242087

    Lexington, Kentucky, 40536

  • Valkyrie Clinical Trials /ID# 269935

    Los Angeles, California, 90067

  • City Of Hope - Atlanta. /ID# 273092

    Newnan, Georgia, 30265

  • Community Cancer Trials Of Utah /ID# 271715

    Ogden, Utah, 84405

  • Desert Regional Medical Center /ID# 272437

    Palm Springs, California, 92262

  • Utah Cancer Specialists - Salt Lake City /ID# 268603

    Salt Lake City, Utah, 84106

  • Veterans Affairs Medical Center - Salt Lake City /ID# 265329

    Salt Lake City, Utah, 84108

  • New York Medical College /ID# 265799

    Valhalla, New York, 10595

  • Cancer Center of Kansas - Wichita /ID# 270117

    Wichita, Kansas, 67214

  • City Of Hope - Chicago /ID# 274430

    Zion, Illinois, 60099

Other trials in United States

Japan13 sites

  • Hyogo Prefectural Amagasaki General Medical Center /ID# 277258

    Amagasaki, Hyōgo, 660-8550

  • University of Yamanashi Hospital /ID# 264671

    Chuo-shi, Yamanashi, 409-3898

  • Kyushu University Hospital /ID# 267624

    Fukuoka, Fukuoka, 812-8582

  • Fukushima Medical University Hospital /ID# 264667

    Fukushima, Fukushima, 960-1295

  • Kansai Medical University Hospital /ID# 266018

    Hirakata-shi, Osaka, 573-1191

  • Tokai University Hospital /ID# 265433

    Isehara, Kanagawa, 259-1193

  • Kagoshima University Hospital /ID# 248259

    Kagoshima, Kagoshima-ken, 890-8520

  • Shonankamakura General Hospital /ID# 277671

    Kamakura, Kanagawa, 247-8533

  • Duplicate_Saitama Cancer Center /ID# 265277

    Kitaadachi-gun, Saitama, 362-0806

  • National Hospital Organization Shikoku Cancer Center /ID# 265977

    Matsuyama, Ehime, 791-0280

  • Kindai University Hospital /ID# 265474

    Sakai-shi, Osaka, 590-0197

  • Sapporo Medical University Hospital /ID# 264928

    Sapporo, Hokkaido, 060-8543

  • Fujita Health University Hospital /ID# 265968

    Toyoake, Aichi-ken, 470-1192

Other trials in Japan

South Korea11 sites

  • Inje University - Busan Paik Hospital /ID# 262842

    Busan, Busan Gwang Yeogsi, 47392

  • Dong-A University Medical Center /ID# 262841

    Busan, Busan Gwang Yeogsi, 49201

  • Keimyung University Dongsan Hospital /ID# 262840

    Daegu, Gyeongsangbuk-do, 42601

  • Chonnam National University Hwasun Hospital /ID# 262843

    Hwasun-gun, Jeonranamdo, 58128

  • Jeonbuk National University Hospital /ID# 242958

    Jeonju, Jeonrabugdo, 54907

  • Seoul National University Bundang Hospital /ID# 242405

    Seongnam-si, Gyeonggido, 13620

  • Seoul National University Hospital /ID# 242407

    Seoul, Seoul Teugbyeolsi, 03080

  • Asan Medical Center /ID# 242409

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center /ID# 242408

    Seoul, Seoul Teugbyeolsi, 06351

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242406

    Seoul, Seoul Teugbyeolsi, 06591

  • Ulsan University Hospital /ID# 242956

    Ulsan, Ulsan Gwang Yeogsi, 44033

Other trials in South Korea

Turkey (Türkiye)9 sites

  • Ankara Universitesi Fakultesi /ID# 242410

    Ankara, 06620

  • Adnan Menderes University /ID# 242418

    Aydin, 09100

  • Trakya University Medical Facu /ID# 242419

    Edirne, Istanbul, 22030

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 242414

    Istanbul, 34098

  • Vehbi Koc vakfi Amerikan Hasta /ID# 242415

    Istanbul, 34365

  • Ege University Medical Faculty /ID# 242417

    Izmir, 35040

  • Ondokuz mayis University Facul /ID# 242412

    Samsun, 55200

  • Istanbul Florence Nightingale Hospital /ID# 271544

    Şişli, 34381

  • Karadeniz Technical University Farabi Hospital /ID# 264694

    Trabzon, 61080

Other trials in Turkey (Türkiye)

France7 sites

  • Centre Hospitalier D'Avignon /ID# 243072

    Avignon, Provence-Alpes-Côte d'Azur Region, 84000

  • Centre Hospitalier de la Cote Basque /ID# 243065

    Bayonne, Pyrenees-Atlantiques, 64100

  • CHU de CAEN - Hopital de la Cote de Nacre /ID# 243075

    Caen, Calvados, 14033

  • Hopital Saint Vincent de Paul /ID# 243070

    Lille, 59020

  • CHU Poitiers - La miletrie /ID# 243074

    Poitiers, Vienne, 86000

  • Les Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre /ID# 264068

    Strasbourg, Alsace, 67200

  • CHRU Tours - Hopital Bretonneau /ID# 244580

    Tours, Indre-et-Loire, 37044

Other trials in France

Hungary7 sites

  • Semmelweis Egyetem /ID# 242455

    Budapest, 1085

  • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 262923

    Budapest, 1097

  • Orszagos Onkologiai Intezet /ID# 242457

    Budapest, 1122

  • Debreceni Egyetem-Klinikai Kozpont /ID# 242451

    Debrecen, Hajdú-Bihar, 4032

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 262901

    Győr, Győr-Moson-Sopron, 9024

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 242468

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 262924

    Pécs, Baranya, 7624

Other trials in Hungary

Serbia7 sites

  • Clinical Hospital Center Zvezdara /ID# 263059

    Belgrade, Beograd, 11000

  • Institute for Oncology and Radiology of Serbia /ID# 263055

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 263057

    Belgrade, Beograd, 11000

  • Clinical Hospital Center - Bežanijska Kosa /ID# 263053

    Belgrade, Beograd, 11080

  • Institute for Oncology of Vojvodina /ID# 263052

    Kamenitz, Vojvodina, 21208

  • University Clinical Center Nis /ID# 263701

    Niš, Nisavski Okrug, 18300

  • University Clinical Center Vojvodina /ID# 264138

    Novi Sad, 21000

Other trials in Serbia

Australia6 sites

  • Monash Health - Monash Medical Centre /ID# 262783

    Clayton, Victoria, 3168

  • Canberra Hospital /ID# 265312

    Garran, Australian Capital Territory, 2605

  • Royal Perth Hospital /ID# 243790

    Perth, Western Australia, 6000

  • Royal Prince Alfred Hospital /ID# 263242

    Sydney, New South Wales, 2050

  • Toowoomba Hospital /ID# 263243

    Toowoomba, Queensland, 4350

  • Wollongong Hospital /ID# 244646

    Wollongong, New South Wales, 2500

Other trials in Australia

Brazil6 sites

  • Hospital Erasto Gaertner /ID# 264049

    Curitiba, Puerto Rico, 81520-060

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 264045

    Ribeirão Preto, São Paulo, 14049-900

  • Hospital Sao Rafael /ID# 262949

    Salvador, Estado de Bahia, 41253-190

  • Hospital Alemao Oswaldo Cruz /ID# 247418

    São Paulo, 01323-020

  • Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 263944

    São Paulo, 01401-002

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 242425

    São Paulo, 05403-000

Other trials in Brazil

Croatia6 sites

  • Klinicki bolnicki centar Osijek /ID# 262621

    Osijek, County of Osijek-Baranja, 31000

  • Klinički Bolnički Centar Rijeka /ID# 266004

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki Bolnicki Centar (KBC) Split /ID# 262618

    Split, Split-Dalmatia County, 21000

  • Klinicka bolnica Merkur /ID# 262619

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Sestre milosrdnice /ID# 262620

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 262617

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Belgium5 sites

  • Centre Hospitalier Epicura - Hornu /ID# 265148

    Boussu, Hainaut, 7301

  • Universitair Ziekenhuis Brussel /ID# 242574

    Jette, Brussels Capital, 1090

  • Universitair Ziekenhuis Leuven /ID# 246671

    Leuven, Vlaams-Brabant, 3000

  • AZ-Delta. /ID# 264740

    Roeselare, West-Vlaanderen, 8800

  • Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 242565

    Yvoir, Namur, 5530

Other trials in Belgium

Greece5 sites

  • General Hospital of Athens Laiko /ID# 262809

    Athens, Attica, 11527

  • University General Hospital Attikon /ID# 242041

    Athens, Attica, 12462

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 242039

    Athens, 10676

  • General University Hospital of Thessaloniki AXEPA /ID# 242038

    Thessaloniki, 54636

  • Theageneio Anticancer Hospital /ID# 242036

    Thessaloniki, 54639

Other trials in Greece

Netherlands5 sites

  • Jeroen Bosch Ziekenhuis, locatie 's-Hertogenbosch /ID# 265204

    's-Hertogenbosch, North Brabant, 5223 GZ

  • OLVG - Locatie Oost /ID# 263355

    Amsterdam, North Holland, 1091 AC

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 263361

    Dordrecht, South Holland, 3318 AT

  • Medisch Centrum Leeuwarden /ID# 245501

    Leeuwarden, Provincie Friesland, 8934 AD

  • St. Antonius Ziekenhuis /ID# 245197

    Nieuwegein, Utrecht, 3435 CM

Other trials in Netherlands

Bulgaria4 sites

  • UMHAT Sveti Georgi /ID# 242905

    Plovdiv, 4002

  • UMHAT Sveti Ivan Rilski /ID# 242389

    Sofia, 1431

  • SHAT Hematologic Diseases /ID# 242708

    Sofia, 1797

  • UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 262761

    Varna, 9009

Other trials in Bulgaria

Poland4 sites

  • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 242436

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • Pratia MCM Krakow /ID# 262882

    Krakow, Lesser Poland Voivodeship, 30-727

  • Aidport sp z o.o. /ID# 262766

    Poznan, Greater Poland Voivodeship, 60-175

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 263314

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Romania4 sites

  • Fundeni Clinical Institute /ID# 266734

    Bucharest, Bucharest, 022328

  • Spitalul Clinic Coltea /ID# 243694

    Bucharest, 030171

  • Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca /ID# 243753

    Cluj-Napoca, Cluj, 400015

  • Institutul Regional de Oncologie /ID# 244367

    Iași, Iaşi, 700483

Other trials in Romania

South Africa4 sites

  • Constantiaberg Haematology /ID# 273041

    Cape Town, Western Cape, 7800

  • Wits Clinical Research /ID# 264656

    Johannesburg, Gauteng, 1864

  • Haemalife Inc. /ID# 262719

    Kuils River, Western Cape, 7580

  • Alberts Cellular Therapy /ID# 262720

    Pretoria, Gauteng, 0044

Other trials in South Africa

Taiwan4 sites

  • China Medical University Hospital /ID# 242931

    Taichung, 40447

  • Taichung Veterans General Hospital /ID# 242937

    Taichung, 40705

  • National Cheng Kung University Hospital /ID# 243301

    Tainan, 704

  • National Taiwan University Hospital /ID# 243300

    Taipei City, Taipei, 100

Other trials in Taiwan

United Kingdom4 sites

  • NHS Lanarkshire /ID# 272332

    Airdrie, North Lanarkshire, ML6 0JS

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 242923

    Newcastle upon Tyne, NE3 3HD

  • Nottingham City Hospital /ID# 265129

    Nottingham, Nottinghamshire, NG5 1PB

  • Royal Cornwall Hospital /ID# 265130

    Truro, Cornwall, TR1 3LQ

Other trials in United Kingdom

Argentina3 sites

  • Fundaleu /Id# 242789

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1114

  • Instituto Alexander Fleming /ID# 263804

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1426

  • Hospital Universitario Austral /ID# 242791

    Pilar, Buenos Aires, 1629

Other trials in Argentina

Chile3 sites

  • Fundacion Arturo Lopez Perez /ID# 242421

    Providencia, Santiago Metropolitan, 7500921

  • Bradford Hill /ID# 262795

    Santiago, Santiago Metropolitan, 8420383

  • Clinica Alemana de Santiago /ID# 244139

    Santiago, 7650568

Other trials in Chile

Czechia3 sites

  • Fakultní nemocnice Hradec Králové - Sokolská /ID# 264071

    Hradec Králové, Hradec Kralove, 500 05

  • Fakultni nemocnice Olomouc /ID# 262832

    Olomouc, 779 00

  • Fakultni nemocnice Motol a Homolka /ID# 272378

    Prague, Praha 5, 150 06

Other trials in Czechia

Portugal3 sites

  • Hospital da Luz /ID# 262965

    Lisbon, Lisbon District, 1500-650

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 262961

    Porto, 4200-072

  • Unidade Local de Saude Sao Joao, EPE /ID# 262962

    Porto, 4200-319

Other trials in Portugal

Singapore3 sites

  • National Cancer Centre Singapore /ID# 267015

    Singapore, Central Singapore, 169611

  • Tan Tock Seng Hospital /ID# 266061

    Singapore, Central Singapore, 308433

  • National University Hospital /ID# 264016

    Singapore, 119074

Other trials in Singapore

Mexico2 sites

  • Centro de Quimioterapia E Investigacion Sas de Cv /Id# 263293

    Jalisco, 45645

  • Centro De Investigación Clinica Chapultepec /ID# 243959

    Mexico City, Mexico City, 04100

Other trials in Mexico

New Zealand2 sites

  • North Shore Hospital /ID# 266060

    Auckland, 0622

  • Wellington Hospital /ID# 265966

    Wellington, 6021

Other trials in New Zealand

Canada1 site

  • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 262751

    Montreal, Quebec, H1T 2M4

Other trials in Canada

About this study

Official title: 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.

Read more

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.

Being tested
Epcoritamab, Rituximab, Lenalidomide, Oxaliplatin, Gemcitabine
Keywords
Epcoritamab, Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin, Diffuse Large B-Cell Lymphoma, DLBCL, Epkinly, ABBV-GMAB-3013
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06508658
Study groupRoleWhat they receive
Arm A: Epcoritamab Plus Lenalidomide (E-Len)ExperimentalParticipants will receive E-Len for up to 12 cycles (each cycle is 28 days).
Receives: Drug: Epcoritamab; Drug: Lenalidomide
Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx)ExperimentalParticipants will receive R-GemOx for up to 4 cycles (each cycle is 28 days)
Receives: Drug: Rituximab; Drug: Oxaliplatin; Drug: Gemcitabine
Arm C: EpcoritamabExperimentalParticipants will receive epcoritamab for up to 12 cycles (each cycle is 28 days).
Receives: Drug: Epcoritamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arm A vs Arm B: Progression-Free Survival (PFS)

    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.

    Measured: Up to 4 Years

Secondary outcomes (3)

  1. Arm A vs Arm B: Percentage of Participants Who Achieve Complete response (CR)

    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.

    Measured: Up to 4 Years

  2. Arm A vs Arm B: Overall Survival (OS)

    OS is defined as the time from randomization to death from any cause.

    Measured: Up to 4 Years

  3. Arm A vs Arm B: Percentage of Participants Who Achieve Minimal Residual Disease (MRD) Negativity Rate

    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.

    Measured: Up to 4 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2024
  2. Study start13 Aug 2024
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
379 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06508658
Sponsor's protocol ID
M22-128
Other IDs
2024-510965-41
Acronym
EPCORE DLBCL-4
Status last verified
Apr 2026
First submitted
11 Jul 2024
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epcoritamab, Rituximab and Lenalidomide in people with Diffuse Large B-Cell Lymphoma, run by Genmab at 176 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in China, United States, Japan, South Korea, Turkey (Türkiye) and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arm A vs Arm B: Progression-Free Survival (PFS) (time frame: Up to 4 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06508658.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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