RecruitingPhase 3NCT06508658

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, 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

Sponsor

Genmab

Enrollment

360 participants

Start Date

Aug 13, 2024

Study Type

INTERVENTIONAL

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 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment options for adults with diffuse large B-cell lymphoma (DLBCL) — an aggressive type of lymphoma — that has come back or stopped responding to treatment. It compares a new combination (epcoritamab plus lenalidomide, both given under the skin or by mouth) against a standard chemotherapy regimen (rituximab plus gemcitabine and oxaliplatin, all given by IV). **You may be eligible if...** - You are an adult with confirmed DLBCL (or related subtypes) that has relapsed or is no longer responding to treatment - You have received at least one prior line of treatment including a rituximab-based combination chemotherapy - You are in reasonably good overall health (ECOG 0–2) **You may NOT be eligible if...** - You have never been treated for DLBCL before - You have severe organ problems that prevent chemotherapy - You have active central nervous system involvement by lymphoma - You have certain other serious health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEpcoritamab

Subcutaneous Injection

DRUGRituximab

Intravenous (IV) Infusion

DRUGLenalidomide

Oral Capsule

DRUGOxaliplatin

IV Infusion

DRUGGemcitabine

IV Infusion

Locations(177)

City of Hope National Medical Center /ID# 273338

Duarte, California, United States

Valkyrie Clinical Trials /ID# 269935

Los Angeles, California, United States

Desert Regional Medical Center /ID# 272437

Palm Springs, California, United States

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

Golden, Colorado, United States

City Of Hope - Atlanta. /ID# 273092

Newnan, Georgia, United States

Rush University Medical Center /ID# 242103

Chicago, Illinois, United States

City Of Hope - Chicago /ID# 274430

Zion, Illinois, United States

Northwest Cancer Center - Dyer Clinic /ID# 269787

Dyer, Indiana, United States

Cancer Center of Kansas - Wichita /ID# 270117

Wichita, Kansas, United States

University of Kentucky Chandler Medical Center. /ID# 242087

Lexington, Kentucky, United States

University of Maryland, Baltimore /ID# 242216

Baltimore, Maryland, United States

Henry Ford Hospital /ID# 266446

Detroit, Michigan, United States

Gulfport Memorial Hospital /ID# 268104

Gulfport, Mississippi, United States

New York Medical College /ID# 265799

Valhalla, New York, United States

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

Greenville, North Carolina, United States

Thompson Cancer Survival Ctr /ID# 242149

Knoxville, Tennessee, United States

Community Cancer Trials Of Utah /ID# 271715

Ogden, Utah, United States

Utah Cancer Specialists - Salt Lake City /ID# 268603

Salt Lake City, Utah, United States

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

Salt Lake City, Utah, United States

Hospital Universitario Austral /ID# 242791

Pilar, Buenos Aires, Argentina

Fundaleu /Id# 242789

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

Instituto Alexander Fleming /ID# 263804

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

Canberra Hospital /ID# 265312

Garran, Australian Capital Territory, Australia

Royal Prince Alfred Hospital /ID# 263242

Sydney, New South Wales, Australia

Wollongong Hospital /ID# 244646

Wollongong, New South Wales, Australia

Toowoomba Hospital /ID# 263243

Toowoomba, Queensland, Australia

Monash Health - Monash Medical Centre /ID# 262783

Clayton, Victoria, Australia

Royal Perth Hospital /ID# 243790

Perth, Western Australia, Australia

Universitair Ziekenhuis Brussel /ID# 242574

Jette, Brussels Capital, Belgium

Centre Hospitalier Epicura - Hornu /ID# 265148

Boussu, Hainaut, Belgium

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

Yvoir, Namur, Belgium

Universitair Ziekenhuis Leuven /ID# 246671

Leuven, Vlaams-Brabant, Belgium

AZ-Delta. /ID# 264740

Roeselare, West-Vlaanderen, Belgium

Hospital Sao Rafael /ID# 262949

Salvador, Estado de Bahia, Brazil

Hospital Erasto Gaertner /ID# 264049

Curitiba, Puerto Rico, Brazil

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

Ribeirão Preto, São Paulo, Brazil

Hospital Alemao Oswaldo Cruz /ID# 247418

São Paulo, São Paulo, Brazil

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

São Paulo, São Paulo, Brazil

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

São Paulo, São Paulo, Brazil

UMHAT Sveti Georgi /ID# 242905

Plovdiv, Plovdiv, Bulgaria

UMHAT Sveti Ivan Rilski /ID# 242389

Sofia, Sofia, Bulgaria

SHAT Hematologic Diseases /ID# 242708

Sofia, Sofia, Bulgaria

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

Varna, Varna, Bulgaria

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

Montreal, Quebec, Canada

Fundacion Arturo Lopez Perez /ID# 242421

Providencia, Santiago Metropolitan, Chile

Bradford Hill /ID# 262795

Santiago, Santiago Metropolitan, Chile

Clinica Alemana de Santiago /ID# 244139

Santiago, Chile

Peking University Third Hospital /ID# 242941

Beijing, Beijing Municipality, China

Fujian Province Cancer Hospital /ID# 265075

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen /ID# 264305

Xiamen, Fujian, China

Sun Yat-Sen University Cancer Center /ID# 242712

Guangzhou, Guangdong, China

Guangdong Provincial Peoples Hospital /ID# 242942

Guangzhou, Guangdong, China

The Second Hospital of Hebei Medical University /ID# 242944

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital /Id# 242961

Harbin, Heilongjiang, China

Henan Cancer Hospital /ID# 242700

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

Hubei Cancer Hospital /ID# 242963

Wuhan, Hubei, China

Jiangsu Peoples Hospital /ID# 271924

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University /ID# 242939

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University /ID# 242703

Nanchang, Jiangxi, China

Jiangxi Provincial Cancer Hospital /ID# 242968

Nanchang, Jiangxi, China

The First Hospital of Jilin University /ID# 242940

Changchun, Jilin, China

First Affiliated Hospital of China Medical University /ID# 242701

Shenyang, Liaoning, China

Shandong Cancer Hospital /ID# 264036

Jinan, Shandong, China

Shanghai Tongji Hospital /ID# 263952

Shanghai, Shanghai Municipality, China

Tianjin Cancer Hospital /ID# 243940

Tianjin, Tianjin Municipality, China

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

Tianjin, Tianjin Municipality, China

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

Ürümqi, Xinjiang, China

Yunnan Province Cancer Hospital /ID# 264057

Kunming, Yunnan, China

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

Hangzhou, Zhejiang, China

Zhejiang Cancer hospital /ID# 242711

Hangzhou, Zhejiang, China

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

Hangzhou, Zhejiang, China

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

Wenzhou, Zhejiang, China

Klinicka bolnica Merkur /ID# 262619

Zagreb, City of Zagreb, Croatia

Klinicki bolnicki centar Sestre milosrdnice /ID# 262620

Zagreb, City of Zagreb, Croatia

Klinicki bolnicki centar Zagreb /ID# 262617

Zagreb, City of Zagreb, Croatia

Klinicki bolnicki centar Osijek /ID# 262621

Osijek, County of Osijek-Baranja, Croatia

Klinički Bolnički Centar Rijeka /ID# 266004

Rijeka, Primorje-Gorski Kotar County, Croatia

Klinicki Bolnicki Centar (KBC) Split /ID# 262618

Split, Split-Dalmatia County, Croatia

Fakultní nemocnice Hradec Králové - Sokolská /ID# 264071

Hradec Králové, Hradec Kralove, Czechia

Fakultni nemocnice Olomouc /ID# 262832

Olomouc, Olomouc, Czechia

Fakultní nemocnice v Motole /ID# 272378

Prague, Praha 5, Czechia

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

Strasbourg, Alsace, France

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

Caen, Calvados, France

CHRU Tours - Hopital Bretonneau /ID# 244580

Tours, Indre-et-Loire, France

Centre Hospitalier D'Avignon /ID# 243072

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

Centre Hospitalier de la Cote Basque /ID# 243065

Bayonne, Pyrenees-Atlantiques, France

CHU Poitiers - La miletrie /ID# 243074

Poitiers, Vienne, France

Hopital Saint Vincent de Paul /ID# 243070

Lille, France

General Hospital of Athens Laiko /ID# 262809

Athens, Attica, Greece

University General Hospital Attikon /ID# 242041

Athens, Attica, Greece

General University Hospital of Thessaloniki AXEPA /ID# 242038

Thessaloniki, Thessaloniki, Greece

Theageneio Anticancer Hospital /ID# 242036

Thessaloniki, Thessaloniki, Greece

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

Athens, Greece

Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 262924

Pécs, Baranya, Hungary

Semmelweis Egyetem /ID# 242455

Budapest, Budapest, Hungary

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

Budapest, Budapest, Hungary

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

Győr, Győr-Moson-Sopron, Hungary

Debreceni Egyetem-Klinikai Kozpont /ID# 242451

Debrecen, Hajdú-Bihar, Hungary

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 242468

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

Orszagos Onkologiai Intezet /ID# 242457

Budapest, Hungary

Fujita Health University Hospital /ID# 265968

Toyoake, Aichi-ken, Japan

National Hospital Organization Shikoku Cancer Center /ID# 265977

Matsuyama, Ehime, Japan

Kyushu University Hospital /ID# 267624

Fukuoka, Fukuoka, Japan

Fukushima Medical University Hospital /ID# 264667

Fukushima, Fukushima, Japan

Sapporo Medical University Hospital /ID# 264928

Sapporo, Hokkaido, Japan

Hyogo Prefectural Amagasaki General Medical Center /ID# 277258

Amagasaki, Hyōgo, Japan

Kagoshima University Hospital /ID# 248259

Kagoshima, Kagoshima-ken, Japan

Tokai University Hospital /ID# 265433

Isehara, Kanagawa, Japan

Shonankamakura General Hospital /ID# 277671

Kamakura, Kanagawa, Japan

Kansai Medical University Hospital /ID# 266018

Hirakata-shi, Osaka, Japan

Kindai University Hospital /ID# 265474

Sakai-shi, Osaka, Japan

Duplicate_Saitama Cancer Center /ID# 265277

Kitaadachi-gun, Saitama, Japan

University of Yamanashi Hospital /ID# 264671

Chuo-shi, Yamanashi, Japan

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

Jalisco, Jalisco, Mexico

Centro De Investigación Clinica Chapultepec /ID# 243959

Mexico City, Mexico City, Mexico

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

's-Hertogenbosch, North Brabant, Netherlands

OLVG - Locatie Oost /ID# 263355

Amsterdam, North Holland, Netherlands

Medisch Centrum Leeuwarden /ID# 245501

Leeuwarden, Provincie Friesland, Netherlands

Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 263361

Dordrecht, South Holland, Netherlands

St. Antonius Ziekenhuis /ID# 245197

Nieuwegein, Utrecht, Netherlands

North Shore Hospital /ID# 266060

Auckland, Auckland, New Zealand

Wellington Hospital /ID# 265966

Wellington, Wellington Region, New Zealand

Aidport sp z o.o. /ID# 262766

Poznan, Greater Poland Voivodeship, Poland

Pratia MCM Krakow /ID# 262882

Krakow, Lesser Poland Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

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

Kielce, Świętokrzyskie Voivodeship, Poland

Hospital da Luz /ID# 262965

Lisbon, Lisbon District, Portugal

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

Porto, Porto District, Portugal

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

Porto, Porto District, Portugal

Fundeni Clinical Institute /ID# 266734

Bucharest, București, Romania

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

Cluj-Napoca, Cluj, Romania

Institutul Regional de Oncologie /ID# 244367

Iași, Iaşi, Romania

Spitalul Clinic Coltea /ID# 243694

Bucharest, Romania

Clinical Hospital Center Zvezdara /ID# 263059

Belgrade, Beograd, Serbia

Institute for Oncology and Radiology of Serbia /ID# 263055

Belgrade, Beograd, Serbia

University Clinical Center Serbia /ID# 263057

Belgrade, Beograd, Serbia

Clinical Hospital Center - Bežanijska Kosa /ID# 263053

Belgrade, Beograd, Serbia

University Clinical Center Nis /ID# 263701

Niš, Nisavski Okrug, Serbia

Institute for Oncology of Vojvodina /ID# 263052

Kamenitz, Vojvodina, Serbia

University Clinical Center Vojvodina /ID# 264138

Novi Sad, Serbia

National Cancer Centre Singapore /ID# 267015

Singapore, Central Singapore, Singapore

National University Hospital /ID# 264016

Singapore, Singapore

Tan Tock Seng Hospital /ID# 266061

Singapore, Singapore

Wits Clinical Research /ID# 264656

Johannesburg, Gauteng, South Africa

Alberts Cellular Therapy /ID# 262720

Pretoria, Gauteng, South Africa

Capital Haematology Hospital /ID# 278955

Durban, KwaZulu-Natal, South Africa

Constantiaberg Haematology /ID# 273041

Cape Town, Western Cape, South Africa

Haemalife Inc. /ID# 262719

Kuils River, Western Cape, South Africa

Inje University - Busan Paik Hospital /ID# 262842

Busan, Busan Gwang Yeogsi, South Korea

Dong-A University Medical Center /ID# 262841

Busan, Busan Gwang Yeogsi, South Korea

Seoul National University Bundang Hospital /ID# 242405

Seongnam-si, Gyeonggido, South Korea

Keimyung University Dongsan Hospital /ID# 262840

Daegu, Gyeongsangbuk-do, South Korea

Jeonbuk National University Hospital /ID# 242958

Jeonju, Jeonrabugdo, South Korea

Chonnam National University Hwasun Hospital /ID# 262843

Hwasun-gun, Jeonranamdo, South Korea

Seoul National University Hospital /ID# 242407

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center /ID# 242409

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center /ID# 242408

Seoul, Seoul Teugbyeolsi, South Korea

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

Seoul, Seoul Teugbyeolsi, South Korea

Ulsan University Hospital /ID# 242956

Ulsan, Ulsan Gwang Yeogsi, South Korea

China Medical University Hospital /ID# 242931

Taichung, Taichung, Taiwan

Taichung Veterans General Hospital /ID# 242937

Taichung, Taichung, Taiwan

National Cheng Kung University Hospital /ID# 243301

Tainan, Tainan, Taiwan

National Taiwan University Hospital /ID# 243300

Taipei City, Taipei, Taiwan

Ankara Universitesi Fakultesi /ID# 242410

Ankara, Ankara, Turkey (Türkiye)

Adnan Menderes University /ID# 242418

Aydin, Aydın, Turkey (Türkiye)

Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 242414

Istanbul, Istanbul, Turkey (Türkiye)

Vehbi Koc vakfi Amerikan Hasta /ID# 242415

Istanbul, Istanbul, Turkey (Türkiye)

Ege University Medical Faculty /ID# 242417

Izmir, İzmir, Turkey (Türkiye)

Ondokuz mayis University Facul /ID# 242412

Samsun, Samsun, Turkey (Türkiye)

Karadeniz Technical University Farabi Hospital /ID# 264694

Trabzon, Trabzon, Turkey (Türkiye)

Trakya University Medical Facu /ID# 242419

Edirne, Istanbul, Turkey (Türkiye)

Istanbul Florence Nightingale Hospital /ID# 271544

Şişli, Turkey (Türkiye)

Royal Cornwall Hospital /ID# 265130

Truro, Cornwall, United Kingdom

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

Newcastle upon Tyne, Newcastle Upon Tyne, United Kingdom

NHS Lanarkshire /ID# 272332

Airdrie, North Lanarkshire, United Kingdom

Nottingham City Hospital /ID# 265129

Nottingham, Nottinghamshire, United Kingdom

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NCT06508658