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
NCT ID: NCT06508658
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2024-08-13
2028-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Epcoritamab Plus Lenalidomide (E-Len)
Participants will receive E-Len for up to 12 cycles (each cycle is 28 days).
Epcoritamab
Subcutaneous Injection
Lenalidomide
Oral Capsule
Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx)
Participants will receive R-GemOx for up to 4 cycles (each cycle is 28 days)
Rituximab
Intravenous (IV) Infusion
Oxaliplatin
IV Infusion
Gemcitabine
IV Infusion
Arm C: Epcoritamab
Participants will receive epcoritamab for up to 12 cycles (each cycle is 28 days).
Epcoritamab
Subcutaneous Injection
Interventions
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Epcoritamab
Subcutaneous Injection
Rituximab
Intravenous (IV) Infusion
Lenalidomide
Oral Capsule
Oxaliplatin
IV Infusion
Gemcitabine
IV Infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Genmab
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Université 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, , Brazil
Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 263944
São Paulo, , Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 242425
São Paulo, , Brazil
UMHAT Sveti Georgi /ID# 242905
Plovdiv, , Bulgaria
UMHAT Sveti Ivan Rilski /ID# 242389
Sofia, , Bulgaria
SHAT Hematologic Diseases /ID# 242708
Sofia, , Bulgaria
UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 262761
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
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 243137
Hangzhou, Zhejiang, China
Zhejiang Cancer hospital /ID# 242711
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
Fakultní nemocnice v Motole /ID# 272378
Prague, Praha 5, Czechia
Fakultni nemocnice Olomouc /ID# 262832
Olomouc, , Czechia
Institut de cancérologie Strasbourg Europe (ICANS) /ID# 264068
Strasbourg, Bas-Rhin, 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 Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 242039
Athens, , Greece
General University Hospital of Thessaloniki AXEPA /ID# 242038
Thessaloniki, , Greece
Theageneio Anticancer Hospital /ID# 242036
Thessaloniki, , Greece
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 262924
Pécs, Baranya, 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
Semmelweis Egyetem /ID# 242455
Budapest, , Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 262923
Budapest, , 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 Investigación Clinica Chapultepec /ID# 243959
Mexico City, Mexico City, Mexico
Centro de Quimioterapia E Investigacion Sas de Cv /Id# 263293
Jalisco, , 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, , New Zealand
Wellington Hospital /ID# 265966
Wellington, , 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, , Portugal
Unidade Local de Saude Sao Joao, EPE /ID# 262962
Porto, , 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
National Taiwan University Hospital /ID# 243300
Taipei City, Taipei, Taiwan
China Medical University Hospital /ID# 242931
Taichung, , Taiwan
Taichung Veterans General Hospital /ID# 242937
Taichung, , Taiwan
National Cheng Kung University Hospital /ID# 243301
Tainan, , Taiwan
Ankara Universitesi Fakultesi /ID# 242410
Ankara, , Turkey (Türkiye)
Adnan Menderes University /ID# 242418
Aydin, , Turkey (Türkiye)
Trakya University Medical Facu /ID# 242419
Edirne, Istanbul, , Turkey (Türkiye)
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 242414
Istanbul, , Turkey (Türkiye)
Vehbi Koc vakfi Amerikan Hasta /ID# 242415
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty /ID# 242417
Izmir, , Turkey (Türkiye)
Ondokuz mayis University Facul /ID# 242412
Samsun, , Turkey (Türkiye)
Istanbul Florence Nightingale Hospital /ID# 271544
Şişli, , Turkey (Türkiye)
Karadeniz Technical University Farabi Hospital /ID# 264694
Trabzon, , Turkey (Türkiye)
Royal Cornwall Hospital /ID# 265130
Truro, Cornwall, United Kingdom
NHS Lanarkshire /ID# 272332
Airdrie, North Lanarkshire, United Kingdom
Nottingham City Hospital /ID# 265129
Nottingham, Nottinghamshire, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 242923
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2024-510965-41
Identifier Type: OTHER
Identifier Source: secondary_id
M22-128
Identifier Type: -
Identifier Source: org_study_id
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