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

Last updated: March 3, 2025
Sponsor: Genmab
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphoma, B-cell

Lymphoma

Hematologic Cancer

Treatment

Lenalidomide

Epcoritamab

Gemcitabine

Clinical Study ID

NCT06508658
M22-128
2024-510965-41-00
  • Ages > 18
  • All Genders

Study 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 2 groups, called treatment arms. Each group receives a different treatment. Around 320 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 intrav... (IV) infused R-GemOx for up to 4 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 Criteria

Inclusion

Inclusion Criteria:

  • Eastern Cooperative Oncology Group Performance status score of 0 to 2.

  • Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documentedin the most recent and representative pathology report, inclusive of the followingaccording to the World Health Organization (WHO) 2022 as per the protocol.

  • Must have relapsed or refractory (R/R) disease and have been previously treated withat least 1 line of systemic antineoplastic therapy including anti-CD20mAb-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 afterASCT or been refractory to ASCT.

  • Not be considered a candidate for ASCT due to age, performance status,comorbidities and/or insufficient response to prior treatment, or have refusedASCT.

  • 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 inthe study

Exclusion

Exclusion Criteria:

  • Current evidence of primary central nervous system (CNS) lymphoma or known CNSinvolvement by lymphoma including leptomeningeal disease, at screening.

  • History of prior treatment with a bispecific antibody targeting CD3 and CD20 orprior treatment with rituximab plus gemcitabine and oxaliplatin (R-GemOx) orgemcitabine and oxaliplatin (GemOx).

  • Documented refractoriness to lenalidomide.

Study Design

Total Participants: 320
Treatment Group(s): 5
Primary Treatment: Lenalidomide
Phase: 3
Study Start date:
August 13, 2024
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • Canberra Hospital /ID# 265312

    Canberra, Australian Capital Territory 2605
    Australia

    Active - Recruiting

  • Royal Prince Alfred Hospital /ID# 263242

    Sydney, New South Wales 2050
    Australia

    Active - Recruiting

  • Wollongong Hospital /ID# 244646

    Wollongong, New South Wales 2500
    Australia

    Active - Recruiting

  • Toowoomba Hospital /ID# 263243

    Toowoomba, Queensland 4350
    Australia

    Active - Recruiting

  • Monash Health - Monash Medical Centre /ID# 262783

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Medical Centre /ID# 262783

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Royal Perth Hospital /ID# 243790

    Perth, Western Australia 6000
    Australia

    Active - Recruiting

  • Universitair Ziekenhuis Brussel /ID# 242574

    Jette, Bruxelles-Capitale 1090
    Belgium

    Active - Recruiting

  • Centre Hospitalier Epicura - site d'Hornu /ID# 265148

    Boussu, Hainaut 7301
    Belgium

    Active - Recruiting

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

    Yvoir, Namur 5530
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Leuven /ID# 246671

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • AZ-Delta /ID# 264740

    Roeselare, West-Vlaanderen 8800
    Belgium

    Active - Recruiting

  • UMHAT Sveti Georgi /ID# 242905

    Plovdiv, 4002
    Bulgaria

    Active - Recruiting

  • SHAT Hematologic Diseases /ID# 242708

    Sofia, 1797
    Bulgaria

    Active - Recruiting

  • UMHAT Sveti Ivan Rilski /ID# 242389

    Sofia, 1431
    Bulgaria

    Active - Recruiting

  • UMHAT Sveta Marina /ID# 262761

    Varna, 9010
    Bulgaria

    Active - Recruiting

  • Peking University Third Hospital /ID# 242941

    Beijing, Beijing 100191
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital /ID# 242942

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

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

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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

    Shijiazhuang, Hebei 050000
    China

    Active - Recruiting

  • Hubei Cancer Hospital /ID# 242963

    Wuhan, Hubei 430079
    China

    Active - Recruiting

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

    Wuhan, Hubei 430022
    China

    Active - Recruiting

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

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • The First Hospital of Jilin University /ID# 242940

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • Shandong Cancer Hospital /ID# 264036

    Jinan, Shandong 250117
    China

    Active - Recruiting

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

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

  • Tianjin Cancer Hospital /ID# 243940

    Tianjin, Tianjin 300000
    China

    Active - Recruiting

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

    Urumqi, Xinjiang 830000
    China

    Active - Recruiting

  • The second affiliated hospital of Zhejiang University school of medicine /ID# 243137

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

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

    Wenzhou, Zhejiang 325000
    China

    Active - Recruiting

  • Klinicka bolnica Merkur /ID# 262619

    Zagreb, Grad Zagreb 10000
    Croatia

    Active - Recruiting

  • Klinicki bolnicki centar Sestre milosrdnice /ID# 262620

    Zagreb, Grad Zagreb 10000
    Croatia

    Active - Recruiting

  • Klinicki bolnicki centar Zagreb /ID# 262617

    Zagreb, Grad Zagreb 10000
    Croatia

    Active - Recruiting

  • Klinicki bolnicki centar Osijek /ID# 262621

    Osijek, Osjecko-baranjska Zupanija 31000
    Croatia

    Active - Recruiting

  • Klinički Bolnički Centar Rijeka /ID# 266004

    Rijeka, Primorsko-goranska Zupanija 51000
    Croatia

    Active - Recruiting

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

    Split, Splitsko-dalmatinska Zupanija 21000
    Croatia

    Active - Recruiting

  • Fakultní nemocnice Hradec Králové - Sokolská /ID# 264071

    Hradec Králové, Hradec Kralove 500 05
    Czechia

    Active - Recruiting

  • CHRU Tours - Hopital Bretonneau /ID# 244580

    Tours CEDEX 9, Indre-et-Loire 37044
    France

    Active - Recruiting

  • Centre Hospitalier D'Avignon /ID# 243072

    Avignon, Provence-Alpes-Cote-d Azur 84000
    France

    Active - Recruiting

  • Centre Hospitalier de la Cote Basque /ID# 243065

    Bayonne, Pyrenees-Atlantiques 64100
    France

    Active - Recruiting

  • CHU Poitiers - La miletrie /ID# 243074

    Poitiers, Vienne 86000
    France

    Active - Recruiting

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

    Caen, 14033
    France

    Active - Recruiting

  • Hopital Saint Vincent de Paul /ID# 243070

    Lille Cedex, 59020
    France

    Active - Recruiting

  • Institut de cancérologie Strasbourg Europe (ICANS) /ID# 264068

    Strasbourg, 67200
    France

    Active - Recruiting

  • General Hospital of Athens Laiko /ID# 262809

    Athens, Attiki 11527
    Greece

    Active - Recruiting

  • University General Hospital Attikon /ID# 242041

    Athens, Attiki 12462
    Greece

    Active - Recruiting

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

    Athens, 10676
    Greece

    Active - Recruiting

  • General University Hospital of Thessaloniki AXEPA /ID# 242038

    Thessaloniki, 54636
    Greece

    Active - Recruiting

  • Theageneio Anticancer Hospital /ID# 242036

    Thessaloniki, 54639
    Greece

    Active - Recruiting

  • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 262924

    Pecs, Baranya 7624
    Hungary

    Active - Recruiting

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

    Gyor, Gyor-Moson-Sopron 9024
    Hungary

    Active - Recruiting

  • Debreceni Egyetem-Klinikai Kozpont /ID# 242451

    Debrecen, Hajdu-Bihar 4032
    Hungary

    Active - Recruiting

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

    Nyiregyhaza, Szabolcs-Szatmar-Bereg 4400
    Hungary

    Active - Recruiting

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

    Budapest, 1097
    Hungary

    Active - Recruiting

  • Orszagos Onkologiai Intezet /ID# 242457

    Budapest, 1122
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem /ID# 242455

    Budapest, 1085
    Hungary

    Active - Recruiting

  • Fujita Health University Hospital /ID# 265968

    Toyoake, Aichi 470-1192
    Japan

    Active - Recruiting

  • National Hospital Organization Shikoku Cancer Center /ID# 265977

    Matsuyama, Ehime 791-0280
    Japan

    Active - Recruiting

  • Kyushu University Hospital /ID# 267624

    Fukuoka-shi, Fukuoka 812-8582
    Japan

    Active - Recruiting

  • Fukushima Medical University Hospital /ID# 264667

    Fukushima-shi, Fukushima 960-1295
    Japan

    Active - Recruiting

  • Sapporo Medical University Hospital /ID# 264928

    Sapporo, Hokkaido 060-8543
    Japan

    Active - Recruiting

  • Kagoshima University Hospital /ID# 248259

    Kagoshima-shi, Kagoshima 890-8520
    Japan

    Active - Recruiting

  • Tokai University Hospital /ID# 265433

    Isehara, Kanagawa 259-1193
    Japan

    Active - Recruiting

  • Kansai Medical University Hospital /ID# 266018

    Hirakata-shi, Osaka 573-1191
    Japan

    Active - Recruiting

  • Kindai University Hospital /ID# 265474

    Osakasayama-shi, Osaka 589-8511
    Japan

    Active - Recruiting

  • Saitama Cancer Center /ID# 265277

    Kitaadachi-gun, Saitama 362-0806
    Japan

    Active - Recruiting

  • University of Yamanashi Hospital /ID# 264671

    Chuo, Yamanashi 409-3898
    Japan

    Active - Recruiting

  • Dong-A University Medical Center /ID# 262841

    Busan, Busan Gwang Yeogsi 49201
    Korea, Republic of

    Active - Recruiting

  • Inje University - Busan Paik Hospital /ID# 262842

    Busan, Busan Gwang Yeogsi 47392
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital /ID# 242405

    Seongnam-si, Gyeonggido 13620
    Korea, Republic of

    Active - Recruiting

  • Keimyung University Dongsan Hospital /ID# 262840

    Daegu, Gyeongsangbugdo 42601
    Korea, Republic of

    Active - Recruiting

  • Jeonbuk National University Hospital /ID# 242958

    Jeonju, Jeonrabugdo 54907
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hwasun Hospital /ID# 262843

    Hwasun-gun, Jeonranamdo 58128
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center /ID# 242409

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center /ID# 242408

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital /ID# 242407

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Active - Recruiting

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

    Seoul, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Active - Recruiting

  • Ulsan University Hospital /ID# 242956

    Ulsan, Ulsan Gwang Yeogsi 44033
    Korea, Republic of

    Active - Recruiting

  • Medisch Centrum Leeuwarden /ID# 245501

    Leeuwarden, Friesland 8934 AD
    Netherlands

    Active - Recruiting

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

    's-Hertogenbosch, Noord-Brabant 5223 GZ
    Netherlands

    Active - Recruiting

  • OLVG - Locatie Oost /ID# 263355

    Amsterdam, Noord-Holland 1091 AC
    Netherlands

    Active - Recruiting

  • St. Antonius Ziekenhuis /ID# 245197

    Nieuwegein, Utrecht 3435 CM
    Netherlands

    Active - Recruiting

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 263361

    Dordrecht, Zuid-Holland 3318 AT
    Netherlands

    Active - Recruiting

  • North Shore Hospital /ID# 266060

    Auckland, 0622
    New Zealand

    Active - Recruiting

  • Wellington Hospital /ID# 265966

    Wellington, 6021
    New Zealand

    Active - Recruiting

  • Pratia MCM Krakow /ID# 262882

    Krakow, Malopolskie 30-727
    Poland

    Active - Recruiting

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

    Warsaw, Mazowieckie 02-781
    Poland

    Active - Recruiting

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

    Kielce, Swietokrzyskie 25-734
    Poland

    Active - Recruiting

  • Aidport sp z o.o. /ID# 262766

    Poznan, Wielkopolskie 60-175
    Poland

    Active - Recruiting

  • Hospital da Luz /ID# 262965

    Lisbon, Lisboa 1500-650
    Portugal

    Active - Recruiting

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

    Porto, 4200-072
    Portugal

    Active - Recruiting

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

    Porto, 4202-451
    Portugal

    Active - Recruiting

  • Fundeni Clinical Institute /ID# 266734

    Bucharest, Bucuresti 022328
    Romania

    Active - Recruiting

  • Institutul Oncologic Prof Dr I Chiricuta /ID# 243753

    Cluj Napoca, Cluj 400015
    Romania

    Active - Recruiting

  • Institutul Regional de Oncologie /ID# 244367

    Jassi, Iasi 700483
    Romania

    Active - Recruiting

  • Spitalul Clinic Coltea /ID# 243694

    Bucharest, 030171
    Romania

    Active - Recruiting

  • Clinical Hospital Center - Bežanijska Kosa /ID# 263053

    Belgrade, Beograd 11080
    Serbia

    Active - Recruiting

  • Clinical Hospital Center Zvezdara /ID# 263059

    Belgrade, Beograd 11000
    Serbia

    Active - Recruiting

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

    Belgrade, Beograd 11000
    Serbia

    Active - Recruiting

  • University Clinical Center Serbia /ID# 263057

    Belgrade, Beograd 11000
    Serbia

    Active - Recruiting

  • University Clinical Center Nis /ID# 263701

    Niš, Nisavski Okrug 18300
    Serbia

    Active - Recruiting

  • Institute for Oncology of Vojvodina /ID# 263052

    Sremska Kamenica, Vojvodina 21208
    Serbia

    Active - Recruiting

  • University Clinical Center Vojvodina /ID# 264138

    Novi Sad, 21000
    Serbia

    Active - Recruiting

  • National Cancer Centre Singapore /ID# 267015

    Singapore, Central Singapore 169611
    Singapore

    Active - Recruiting

  • National University Hospital /ID# 264016

    Singapore, 119074
    Singapore

    Active - Recruiting

  • Alberts Cellular Therapy /ID# 262720

    Pretoria, Gauteng 0044
    South Africa

    Active - Recruiting

  • Haemalife Inc. /ID# 262719

    Kuilsrivier, Western Cape 7580
    South Africa

    Active - Recruiting

  • National Taiwan University Hospital /ID# 243300

    Taipei City, Taipei 100
    Taiwan

    Active - Recruiting

  • China Medical University Hospital /ID# 242931

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital /ID# 242937

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital /ID# 243301

    Tainan, 704
    Taiwan

    Active - Recruiting

  • Adnan Menderes University /ID# 242418

    Aydin, 09100
    Turkey

    Active - Recruiting

  • Trakya University Medical Facu /ID# 242419

    Edirne, Istanbul, 22030
    Turkey

    Active - Recruiting

  • Ondokuz mayis University Facul /ID# 242412

    Samsun, 55200
    Turkey

    Active - Recruiting

  • Nottingham City Hospital /ID# 265129

    Nottingham, Nottinghamshire NG5 1PB
    United Kingdom

    Active - Recruiting

  • Valkyrie Clinical Trials /ID# 269935

    Los Angeles, California 90067
    United States

    Active - Recruiting

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

    Golden, Colorado 80401
    United States

    Active - Recruiting

  • Northwest Cancer Center - Dyer Clinic /ID# 269787

    Dyer, Indiana 46311
    United States

    Active - Recruiting

  • Cancer Center of Kansas - Wichita /ID# 270117

    Wichita, Kansas 67214
    United States

    Active - Recruiting

  • Gulfport Memorial Hospital /ID# 268104

    Gulfport, Mississippi 39501
    United States

    Active - Recruiting

  • New York Medical College /ID# 265799

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • Thompson Cancer Survival Ctr /ID# 242149

    Knoxville, Tennessee 37916
    United States

    Active - Recruiting

  • Community Cancer Trials Of Utah /ID# 271715

    Ogden, Utah 84405
    United States

    Active - Recruiting

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