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
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.
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:
Must have measurable disease.
Life expectancy > 3 months on standard of care treatment at the time of enrolling in the study
Exclusion Criteria:
Golden, Colorado 80401, United States
Greenville, North Carolina 27834, United States
Salt Lake City, Utah 84108, United States
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1114, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1426, Argentina
Yvoir, Namur 5530, Belgium
Ribeirão Preto, São Paulo 14049-900, Brazil
São Paulo, 05403-000, Brazil
Montreal, Quebec H1T 2M4, Canada
Wuhan, Hubei 430048, China
Tianjin, Tianjin Municipality 300020, China
Ürümqi, Xinjiang 830000, China
Hangzhou, Zhejiang 310003, China
Hangzhou, Zhejiang 310052, China
Wenzhou, Zhejiang 325000, China
Hradec Králové, Hradec Kralove 500 05, Czechia
Strasbourg, Alsace 67200, France
Athens, 10676, Greece
Győr, Győr-Moson-Sopron 9024, Hungary
Nyíregyháza, Szabolcs-Szatmár-Bereg 4400, Hungary
Budapest, 1097, Hungary
Hirakata-shi, Osaka 573-1191, Japan
Sakai-shi, Osaka 590-0197, Japan
Kitaadachi-gun, Saitama 362-0806, Japan
Chuo-shi, Yamanashi 409-3898, Japan
's-Hertogenbosch, North Brabant 5223 GZ, Netherlands
Dordrecht, South Holland 3318 AT, Netherlands
Warsaw, Masovian Voivodeship 02-781, Poland
Kielce, Świętokrzyskie Voivodeship 25-734, Poland
Porto, 4200-072, Portugal
Cluj-Napoca, Cluj 400015, Romania
Daegu, Gyeongsangbuk-do 42601, South Korea
Hwasun-gun, Jeonranamdo 58128, South Korea
Seoul, Seoul Teugbyeolsi 06591, South Korea
Taipei City, Taipei 100, Taiwan
Edirne, Istanbul, 22030, Turkey (Türkiye)
Istanbul, 34098, Turkey (Türkiye)