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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
379
Subcutaneous Injection
Intravenous (IV) Infusion
Oral Capsule
IV Infusion
IV Infusion
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
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.
Time frame: Up to 4 Years
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.
Time frame: Up to 4 Years
Arm A vs Arm B: Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Time frame: Up to 4 Years
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.
Time frame: Up to 4 Years
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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
...and 166 more locations