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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
MinorTrial status changed: Recruiting → Active, Not RecruitingPrimary and study completion pushed from Jan 2028 to Mar 2028 · Enrollment target: estimated 360 to confirmed 379 · Study sites: 177 to 176v19Show 3 more changesShow less
Primary and study completion pushed from Jan 2028 to Mar 2028
NotablePrimary endpoint revisedEnrollment target: 320 to 360 · Study sites: 122 to 143 · Secondary endpoints revised (3) · 3 morev9Show 6 more changesShow less
MinorStudy sites: 53 to 66Primary and study completion dates: Jan 17, 2028 to Jan 2028v5Show 1 more changeShow less
Primary and study completion dates: Jan 17, 2028 to Jan 2028
MinorStudy sites: 27 to 53v4
MinorStudy sites: 8 to 27v3
NotableTrial status: Not Yet Recruiting to RecruitingEnrollment target: 360 to 320 · Study sites: 0 to 8 · Primary completion date: Nov 28, 2027 to Jan 17, 2028 · 1 morev2Show 4 more changesShow less
Enrollment target: 360 to 320
Study sites: 0 to 8
Primary completion date: Nov 28, 2027 to Jan 17, 2028
Start date changed from estimate of Aug 30, 2024 to Aug 13, 2024
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.