Study Comparing Epcoritamab and Lenalidomide to Rituximab, Gemcitabine, and Oxaliplatin in Adults with Relapsed or Hard-to-Treat Diffuse Large B-Cell Lymphoma

Sponsor: Genmab

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06508658

Provider View

This clinical trial is testing two different treatment combinations to see which is more effective and safe for adults with Diffuse Large B-Cell Lymphoma that has returned or is difficult to treat. The study involves around 320 participants worldwide.

Patient Parameters

Program Overview

Diffuse Large B-Cell Lymphoma (DLBCL) is a rare and aggressive cancer affecting certain white blood cells. This study aims to compare the safety and effectiveness of two treatment combinations for adults with relapsed or refractory DLBCL. One group will receive epcoritamab and lenalidomide, while the other will receive rituximab, gemcitabine, and oxaliplatin. The study will monitor side effects and changes in the disease. Participants will be divided into two groups, each receiving a different treatment. The study will take place at approximately 165 sites globally, involving about 320 participants.

Eligibility Criteria

Inclusion Criteria

  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have a confirmed diagnosis of CD20+ Diffuse Large B-Cell Lymphoma (DLBCL).
  • Must have relapsed or refractory disease and have been treated with at least one previous therapy, including anti-CD20 chemotherapy.
  • Must meet at least one of the following:
    • Failed a previous stem cell transplant or is not a candidate for it.
    • Ineligible for CAR-T therapy due to health, logistics, or other constraints.
    • Relapsed after a previous CAR-T therapy.
  • Must have measurable disease.
  • Must have a life expectancy of more than 3 months with standard treatment.

Exclusion Criteria

  • Current or known involvement of the central nervous system by lymphoma.
  • Previous treatment with a bispecific antibody targeting CD3 and CD20, or with rituximab, gemcitabine, and oxaliplatin.
  • Documented resistance to lenalidomide.

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