Study on Epcoritamab with R-CHOP for Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

Sponsor: Genmab

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05578976

Provider View

This clinical trial is testing a new treatment combination of Epcoritamab with R-CHOP chemotherapy to see if it can better control disease activity in adults with newly diagnosed Diffuse Large B-Cell Lymphoma (DLBCL).

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 evaluate how well the investigational drug Epcoritamab, when combined with the standard chemotherapy regimen R-CHOP, can control the disease in adults with newly diagnosed DLBCL. Participants will be divided into two groups: one group will receive Epcoritamab with R-CHOP, followed by Epcoritamab alone, while the other group will receive R-CHOP followed by Rituximab. The study will involve about 900 participants worldwide, and they will undergo regular medical assessments to monitor the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Must be planned to receive 6 cycles of standard R-CHOP treatment.
  • Must have a new diagnosis of CD20+ DLBCL confirmed by a recent biopsy.
  • Must have one of the following types of DLBCL:
    • DLBCL, Not Otherwise Specified (NOS)
    • High grade B-cell lymphoma with specific genetic changes
    • T-cell/histiocyte-rich large B-cell lymphoma
    • Epstein Barr virus-positive DLBCL, NOS
    • Follicular lymphoma Grade 3b
  • Must have a pathology report available at screening.
  • Must not have certain other types of lymphoma.
  • Must provide a tissue sample at screening.
  • Must have an International Prognostic Index (IPI) score of 2-5.
  • Must have an ECOG performance status score of 0-2 before starting R-CHOP.
  • Must have at least one measurable tumor on a scan.
  • Must meet specific laboratory criteria.
  • Must have a heart function of at least 50% as measured by specific tests.

Exclusion Criteria

  • Cannot have had previous systemic treatment for DLBCL, except for certain pre-phase treatments.
  • Cannot have significant heart disease as defined by the study protocol.

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