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A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Enzastaurin Plus R-CHOP Versus R-CHOP in Treatment-Naive Subjects With High-Risk Diffuse Large B-Cell Lymphoma Who Possess the Novel Genomic Biomarker DGM1?

Investigating the Effect of an Investigational Medication with R-CHOP on Survival in High-Risk Diffuse Large B-Cell Lymphoma

Recruiting
18 years and older
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study investigates the effects of an investigational medication combined with R-CHOP treatment on overall survival in patients with high-risk Diffuse Large B-Cell Lymphoma (DLBCL) who have a specific biomarker called DGM1. DLBCL is a type of cancer that affects white blood cells. The study aims to see if adding the investigational medication to the standard R-CHOP treatment can improve survival outcomes for these patients.

Participants in this study will be randomly assigned to receive either the investigational medication with R-CHOP or a placebo with R-CHOP. They will undergo up to 6 cycles of treatment, with each cycle lasting 3 weeks. The response to the treatment will be evaluated using PET/CT scans. Those who respond well to the investigational medication may continue receiving it as maintenance therapy for up to 2 additional years.

  • Who can participate: Adults with CD20-positive Diffuse Large B-Cell Lymphoma who have not received prior treatment for lymphoma can participate if they have adequate organ function and are willing to use contraception. Participants should not have CNS involvement or significant health disorders that interfere with the study.
  • Study details: Participants will take part in a randomized study where they will either receive the investigational medication with R-CHOP or a placebo with R-CHOP. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. Participants must be able to swallow tablets and agree to follow-up visits.
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Study details
    Diffuse Large B-Cell Lymphoma

TX8981

19 February 2024

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