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?

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Updated on 19 February 2024

Summary

The purpose of this study is to compare the effect of RCHOP/enzastaurin versus R-CHOP on overall survival (OS) in treatment-naive, high-risk subjects with Diffuse Large B-Cell Lymphoma (DLBCL) who possess the DGM1 biomarker.

Description

This randomized, placebo-controlled phase 3 study is planned to enroll approximately 235 treatment-na?ve subjects with high-risk Diffuse Large B-Cell Lymphoma (DLBCL). Subjects will be randomized 1:1 to R-CHOP plus enzastaurin or R CHOP (plus placebo during induction). All subjects will receive up to 6 cycles (3 weeks per cycle) of treatment. PET/ CT will be used to assess radiographic response at the end of treatment. Each subject's treatment assignment will be unblinded after initial phase of treatment. Subjects randomized to the enzastaurin arm who have a response will be offered maintenance treatment of the study drug for up to 2 additional years.
Participants will not be paid for their participation.

FAQ

Participants will not be paid for their participation.

Details
Condition Diffuse Large B-Cell Lymphoma
Age 18years - 100years
Clinical Study IdentifierTX8981
Last Modified on19 February 2024

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