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?
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.
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.
- IRB Number: 1805400146 (DB102-02)
- Research Study Identifier: TX8981
- Principal Investigator: Michael Robertson, MD
Contact the research team to learn more about this study.
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