DB102-02 (ENGINE) Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™ - Mercy Medical Center

DB102-02 (ENGINE) Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™

Posted on: January 30, 2020

This randomized, placebo-controlled phase 3 study is planned to enroll approximately 235 treatment-naïve 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. Includes being at least 18 years old and:

•Histologically-confirmed diagnosis of CD20-positive DLBCL based on the WHO classification (2016); the diagnosis must be confirmed at the enrolling site. Subjects with high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements and high-grade B-cell lymphoma, NOS are eligible.

•International Prognostic Index (IPI) score of at least 3

•Can not be receiving or has received radiation or any other systemic anticancer treatment for lymphoma

 

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