Study to Assess Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™
Status:
Active, not recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
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.