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?

Study Overview

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.

Study 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.

Additional Information

Participants will not be paid for their participation.


  • IRB Number: 1805400146 (DB102-02)
  • Research Study Identifier: TX8981
  • Principal Investigator: Michael Robertson, MD

Recruitment Status

Open

Contact the research team to learn more about this study.

Fields marked with asterisk (*) are required

Please verify that you are not a bot.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.

Volunteer Sign up

Volunteer Registry

Create your profile and be matched to research opportunities

Register Now!

Contact Us

If you need help finding a study or have any questions, please contact us at inhealth@iu.edu or by phone at (888) 264-0005.