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?

M
Michael Robertson, MD

Primary Investigator

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.

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.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Diffuse Large B-Cell Lymphoma
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria
Confirmed diagnosis of CD20-positive DLBCL
Adequate organ function
Willing to use an approved contraceptive method (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment
Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to start of treatment
Able to swallow tablets
Have adequate transportation to allow for required follow-up visits
Agree to have blood stored for possible future biomarker analysis
Exclusion Criteria
Received treatment with an investigational drug within the last 30 days
Receiving, or has received, any other radiation or systemic anticancer treatment for lymphoma
Pregnant or breastfeeding
Have known central nervous system (CNS) involvement
Have any significant concomitant disorder, including active bacterial, fungal, or viral infection, incompatible with participation in the study
Have a second primary malignancy (except adequately treated non-melanoma skin cancer)- Patients who have had another malignancy in the past, but have been disease-free for more than 5 years, are eligible
Unable to discontinue use of a concomitant medication that is a strong inducer or inhibitor of CYP3A4
Have a history of severe allergic or anaphylactic reaction to monoclonal antibody therapy
Confirmed diagnosis of progressive multifocal leukoencephalopathy
Have any of the following cardiac disorders: uncontrolled hypertension, unstable angina, myocardial infarction within 8 weeks of Day1, NYHA Grade 2 or higher congestive heart failure, ventricular arrhythmia requiring medication within 1 year of Day 1, NYHA Grade 2 or higher peripheral vascular disease
Received a live vaccine within 28 days of study Day 1
HIV positive
Have evidence of chronic hepatitis C infection as indicated by antibody to HCV with positive HCV-RNA
Have evidence of chronic hepatitis B infection as indicated by either: 1. HBsAg+ or 2. HBcAb+ with HBV-DNA+


Additional Information:
Participants will not be paid for their participation.

Updated on 09 Mar 2024. Study ID: 1805400146 (DB102-02)

Connect with a study center near you

What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center