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?

Investigating the Effect of an Investigational Medication with R-CHOP on Survival in High-Risk Diffuse Large B-Cell Lymphoma

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

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.

Detailed description of study

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.

Eligibility of study

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

  • Conditions: Diffuse Large B-Cell Lymphoma
  • Age: 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+

Updated on 19 Feb 2024. Study ID: 1805400146 (DB102-02)

This study investigates the effects of an investigational medication combined with R-CHOP treatment on overall survival in patients with high-risk Diffuse Large B-Cell Lymphoma (DLBCL) who have a specific biomarker called DGM1. DLBCL is a type of cancer that affects white blood cells. The study aims to see if adding the investigational medication to the standard R-CHOP treatment can improve survival outcomes for these patients.

Participants in this study will be randomly assigned to receive either the investigational medication with R-CHOP or a placebo with R-CHOP. They will undergo up to 6 cycles of treatment, with each cycle lasting 3 weeks. The response to the treatment will be evaluated using PET/CT scans. Those who respond well to the investigational medication may continue receiving it as maintenance therapy for up to 2 additional years.

  • Who can participate: Adults with CD20-positive Diffuse Large B-Cell Lymphoma who have not received prior treatment for lymphoma can participate if they have adequate organ function and are willing to use contraception. Participants should not have CNS involvement or significant health disorders that interfere with the study.
  • Study details: Participants will take part in a randomized study where they will either receive the investigational medication with R-CHOP or a placebo with R-CHOP. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. Participants must be able to swallow tablets and agree to follow-up visits.

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