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Study to Assess Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™

NCT03263026 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2025-01-23

Study results available
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Summary

This randomized, placebo-controlled phase 3 study planned to enroll approximately 235 treatment-naïve subjects with high-risk Diffuse Large B-Cell Lymphoma (DLBCL). Subjects were randomized 1:1 to R-CHOP plus enzastaurin or R-CHOP (plus placebo during induction). All subjects received up to 6 cycles (3 weeks per cycle) of treatment. PET/ CT was used to assess radiographic response at the end of treatment. Each subject's treatment assignment was unblinded after combination phase tumor response assessment. Subjects randomized to the enzastaurin arm who have a complete response (CR) or partial response (PR) (at investigator's discretion) by Lugano Classification had the opportunity to continue in the single-agent phase of the study and receive single-agent enzastaurin for up to 2 additional years.

Conditions

  • Diffuse Large B-Cell Lymphoma

Interventions

DRUG

Enzastaurin Hydrochloride

R-CHOP + Enzastaurin (Kinenza®) 125 mg

OTHER

R-CHOP + placebo

R-CHOP + placebo

Sponsors & Collaborators

  • Denovo Biopharma LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2022-08-11
Completion
2022-08-11
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03263026 on ClinicalTrials.gov