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NCT03263026 · ClinicalTrials.gov registry record · Phase 3
Study to Assess Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™
A Phase 3 study, sponsored by Denovo Biopharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 256
- Enrollment target
NCT03263026: Completed Phase 3 study, sponsored by Denovo Biopharma.
NCT03263026 is a Phase 3 study that has completed, run by Denovo Biopharma. The registered enrollment target is 256 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03263026, a Phase 3 study, has completed, sponsored by Denovo Biopharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 256 participants
- Enrollment target
Study 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.
Primary Outcome
The primary objective of this study is to compare the effect of R-CHOP/enzastaurin versus R-CHOP alone on overall survival in treatment naive, high-risk subjects with DLBCL who possess the DGM1™ biomarker.
Interventions
- DRUG Enzastaurin Hydrochloride
- OTHER R-CHOP + placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2018-03-20 |
| Est. Completion | 2022-08-11 |
| Phase | Phase 3 |
What the finished NCT03263026 record still lists
NCT03263026 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Enzastaurin Hydrochloride is the first listed.
NCT03263026 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03263026 about?
NCT03263026 is a clinical study titled "Study to Assess Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™". 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...
What is the current status of trial NCT03263026?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 256 participants. The study started on 2018-03-20. Estimated completion is 2022-08-11.
What interventions are being tested in trial NCT03263026?
The interventions under investigation include: Enzastaurin Hydrochloride (DRUG), R-CHOP + placebo (OTHER).
Who is sponsoring clinical trial NCT03263026?
This trial is sponsored by Denovo Biopharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03263026's enrollment target sits among peer trials
256 1240th of 2000 higher than 759 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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