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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 is a Phase 3 study that has completed, run by Denovo Biopharma. The registered enrollment target is 256 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03263026
The ClinicalTrials.gov registry entry for NCT03263026 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Denovo Biopharma, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Enzastaurin Hydrochloride is the first listed.
NCT03263026 reports 0 study locations.
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.
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