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NCT03268954 · ClinicalTrials.gov registry record · Phase 3
Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 454
- Enrollment target
NCT03268954 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 454 participants.
The verdict
NCT03268954, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 454 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML).
Interventions
- DRUG Azacitidine
- DRUG Pevonedistat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 454 participants |
| Start Date | 2017-11-28 |
| Est. Completion | 2024-10-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03268954
The ClinicalTrials.gov registry entry for NCT03268954 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 454 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Azacitidine is the first listed.
NCT03268954 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03268954 about?
NCT03268954 is a clinical study titled "Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)". The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is de...
What is the current status of trial NCT03268954?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 454 participants. The study started on 2017-11-28. Estimated completion is 2024-10-14.
What interventions are being tested in trial NCT03268954?
The interventions under investigation include: Azacitidine (DRUG), Pevonedistat (DRUG).
Who is sponsoring clinical trial NCT03268954?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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