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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: Completed Phase 3 study, sponsored by Takeda.
NCT03268954 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 454 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
EFS was defined as the time from randomization to the date of an EFS event. An EFS event was defined as death or transformation to acute myelogenous leukemia (AML) (World Health Organization \[WHO\] classification as a participant having greater than 20 % blasts in the blood or marrow and an increase of blast count by 50%), whichever event occurred first, in participants with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemias (CMML). An EFS event was defined as death in particip
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 |
What the finished NCT03268954 record still lists
NCT03268954 is an interventional study that assigns participants to a tested intervention. The registered 454 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 (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Azacitidine is the first listed.
NCT03268954 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03268954's enrollment target sits among peer trials
454 831st of 2000 higher than 1,167 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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