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NCT04266795 · ClinicalTrials.gov registry record · Phase 2
A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy
A Phase 2 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 164
- Enrollment target
NCT04266795: Completed Phase 2 study, sponsored by Takeda.
NCT04266795 is a Phase 2 study that has completed, run by Takeda. The registered enrollment target is 164 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04266795, a Phase 2 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 164 participants
- Enrollment target
Study Summary
The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy. Participants will receive either pevonedistat + venetoclax + azacitidine or venetoclax + azacitidine in 28-day treatment cycles. Bone marrow samples (biopsy) will be collected throughout the study. Pevonedistat will be given as an intravenous (IV) infusion and Azacitidine will be given through IV or subcutaneous (under the skin). Study treatments may continue as long as the participant is receiving benefit from it. Participants may choose to stop treatment at any time.
Primary Outcome
EFS was defined as time from study randomization to date of failure to achieve complete remission (CR)/CR with incomplete blood count recovery (CRi), relapse from CR/CRi, or death. Assessments of disease response based on criteria: European Leukemia Net (ELN) 2017 guidelines. CR was defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC)≥1.0×10\^9/L (1000/µL); platelet count≥100×10\^9/L (100,0
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Pevonedistat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2020-10-13 |
| Est. Completion | 2025-10-06 |
| Phase | Phase 2 |
What the finished NCT04266795 record still lists
NCT04266795 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT04266795 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04266795 about?
NCT04266795 is a clinical study titled "A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy". The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy. Participants will receive either pevonedistat + venetoclax + azacitidine or vene...
What is the current status of trial NCT04266795?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2020-10-13. Estimated completion is 2025-10-06.
What interventions are being tested in trial NCT04266795?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Pevonedistat (DRUG).
Who is sponsoring clinical trial NCT04266795?
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 NCT04266795's enrollment target sits among peer trials
164 413th of 2000 higher than 1,583 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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