A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML)
NCT07581002 · REVIVAL Phase 2/3Recruiting
- Lead sponsor
- AbbVie (Industry)
- Enrollment
- 660 (estimated)
- Start date
- 30 Jun 2026
- Primary completion
- Jun 2032 (estimated)
- Study completion
- 1 Jun 2032
- Last update posted
- 22 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Sequential
- Masking
- Double
- Arms
- 4
Interventions
- Pivekimab Sunirine Drug
- Venetoclax Drug
- Azacitidine Drug
- Matching Placebo for PVEK Drug
Conditions and primary outcome
- Acute Myeloid Leukemia
Primary outcome
Phase 2: Complete remission (CR) (Up to Approximately 71 Months); Phase 3: Complete remission (CR) (Up to Approximately 71 Months); Phase 3: Overall Survival (OS) (Up to Approximately 71 Months); Number of Participants with Adverse Events (AEs) (Up to approximately 71 months)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT07581002.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT07581002 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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