Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older/Unfit AML Patients (VENP-A-QUI)

Study acronym: VENP-A-QUI
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Study sites: 51 to 52
  2. Site details revised at 1 of 51 sites
  3. Site details revised at 1 of 51 sites
  4. Eligibility criteria expanded, about 25 words
    • Site details revised at 1 of 51 sites
    • Study description expanded, about 5 words
  5. Site details revised at 2 of 51 sitesv6
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  1. Site details revised at 1 of 51 sitesv5
  2. Site details revised at 2 of 51 sitesv4
  3. Site details revised at 3 of 51 sitesv3
  1. Recruitment opened
    • Start date changed from estimate of Mar 2026 to Jul 2, 2026
    • Site details revised at 51 of 51 sites
    v2
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if Venetoclax+Azacytidine+Quizartinib works better than standard therapy (Venetoclax+Azacytdine) to treat naïve adult patients with acute myeloid leukemia (AML) who are not suitable for standard induction therapy due to age, co-morbidities or other risk factors. The main question it aims to answer is: \- Does the combination of Venetoclax+Azacytidine+Quizartinib show more probability of overall survival than Venetoclax+Azacytdine? Researchers will compare Venetoclax+Azacytidine+Quizartinib to Venetoclax+Azacytdine to see if Venetoclax+Azacytidine+Quizartinib works better than Venetoclax+Azacytdine to treat AML. Participants will be randomized to one of the two treatment arms in a 1:1 ratio, both of which will have treatment cycles of 28 days.
Trial Details
NCT Number NCT07478991
Lead Sponsor PETHEMA Foundation
Conditions
(from sponsor)		 Acute Myeloid Leukemia, Adult
Related terms Leukemia, Myeloid, Acute
Enrollment 376 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov