Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation

Study acronym: REVEAL-ND NPM1
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 109 → 149 locations
    • Eligibility criteria expanded, about 14 words
  2. Trial sites expanded: 83 → 109 locationsv9
  3. Trial sites expanded: 52 → 83 locationsv8
  4. Trial sites expanded: 24 → 52 locationsv7
  5. Trial sites expanded: 14 → 24 locationsv6
  6. Trial sites expanded: 9 → 14 locations
    • Secondary endpoints: 8 to 9
    v5
  7. Study sites: 5 to 9v4
  8. Study sites: 2 to 5v3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Dec 2025 to Nov 25, 2025
    v2
  10. 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 purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.
Trial Details
NCT Number NCT07211958
Lead Sponsor Syndax Pharmaceuticals
Conditions
(from sponsor)		 Acute Myeloid Leukemias
Related terms Leukemia, Myeloid, Acute
Enrollment 468 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov