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

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 ID
NCT07211958
Phase
PHASE3
Sponsor
Syndax Pharmaceuticals
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Revumenib
  • Placebo
  • Intensive Chemotherapy Regimen
Locations (sample)
  • Goodyear, Arizona, United States|33.43532,-112.35821
  • Duarte, California, United States|34.13945,-117.97729
  • Farmington, Connecticut, United States|41.71982,-72.83204
  • Tampa, Florida, United States|27.94752,-82.45843
  • Indianapolis, Indiana, United States|39.76838,-86.15804

Key Eligibility Criteria

  • Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy.
  • Presence of an NPM1 mutation.
  • Eastern Cooperative Oncology Group performance status ≤2 (≤1 if \>65 years old); Karnofsky or Lansky ≥40.
  • Have a life expectancy of ≥3 months as judged by the Investigator.

For full eligibility, visit ClinicalTrials.gov.

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