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

Sponsor
Syndax Pharmaceuticals
Study ID
NCT07211958
Phase
PHASE3
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemias

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Revumenib — DRUG
    Participants will receive revumenib orally.
  • Placebo — DRUG
    Participants will receive placebo (non-active agent) orally.
  • Intensive Chemotherapy Regimen — DRUG
    Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.

Study Details

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.

Key Dates

Start date
Nov 25, 2025
Status verified
May 2026
Primary completion
Jun 30, 2029
Completion
Jan 31, 2031

Study Design

Enrollment
468 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Revumenib + Intensive Chemotherapy
    Participants will receive revumenib plus an intensive chemotherapy regimen.
  • Placebo Comparator: Placebo + Intensive Chemotherapy
    Participants will receive placebo plus an intensive chemotherapy regimen.

Primary Outcome Measure

Event Free Survival [ Time Frame: Up to 2 years ]

Central Contacts

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