Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
Not Applicable
Not yet recruiting
- Conditions
- Acute Myeloid Leukemias
- Interventions
- Registration Number
- NCT07211958
- Lead Sponsor
- Syndax Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 468
Inclusion 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.
- Negative serum pregnancy test.
- Adequate liver, kidney, and cardiac function.
Key
Exclusion Criteria
- Diagnosis of active acute promyelocytic leukemia.
- Active central nervous system disease.
- Fridericia's corrected QT interval (QTcF) >450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
- Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion.
- Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy).
- Inability to swallow oral medication.
- Pregnant or nursing females.
- Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load.
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Revumenib + Intensive Chemotherapy Revumenib Participants will receive revumenib plus an intensive chemotherapy regimen. Revumenib + Intensive Chemotherapy Intensive Chemotherapy Regimen Participants will receive revumenib plus an intensive chemotherapy regimen. Placebo + Intensive Chemotherapy Placebo Participants will receive placebo plus an intensive chemotherapy regimen. Placebo + Intensive Chemotherapy Intensive Chemotherapy Regimen Participants will receive placebo plus an intensive chemotherapy regimen.
- Primary Outcome Measures
Name Time Method Event Free Survival Up to 2 years Measurable Residual Disease Complete Remission Rate Up to 2 years
- Secondary Outcome Measures
Name Time Method Overall Survival Up to 5 years Rate of Complete Remission Up to 2 years Overall Response Rate Up to 2 years Duration of Complete Remission Up to 2 years Duration of Composite Complete Remission Up to 2 years Duration of Response Up to 2 years Number of Participants with a Treatment-emergent Adverse Event Up to 2 years Change from Baseline in Patient-reported Fatigue Questionnaire Scores Up to 2 years