NCT07211958 Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
| NCT ID | NCT07211958 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Syndax Pharmaceuticals |
| Condition | Acute Myeloid Leukemias |
| Study Type | INTERVENTIONAL |
| Enrollment | 468 participants |
| Start Date | 2025-11-25 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 468 participants in total. It began in 2025-11-25 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Key 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07211958 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Acute Myeloid Leukemias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07211958 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 468 participants.
Is NCT07211958 currently recruiting?
Yes, NCT07211958 is actively recruiting participants. Contact the research team at clinicaltrials@syndax.com for enrollment information.
Where is the NCT07211958 trial being conducted?
This trial is being conducted at Melbourne, Australia, Gosford, Australia, Batumi, Georgia, Tbilisi, Georgia and 11 additional locations.
Who is sponsoring the NCT07211958 clinical trial?
NCT07211958 is sponsored by Syndax Pharmaceuticals. The trial plans to enroll 468 participants.
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