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

Recruiting Phase 3 Interventional Study
Acute Myeloid Leukemias
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
468 (estimated)
Sponsor
Syndax Pharmaceuticals · Industry
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About This Trial

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 Locations
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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 expec…
Contacts

Syndax Pharmaceuticals

781-419-1400

clinicaltrials@syndax.com

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