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

468 patients around the world

Available in Brazil

Syndax Pharmaceuticals

468Patients around the world

This study is for people with

Leukemia

Acute myeloid leukemia

Requirements for the patient

From 12 Years

All Gender

Medical requirements

: 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.

: 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.

StudyREVEAL-ND NPM1

SponsorSyndax Pharmaceuticals

Study typeInterventional

Conditions

Acute myeloid leukemia

Requirements

From 12 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07211958