Study on Revumenib with Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia (AML) with NPM1 Mutation

Sponsor: Syndax Pharmaceuticals

Sponsor score: 60

ClinicalTrials ID:NCT07211958

This clinical trial is testing whether adding the drug revumenib to standard chemotherapy can improve treatment outcomes for patients with newly diagnosed Acute Myeloid Leukemia (AML) that has a specific genetic mutation. The study will also evaluate the safety of this combination treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if combining revumenib with standard chemotherapy can lead to better results for patients with Acute Myeloid Leukemia (AML) who have a specific genetic mutation called NPM1. Researchers will also check if adding revumenib to chemotherapy is safe for patients.

Eligibility Criteria

Inclusion Criteria

  • Must have been newly diagnosed with AML and not yet treated, and be eligible for intensive chemotherapy.
  • Must have a specific genetic mutation known as NPM1.
  • Must have a performance status score of 2 or less, or 1 or less if over 65 years old, indicating good overall health.
  • Must have a life expectancy of at least 3 months, as determined by the study doctor.
  • Must have a negative pregnancy test if applicable.
  • Must have adequate liver, kidney, and heart function.

Exclusion Criteria

  • Cannot have a diagnosis of active acute promyelocytic leukemia.
  • Cannot have active disease affecting the central nervous system.
  • Cannot have a heart condition that affects the QT interval on an ECG, or a family history of Long QT syndrome.
  • Cannot have gastrointestinal issues that affect the ability to take oral medication.
  • Cannot have another active cancer that requires treatment, except for stable breast or prostate cancer on hormone therapy.
  • Cannot be unable to swallow pills.
  • Cannot be pregnant or breastfeeding.
  • Cannot have active or chronic hepatitis B, active hepatitis C, or HIV with a detectable viral load.

Locations

FACILITYZIPCITYSTATE
Clinical Trial Site85338GoodyearArizona
Clinical Trial Site91010DuarteCalifornia
Clinical Trial Site46237IndianapolisIndiana
Clinical Trial Site71103ShreveportLouisiana
Clinical Trial Site02903ProvidenceRhode Island
Clinical Trial Site77030HoustonTexas

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