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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Revumenib + Intensive Chemotherapy 		Participants will receive revumenib plus an intensive chemotherapy regimen.
  • Drug: Revumenib
    Participants will receive revumenib orally.
    Other names:
    • SNDX-5613
  • Drug: Intensive Chemotherapy Regimen
    Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.
Placebo Comparator
Placebo + Intensive Chemotherapy 		Participants will receive placebo plus an intensive chemotherapy regimen.
  • Drug: Placebo
    Participants will receive placebo (non-active agent) orally.
  • Drug: Intensive Chemotherapy Regimen
    Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.

Recruiting Locations

Clinical Trial Site
Goodyear, Arizona 85338

Clinical Trial Site
Duarte, California 91010

Clinical Trial Site
Shreveport, Louisiana 71103

More Details

Status
Recruiting
Sponsor
Syndax Pharmaceuticals

Study Contact

Syndax Pharmaceuticals
781-419-1400
clinicaltrials@syndax.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.