A Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
Syndax Pharmaceuticals
Study ID
NCT06226571
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Acute Myeloid Leukemias

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Revumenib — DRUG
    Participants will receive revumenib orally during Induction, Consolidation, and Maintenance until meeting criteria for discontinuation.
  • Chemotherapy Regimen — DRUG
    Induction: Participants will receive an intravenous (IV), 2-drug combination of cytarabine and either daunorubicin or idarubicin.
  • HiDAC — DRUG
    Consolidation: Participants will receive HiDAC IV.

Study Details

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of revumenib in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes.

Key Dates

First listed
Jan 26, 2024
Start date
May 21, 2024
Status verified
Sep 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
96 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Revumenib
    Dose Escalation: * Induction: Sequential cohorts of escalating dose levels of revumenib with chemotherapy regimen. * Consolidation: Cohorts will receive high-dose cytarabine (HiDAC) chemotherapy followed by revumenib. * Maintenance Monotherapy: Cohorts will receive revumenib Dose Expansion: * Induction: revumenib at tolerated dose level with chemotherapy regimen. * Consolidation: Cohorts will receive revumenib with chemotherapy regimen and HiDAC. * Maintenance Monotherapy: Cohorts will receive revumenib.

Primary Outcome Measure

Dose Escalation: Number of Participants with Dose-limiting Toxicities [ Time Frame: Up to Day 42 ]

Locations (28)

FacilityCityStateZIPSite coordinators
City of HopeGoodyearArizona85338-
UCLA Medical HematologyBurbankCalifornia91505-
City of Hope Medical CenterDuarteCalifornia91010-
AdventHealth Blood & Marrow Transplant CenterOrlandoFlorida32804-
Tampa General HospitalTampaFlorida33606-
Emory Winship Cancer InstituteAtlantaGeorgia30322-
University of ChicagoChicagoIllinois60637-
University of IllinoisChicagoIllinois60612-
Norton Cancer Institute, St. Matthews CampusLouisvilleKentucky40207-
University of Louisville Health Brown Cancer CenterLouisvilleKentucky40202-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
University of MichiganAnn ArborMichigan48109-
Allina Health Cancer InstituteMinneapolisMinnesota55407-
Washington University School of MedicineSt LouisMissouri63110-
Institution name: Northwell Health-BranyLake SuccessNew York11042-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of Rochester Medical CenterRochesterNew York14642-
SUNY Upstate Medical UniversitySyracuseNew York13210-
East Carolina UniversityGreenvilleNorth Carolina27834-
Atrium Health Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
Cleveland Clinic FoundationClevelandOhio44195-
Oregon Health and Science University- Center for Hematologic MalignanciesPortlandOregon97239-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
MUSC Hollings Cancer Center (HCC)CharlestonSouth Carolina29425-
Baylor University Medical CenterDallasTexas75246-
The University of Texas, MD Anderson Cancer CenterHoustonTexas77030-
LDS Hospital - Intermountain HealthcareSalt Lake CityUtah84143-
West Virginia UniversityMorgantownWest Virginia26506-

Find similar trials in Goodyear, AZ

By research site
City of Hope· Goodyear, AZUCLA Medical Hematology· Burbank, CACity of Hope Medical Center· Duarte, CAAdventHealth Blood & Marrow Transplant Center· Orlando, FLTampa General Hospital· Tampa, FLEmory Winship Cancer Institute· Atlanta, GA

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