A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

Part of paid clinical trials in Burbank, California.

Sponsor
Syndax Pharmaceuticals
Study ID
NCT06226571
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Acute Myeloid Leukemias

Eligibility Criteria

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

Interventions

  • SNDX-5613 — DRUG
    Participants will receive SNDX-5613 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 SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes.

Key Dates

Start date
May 21, 2024
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
76 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SNDX-5613
    Dose Escalation: * Induction: Sequential cohorts of escalating dose levels of SNDX-5613 with chemotherapy regimen. * Consolidation: Cohorts will receive high-dose cytarabine (HiDAC) chemotherapy followed by SNDX-5613. * Maintenance Monotherapy: Cohorts will receive SNDX-5613. Dose Expansion: * Induction: SNDX-5613 at tolerated dose level with chemotherapy regimen. * Consolidation: Cohorts will receive SNDX-5613 with chemotherapy regimen and HiDAC. * Maintenance Monotherapy: Cohorts will receive SNDX-5613.

Primary Outcome Measure

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

Central Contacts

Locations (26)

FacilityCityStateZIPSite coordinators
UCLA Medical HematologyBurbankCalifornia91505
Gary Schiller, MD
[email protected]
City of Hope Medical CenterDuarteCalifornia91010
Wirlen Elame
[email protected]
626-218-7451
Ibrahim Aldoss, M.D. (PRINCIPAL_INVESTIGATOR)
AdventHealth Blood & Marrow Transplant CenterOrlandoFlorida32804
Brian Parkin, MD
[email protected]
Tampa General HospitalTampaFlorida33606
David Swoboda, MD
[email protected]
Emory Winship Cancer InstituteAtlantaGeorgia30322
William Blum, MD
[email protected]
University of ChicagoChicagoIllinois60637
Michael Thirman, MD
[email protected]
Norton Cancer Institute, St. Matthews CampusLouisvilleKentucky40207
Don Stevens, MD
[email protected]
University of Louisville Health Brown Cancer CenterLouisvilleKentucky40202
Mohamed Hegazi, MD
[email protected]
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Margaret Michaelian
[email protected]
University of MichiganAnn ArborMichigan48109
Dale Bixby, MD
[email protected]
Allina Health Cancer InstituteMinneapolisMinnesota55407
Fiona He, MD
[email protected]
Washington University School of MedicineSt LouisMissouri63110
Dr. John DiPersio
[email protected]
Institution name: Northwell Health-BranyLake SuccessNew York11042
David Chitty, MD
[email protected]
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Eytan Stein, MD
[email protected]
University of Rochester Medical CenterRochesterNew York14642
Jozal Moore, MD
[email protected]
SUNY Upstate Medical UniversitySyracuseNew York13210
Teresa Gentile, MD
[email protected]
East Carolina UniversityGreenvilleNorth Carolina27834
Darla Liles, MD
[email protected]
Atrium Health Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157
Timoth Pardee, MD
[email protected]
Cleveland Clinic FoundationClevelandOhio44195
Moaath Mustafa Ali, MD, MPH
[email protected]
Oregon Health and Science University- Center for Hematologic MalignanciesPortlandOregon97239
Elie Traer, MD
[email protected]
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Annie lm, MD
[email protected]
MUSC Hollings Cancer Center (HCC)CharlestonSouth Carolina29425
Praneeth Baratam, MD
[email protected]
Baylor University Medical CenterDallasTexas75246
Bradley Christensen, MD
[email protected]
The University of Texas, MD Anderson Cancer CenterHoustonTexas77030
Ghayas C. Issa, MD
[email protected]
LDS Hospital - Intermountain HealthcareSalt Lake CityUtah84143
Bradley Hunter, MD
[email protected]
West Virginia UniversityMorgantownWest Virginia26506
Carl Shultz, MD
[email protected]

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