A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes
Status: Recruiting
Location: See all (37) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Established, pathologically confirmed diagnosis of AML by World Health Organization 2022 criteria.
• Previously untreated AML and eligible to receive intensive chemotherapy.
• KMT2Ar, NPM1c, or NUP98r mutations identified by local laboratory prior to the first dose of SNDX-5613.
• Eastern Cooperative Oncology Group performance status ≤2 and ≤1 if \>65 years old .
• Adequate liver, kidney, and cardiac function.
Locations
United States
California
UCLA Medical Hematology
RECRUITING
Burbank
City of Hope Medical Center
RECRUITING
Duarte
Florida
AdventHealth Blood & Marrow Transplant Center
RECRUITING
Orlando
Tampa General Hospital
RECRUITING
Tampa
Georgia
Emory Winship Cancer Institute
RECRUITING
Atlanta
Illinois
University of Chicago
RECRUITING
Chicago
Kentucky
Norton Cancer Institute, St. Matthews Campus
RECRUITING
Louisville
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
Allina Health Cancer Institute
RECRUITING
Minneapolis
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Atrium Health Wake Forest Baptist Medical Center
RECRUITING
Winston-salem
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
SUNY Upstate Medical University
RECRUITING
Syracuse
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Oregon
Oregon Health and Science University- Center for Hematologic Malignancies
RECRUITING
Portland
Pennsylvania
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
South Carolina
MUSC Hollings Cancer Center (HCC)
RECRUITING
Charleston
Texas
Baylor University Medical Center
RECRUITING
Dallas
The University of Texas, MD Anderson Cancer Center
RECRUITING
Houston
Utah
LDS Hospital - Intermountain Healthcare
RECRUITING
Salt Lake City
West Virginia
West Virginia University
RECRUITING
Morgantown
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Northern Hospital, Victoria
RECRUITING
Epping
The Alfred Hospital, Victoria
RECRUITING
Melbourne
Sir Charles Gairdner Hospital
RECRUITING
Nedlands
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital San Pedro de Alcantara
RECRUITING
Cáceres
Hospital Universitario Virgen de Las Nieves
RECRUITING
Granada
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen del Rocio - PPDS
RECRUITING
Seville
Universitat de Valencia
RECRUITING
Valencia
United Kingdom
Hammersmith Hospital
RECRUITING
London
The Royal Marsden NHS
RECRUITING
Sutton
Contact Information
Primary
Syndax Pharmaceuticals
clinicaltrials@syndax.com
781-419-1400
Time Frame
Start Date: 2024-05-21
Estimated Completion Date: 2027-02
Participants
Target number of participants: 76
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Syndax Pharmaceuticals