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A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias
Sponsor: Syndax Pharmaceuticals
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2024-05-21
Completion Date
2027-02
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
SNDX-5613
Participants will receive SNDX-5613 orally during Induction, Consolidation, and Maintenance until meeting criteria for discontinuation.
Chemotherapy Regimen
Induction: Participants will receive an intravenous (IV), 2-drug combination of cytarabine and either daunorubicin or idarubicin.
HiDAC
Consolidation: Participants will receive HiDAC IV.
Locations (46)
UCLA Medical Hematology
Burbank, California, United States
City of Hope Medical Center
Duarte, California, United States
AdventHealth Blood & Marrow Transplant Center
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Louisville Health Brown Cancer Center
Louisville, Kentucky, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Allina Health Cancer Institute
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Institution name: Northwell Health-Brany
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
East Carolina University
Greenville, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health and Science University- Center for Hematologic Malignancies
Portland, Oregon, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
MUSC Hollings Cancer Center (HCC)
Charleston, South Carolina, United States
Baylor University Medical Center
Dallas, Texas, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
LDS Hospital - Intermountain Healthcare
Salt Lake City, Utah, United States
West Virginia University
Morgantown, West Virginia, United States
Northern Hospital, Victoria
Epping, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Royal Adelaide Hospital
Adelaide, Australia
The Alfred Hospital, Victoria
Melbourne, Australia
Sir Charles Gairdner Hospital
Nedlands, Australia
University of Alberta Hospital
Edmonton, Alberta, Canada
Gordon and Leslie Diamond Health Care Center
Vancouver, British Columbia, Canada
The Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada
University Medical Center Utrecht
Utrecht, Netherlands
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital San Pedro de Alcantara
Cáceres, Spain
Hospital Universitario Virgen de Las Nieves
Granada, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario De Salamanca
Salamanca, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain
Universitat de Valencia
Valencia, Spain
Hammersmith Hospital
London, London, City of, United Kingdom
The Royal Marsden NHS
Sutton, United Kingdom