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Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Sponsor: Kura Oncology, Inc.
Summary
The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.
Official title: Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
171
Start Date
2024-02-22
Completion Date
2027-08
Last Updated
2025-12-03
Healthy Volunteers
No
Conditions
Interventions
Ziftomenib
Oral administration
Fludarabine
Intravenous infusion
Idarubicin
Intravenous infusion
Cytarabine
Intravenous Infusion
Gilteritinib
Oral administration
Granulocyte colony-stimulating factor
Subcutaneous injection
Locations (44)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Health - Bowyer Oncology Center
Los Angeles, California, United States
UC Irvine Health Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California San Francisco
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States
Emory Healthcare - The Emory Clinic
Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Simmons Cancer Institute
Springfield, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
The University of Kansas Cancer Center
Kansas City, Kansas, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Cancer Institute
Detroit, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Northwell Health, LLC PRIME
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College-NY Presbyterian Hospital
New York, New York, United States
Wilmot Cancer Institute, University of Rochester
Rochester, New York, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
Atrium Health Levine Cancer Center
Charlotte, North Carolina, United States
UH Seidman Cancer Center
Cleveland, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Lehigh Valley Topper Cancer Institute
Allentown, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Vermont
Burlington, Vermont, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States
University of Washington
Seattle, Washington, United States
Froedtert & Medical College Clinics
Milwaukee, Wisconsin, United States
IRCCS Azienda Ospedaliero-Universitaria do Bologna - Policlinico di Sant'Orsola
Bologna, Italy
Ospedale Santa Maria delle Croci
Ravenna, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitari y Politecnic La Fe
Valencia, Spain