A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML
Recruiting now · Phase 1
Conditions studied: Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation, Refractory AML, AML With Mutated NPM1, Acute Myeloid Leukemia Recurrent, Acute Myeloid Leukemia, in Relapse, NPM1 Mutation, KMT2Ar, Myeloid Sarcoma, Nucleophosmin 1-mutated Acute Myeloid Leukemia
In brief
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations. This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion. The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.
Key facts
- Study ID
- NCT05735184
- Run by
- Kura Oncology, Inc.
- People needed
- 420
- Starts
- 2023-07-18
- Expected to finish
- 2030-04-01
- Last updated by the study team
- 2026-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic - Phoenix — Phoenix, Arizona, United States (enrolling)
- Moores UC San Diego Cancer Center — La Jolla, California, United States (enrolling)
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
- UCLA - Bowyer Oncology Center — Los Angeles, California, United States (enrolling)
- UC Irvine Health Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)
- University of Colorado — Aurora, Colorado, United States (enrolling)
- Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
- Yale Cancer Center and Smilow Cancer Hospital — New Haven, Connecticut, United States (enrolling)
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)
- Emory Healthcare - The Emory Clinic — Atlanta, Georgia, United States (enrolling)
- Georgia Cancer Center at Augusta University — Augusta, Georgia, United States (enrolling)
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States (enrolling)
- Loyola University Medical Center — Maywood, Illinois, United States (enrolling)
- University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States (enrolling)
- The University of Kansas Medical Center Research Institute — Fairway, Kansas, United States (enrolling)
- University of Kentucky Markey Cancer Center — Louisville, Kentucky, United States (enrolling)
- Norton Cancer Institute - St. Matthews — Louisville, Kentucky, United States (enrolling)
- Ochsner MD Anderson Cancer Center — Jefferson, Louisiana, United States (enrolling)
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- UMass Chan Medical School — Worcester, Massachusetts, United States (enrolling)
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States (enrolling)
- Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
- University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
- Mayo Clinic - Rochester — Rochester, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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