Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Acute Myeloid Leukemia (AML)

In brief

Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells. This protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo. In the second study, the Intensive Therapy Study, medically fit patients will receive (a) the SOC therapies cytarabine and daunorubicin, plus either ziftomenib or a placebo during a first treatment phase called induction, (b) cytarabine plus either ziftomenib or a placebo during a second treatment phase called consolidation, and (c) ziftomenib or a placebo during a third treatment phase called maintenance. The physician will determine which study is the appropriate treatment for the patient, but neither the patient nor their physician will know whether the patient has been assigned to receive ziftomenib or a placebo. This design is called "double-blinded".

Key facts

Study ID: NCT07007312
Run by: Kura Oncology, Inc.
People needed: 1300
Starts: 2025-09-26
Expected to finish: 2031-11-01
Last updated by the study team: 2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

University of California, Fresno — Clovis, California, United States (enrolling)
University of California, San Diego — La Jolla, California, United States (enrolling)
Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
University of California, Los Angeles — Los Angeles, California, United States (enrolling)
University of California, Irvine — Orange, California, United States (enrolling)
University of Colorado — Aurora, Colorado, United States (enrolling)
Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
Hartford HealthCare Cancer Institute — Hartford, Connecticut, United States (enrolling)
Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
University of Miami — Miami, Florida, United States (enrolling)
Moffitt Cancer Center & Research Institute — Tampa, Florida, United States (enrolling)
University of Iowa — Iowa City, Iowa, United States (enrolling)
University of Kentucky — Lexington, Kentucky, United States (enrolling)
University of Massachusetts — Worcester, Massachusetts, United States (enrolling)
University of Michigan — Ann Arbor, Michigan, United States (enrolling)
Wayne State University School of Medicine — Detroit, Michigan, United States (enrolling)
University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
Rutgers Biomedical and Health Sciences — New Brunswick, New Jersey, United States (enrolling)
University of New Mexico — Albuquerque, New Mexico, United States (enrolling)
State University of New York at Buffalo — Buffalo, New York, United States (enrolling)
Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
Columbia University — New York, New York, United States (enrolling)
Weill Cornell Medical Center — New York, New York, United States (enrolling)
University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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