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Study identifier: NCT07007312 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Acute Myeloid Leukemia (AML)  ·  Sponsor: Kura Oncology, Inc.

PhasePhase 3
Planned participants1300
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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".

This description comes directly from the study's public registry record.

Talk to the study team

Kura Medical Information  ·  844-KURAONC (844-587-2662)  ·  medinfo@kuraoncology.com

Always discuss trial participation with your own doctor first.

Locations (106)

Banner MD Anderson Cancer CenterGilbert, Arizona, United StatesRecruiting
University of California, FresnoClovis, California, United StatesRecruiting
University of California, San DiegoLa Jolla, California, United StatesRecruiting
Cedars-Sinai Medical CenterLos Angeles, California, United StatesRecruiting
University of California, Los AngelesLos Angeles, California, United StatesRecruiting
University of California, IrvineOrange, California, United StatesRecruiting
University of ColoradoAurora, Colorado, United StatesRecruiting
Colorado Blood Cancer InstituteDenver, Colorado, United StatesRecruiting
Hartford HealthCare Cancer InstituteHartford, Connecticut, United StatesRecruiting
Yale University School of MedicineNew Haven, Connecticut, United StatesRecruiting
University of MiamiMiami, Florida, United StatesRecruiting
Moffitt Cancer Center & Research InstituteTampa, Florida, United StatesRecruiting

+ 94 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07007312