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

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

Trial Details

NCT ID

NCT07007312

Phase

PHASE3

Sponsor

Kura Oncology, Inc.

Status

RECRUITING

Cancer Type

Leukemia

Interventions

Ziftomenib
Placebo
Venetoclax
Azacitidine (AZA)
Daunorubicin
Cytarabine (Ara-C)

Locations (sample)

Gilbert, Arizona, United States|33.35283,-111.78903
Clovis, California, United States|36.82523,-119.70292
La Jolla, California, United States|32.84727,-117.2742
Los Angeles, California, United States|34.05223,-118.24368
Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

The following criteria apply to both the Nonintensive Therapy Study and the Intensive Therapy Study unless otherwise noted:
Age ≥18 years at time of signing the informed consent form.
Diagnosis of AML per the 2022 WHO Classification of Hematolymphoid Tumors (5th Edition).
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

For full eligibility, visit ClinicalTrials.gov.

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