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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07007312

Public ClinicalTrials.gov record NCT07007312. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Apr 22, 2026, 8:33 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia

Study identification

NCT ID
NCT07007312
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Kura Oncology, Inc.
Industry
Enrollment
1,300 participants

Conditions and interventions

Interventions

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

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 25, 2025
Primary completion
Oct 31, 2031
Completion
Oct 31, 2031
Last update posted
Apr 8, 2026

2025 – 2031

United States locations

U.S. sites
34
U.S. states
20
U.S. cities
32
Facility City State ZIP Site status
Banner MD Anderson Cancer Center Gilbert Arizona 85234 Recruiting
University of California, Fresno Clovis California 93611 Recruiting
University of California, San Diego La Jolla California 92093 Recruiting
Cedars-Sinai Medical Center Los Angeles California 90048 Recruiting
University of California, Irvine Orange California 92868 Recruiting
University of Colorado Aurora Colorado 80045 Recruiting
Colorado Blood Cancer Institute Denver Colorado 80218 Recruiting
Hartford HealthCare Cancer Institute Hartford Connecticut 06106 Recruiting
Yale University School of Medicine New Haven Connecticut 06510 Recruiting
University of Miami Miami Florida 33136 Recruiting
Moffitt Cancer Center & Research Institute Tampa Florida 33612 Recruiting
University of Kentucky Lexington Kentucky 40536 Recruiting
Wayne State University School of Medicine Detroit Michigan 48201 Recruiting
University of Minnesota Minneapolis Minnesota 55455 Recruiting
Rutgers Biomedical and Health Sciences New Brunswick New Jersey 08903 Recruiting
University of New Mexico Albuquerque New Mexico 87131 Recruiting
Icahn School of Medicine at Mount Sinai New York New York 10003 Recruiting
Weill Cornell Medical Center New York New York 10065 Recruiting
University of North Carolina, Chapel Hill Chapel Hill North Carolina 27514 Recruiting
Duke University Medical Center Durham North Carolina 27710 Recruiting
Ohio State University Columbus Ohio 43210 Recruiting
Willamette Valley Cancer Institute Eugene Oregon 97401 Recruiting
University of Pennsylvania Philadelphia Pennsylvania 19104 Recruiting
Baptist Clinical Research Institute Memphis Tennessee 38120 Recruiting
Tennessee Oncology Nashville Tennessee 37203 Recruiting
TriStar Centennial Medical Center Nashville Tennessee 37203 Recruiting
Texas Oncology-Austin Midtown Austin Texas 78705 Recruiting
Texas Oncology-Presbyterian Cancer Center Dallas Texas 75231 Recruiting
University of Texas Houston Texas 77030 Recruiting
Texas Oncology - San Antonio Medical Center San Antonio Texas 78240 Recruiting
University of Virginia School of Medicine Charlottesville Virginia 22903 Recruiting
Virginia Cancer Specialists Manassas Virginia 20110 Recruiting
WVU Medicine Wheeling Hospital Wheeling West Virginia 26003 Recruiting
Froedtert & Medical College of Wisconsin Milwaukee Wisconsin 53226 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07007312, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 8, 2026 · Synced Apr 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07007312 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →