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 Sep 6, 2026, 3:41 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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".

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

Conditions

Acute Myeloid Leukemia (AML)

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

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: Aug 19, 2026

2025 – 2031

United States locations

U.S. sites: 42
U.S. states: 23
U.S. cities: 38

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, Los Angeles	Los Angeles	California	90095	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 Iowa	Iowa City	Iowa	52246	Recruiting
University of Kentucky	Lexington	Kentucky	40536	Recruiting
University of Massachusetts	Worcester	Massachusetts	01605	Recruiting
University of Michigan	Ann Arbor	Michigan	48109	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
State University of New York at Buffalo	Buffalo	New York	14263	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	10003	Recruiting
Columbia University	New York	New York	10032	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 Vermont Medical Center	Burlington	Vermont	05401	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
University of Wisconsin	Madison	Wisconsin	53792	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 73 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 Aug 19, 2026 · Synced Sep 6, 2026

Open the official record

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

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