Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene

ClinicalTrials.gov ID: NCT05886049

Public ClinicalTrials.gov record NCT05886049. 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 May 18, 2026, 10:09 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

A Phase 1b Study of Menin Inhibitor SNDX-5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype or MLL/KMT2A Rearranged Disease.

Study identification

NCT ID: NCT05886049
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: National Cancer Institute (NCI); NIH
Enrollment: 28 participants

Conditions and interventions

Conditions

Interventions

Biospecimen Collection Procedure
Bone Marrow Aspiration Procedure
Bone Marrow Biopsy Procedure
Cytarabine Drug
Daunorubicin Drug
Multigated Acquisition Scan Procedure
Revumenib Drug
Transthoracic Echocardiography Test Procedure

Procedure · Drug

Eligibility (public fields only)

Age range: 18 Years to 75 Years
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: Jun 19, 2024
Primary completion: Dec 30, 2027
Completion: Dec 30, 2027
Last update posted: May 12, 2026

2024 – 2027

United States locations

U.S. sites: 22
U.S. states: 10
U.S. cities: 22

Facility	City	State	ZIP	Site status
UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California	92868	Recruiting
University of California Davis Comprehensive Cancer Center	Sacramento	California	95817	Suspended
UM Sylvester Comprehensive Cancer Center at Aventura	Aventura	Florida	33180	Recruiting
UM Sylvester Comprehensive Cancer Center at Coral Gables	Coral Gables	Florida	33146	Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach	Deerfield Beach	Florida	33442	Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida	33136	Recruiting
UM Sylvester Comprehensive Cancer Center at Plantation	Plantation	Florida	33324	Recruiting
University of Chicago Comprehensive Cancer Center	Chicago	Illinois	60637	Recruiting
University of Kansas Clinical Research Center	Fairway	Kansas	66205	Recruiting
University of Kansas Cancer Center	Kansas City	Kansas	66160	Recruiting
University of Kansas Hospital-Indian Creek Campus	Overland Park	Kansas	66211	Recruiting
University of Kansas Hospital-Westwood Cancer Center	Westwood	Kansas	66205	Recruiting
University of Maryland/Greenebaum Cancer Center	Baltimore	Maryland	21201	Recruiting
UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	27599	Recruiting
Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina	28203	Recruiting
Wake Forest University Health Sciences	Winston-Salem	North Carolina	27157	Recruiting
University of Cincinnati Cancer Center-UC Medical Center	Cincinnati	Ohio	45219	Recruiting
Ohio State University Comprehensive Cancer Center	Columbus	Ohio	43210	Recruiting
University of Cincinnati Cancer Center-West Chester	West Chester	Ohio	45069	Recruiting
University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	73104	Recruiting
Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah	84112	Recruiting
University of Virginia Cancer Center	Charlottesville	Virginia	22908	Recruiting

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

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05886049, 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 May 12, 2026 · Synced May 18, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05886049 live on ClinicalTrials.gov.

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