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Active, not recruiting Phase 1 Interventional

A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

ClinicalTrials.gov ID: NCT06226571

Public ClinicalTrials.gov record NCT06226571. 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.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 5:43 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 1, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes

Brief summary

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

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes.

Study identification

NCT ID
NCT06226571
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Syndax Pharmaceuticals
Industry
Enrollment
76 participants

Conditions and interventions

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
May 20, 2024
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027
Last update posted
Jun 29, 2026

2024 – 2027

United States locations

U.S. sites
28
U.S. states
19
U.S. cities
26
Facility City State ZIP Site status
City of Hope Goodyear Arizona 85338
UCLA Medical Hematology Burbank California 91505
City of Hope Medical Center Duarte California 91010
AdventHealth Blood & Marrow Transplant Center Orlando Florida 32804
Tampa General Hospital Tampa Florida 33606
Emory Winship Cancer Institute Atlanta Georgia 30322
University of Illinois Chicago Illinois 60612
University of Chicago Chicago Illinois 60637
University of Louisville Health Brown Cancer Center Louisville Kentucky 40202
Norton Cancer Institute, St. Matthews Campus Louisville Kentucky 40207
Beth Israel Deaconess Medical Center Boston Massachusetts 02215
University of Michigan Ann Arbor Michigan 48109
Allina Health Cancer Institute Minneapolis Minnesota 55407
Washington University School of Medicine St Louis Missouri 63110
Institution name: Northwell Health-Brany Lake Success New York 11042
Memorial Sloan Kettering Cancer Center New York New York 10065
University of Rochester Medical Center Rochester New York 14642
SUNY Upstate Medical University Syracuse New York 13210
East Carolina University Greenville North Carolina 27834
Atrium Health Wake Forest Baptist Medical Center Winston-Salem North Carolina 27157
Cleveland Clinic Foundation Cleveland Ohio 44195
Oregon Health and Science University- Center for Hematologic Malignancies Portland Oregon 97239
UPMC Hillman Cancer Center Pittsburgh Pennsylvania 15232
MUSC Hollings Cancer Center (HCC) Charleston South Carolina 29425
Baylor University Medical Center Dallas Texas 75246
The University of Texas, MD Anderson Cancer Center Houston Texas 77030
LDS Hospital - Intermountain Healthcare Salt Lake City Utah 84143
West Virginia University Morgantown West Virginia 26506

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 20 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06226571, 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 Jun 29, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06226571 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →