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

Running, not enrolling · Phase 1

Conditions studied: Acute Myeloid Leukemias

In brief

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.

Key facts

Study ID

NCT06226571

Run by

Syndax Pharmaceuticals

People needed

76

Starts

2024-05-21

Expected to finish

2027-02-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Established, pathologically confirmed diagnosis of AML by World Health Organization 2022 criteria.
• Previously untreated AML and eligible to receive intensive chemotherapy.
• KMT2Ar, NPM1c, or NUP98r mutations identified by local laboratory prior to the first dose of SNDX-5613.
• Eastern Cooperative Oncology Group performance status ≤2 and ≤1 if >65 years old .
• Adequate liver, kidney, and cardiac function.

You may not qualify if…

• Diagnosis of acute promyelocytic leukemia.
• Clinically active central nervous system leukemia (blasts detected in cerebrospinal fluid, radiographic or clinical signs and symptoms).
• Fridericia's corrected QT interval (QTcF) >450 milliseconds (average of triplicate), diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
• Any gastrointestinal issue of the upper gastrointestinal tract that might affect oral drug absorption or ingestion.
• Cirrhosis with a Child-Pugh score of B or C.
• Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.
• Hepatitis B, Hepatitis C, or HIV-positive with detectable viral load.
• Documented active, uncontrolled infection.
• Uncontrolled disseminated intravascular coagulation.
• Lactating/breast feeding or pregnant.
• Use of prohibited concomitant chemotherapy, radiation therapy, or immunotherapy.
• Use of strong CYP3A4 inducers or inhibitors (except for Itraconazole, Ketoconazole, Posaconazole, or Voriconazole).

Where it is running

• City of Hope — Goodyear, Arizona, United States
• UCLA Medical Hematology — Burbank, California, United States
• City of Hope Medical Center — Duarte, California, United States
• AdventHealth Blood & Marrow Transplant Center — Orlando, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory Winship Cancer Institute — Atlanta, Georgia, United States
• University of Illinois — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• University of Louisville Health Brown Cancer Center — Louisville, Kentucky, United States
• Norton Cancer Institute, St. Matthews Campus — Louisville, Kentucky, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Allina Health Cancer Institute — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Institution name: Northwell Health-Brany — Lake Success, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• East Carolina University — Greenville, North Carolina, United States
• Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Oregon Health and Science University- Center for Hematologic Malignancies — Portland, Oregon, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• MUSC Hollings Cancer Center (HCC) — Charleston, South Carolina, United States
• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.