OncoMatch/Clinical Trials/NCT06226571
A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias
Is NCT06226571 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including SNDX-5613 and Chemotherapy Regimen for acute myeloid leukemias.
Treatment: SNDX-5613 · Chemotherapy Regimen · HiDAC — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: KMT2A (MLL) rearrangement
KMT2Ar...mutations identified by local laboratory prior to the first dose of SNDX-5613
Required: NPM1 mutation
NPM1c...mutations identified by local laboratory prior to the first dose of SNDX-5613
Required: NUP98 rearrangement
NUP98r mutations identified by local laboratory prior to the first dose of SNDX-5613
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Kidney function
Adequate kidney function
Liver function
Adequate liver function; cirrhosis with a Child-Pugh score of B or C [excluded]
Cardiac function
Adequate cardiac function; 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 [excluded]; myocardial infarction, uncontrolled/unstable angina, congestive heart failure (NYHA Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack within 6 months prior to study entry [excluded]
Adequate liver, kidney, and cardiac function. Cirrhosis with a Child-Pugh score of B or C [excluded]. 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 [excluded]. 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA Medical Hematology · Burbank, California
- City of Hope Medical Center · Duarte, California
- AdventHealth Blood & Marrow Transplant Center · Orlando, Florida
- Tampa General Hospital · Tampa, Florida
- Emory Winship Cancer Institute · Atlanta, Georgia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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