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 (Jun 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
Treatments studied
Other
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)
Demographics
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 →Frequently asked questions
Is NCT06226571 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require KMT2A?
Yes, KMT2A rearrangement is a required biomarker for enrollment.
Does this trial require NPM1?
Yes, NPM1 mutation is a required biomarker for enrollment.
Does this trial require NUP98?
Yes, NUP98 rearrangement is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify