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Evaluating SNDX-5613 with chemotherapy for acute myeloid leukemia

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

Phase 1 Interventional Syndax Pharmaceuticals · NCT06226571

This study is testing a new drug called SNDX-5613 combined with chemotherapy to see if it helps people with newly diagnosed acute myeloid leukemia who have certain genetic changes.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment76 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorSyndax Pharmaceuticals Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations46 sites (Burbank, California and 45 other locations)
Trial IDNCT06226571 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, pharmacokinetics, and clinical activity of SNDX-5613 when combined with intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia (AML) that have specific genetic alterations. It includes a Dose Escalation phase to determine the maximum tolerated dose and a Dose Expansion phase to explore safety and preliminary efficacy at tolerated dose levels. The treatment consists of an induction phase, a consolidation phase, and a maintenance phase with SNDX-5613, all within a structured 28-day cycle.

Who should consider this trial

Good fit: Ideal candidates are adults with newly diagnosed acute myeloid leukemia harboring KMT2A, NPM1, or NUP98 gene alterations who are eligible for intensive chemotherapy.

Not a fit: Patients with acute promyelocytic leukemia or those with clinically active central nervous system leukemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with specific genetic mutations associated with acute myeloid leukemia.

How similar studies have performed: While this approach is novel in its specific combination, similar studies targeting genetic mutations in AML have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Burbank, California and 45 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid LeukemiasSNDX-5613Lysine-specific Methyltransferase 2AKMT2A/MLLNucleophosmin 1NPM1Nucleoporin 98NUP98
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.