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Study of SNDX-5613 with Chemotherapy for Acute Myeloid Leukemia

This study is testing a new drug, SNDX-5613, in combination with standard intensive chemotherapy for people with newly diagnosed acute myeloid leukemia (AML). AML is a type of blood cancer. Researchers want to see how safe SNDX-5613 is, how well your body handles it, and if it helps treat AML when given with chemotherapy. You might be able to join if you are 18 to 75 years old, have newly diagnosed AML, and have specific genetic changes (KMT2Ar, NPM1c, or NUP98r mutations) in your cancer cells. The study will first look at side effects and find the best dose of SNDX-5613. The study status is currently unclear, and it plans to enroll 76 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It will involve a dose escalation phase to find the best dose, followed by a dose expansion phase to further explore safety and effectiveness.
What's involved
Participants will receive SNDX-5613 orally and chemotherapy intravenously (into a vein) during induction, consolidation, and maintenance phases. Treatment cycles will last 28 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events (side effects) from the first day of treatment until 30 days after their final dose, which could be up to approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06226571

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

Active, Not Recruiting
PHASE1Ages 18–75InterventionalTreatment
Syndax Pharmaceuticals
~76 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:SNDX-5613Chemotherapy RegimenHiDAC

At a glance

Recruiting sites
0 of 48 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation: Number of Participants with Dose-limiting Toxicities
Measured over Up to Day 42
+1 more outcome measured

Conditions

Acute Myeloid Leukemias

Explore related trials

Acute Myeloid Leukemia

Where it's being run

48 sites across 30 states
Spain8
New York4
Australia3
California2
Florida2
Illinois2
Kentucky2
North Carolina2

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Dose Escalation: Number of Participants with Dose-limiting ToxicitiesUp to Day 42
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)Day 1 through 30 days after final dose (up to approximately 3 years)