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RecruitingLast updated: 24 June 2025

SNDX: This study is recruiting people with newly diagnosed acute myeloid leukaemia to evaluate the safety and effectiveness of a targeted therapy drug in combination with intensive chemotherapyA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18 - 75

Trial acronym

SNDX

Clinical summary

Summary

You may be eligible for this study if you have newly diagnosed acute myeloid leukaemia (AML) with alternations in KMT2A, NPM1, or NUP98 genes.

The study has two portions: Dose Escalation and Dose Expansion.

The Dose Escalation portion will identify the maximum toelrated dose, or if different, the recommended Phase 2 dose of SNDX-5613 targeted therapy to be used in combination with intensive chemotherapy and in maintenance monotherapy following intensive chemotherapy. 

The Dose Expansion portion will explore the safety and preliminary efficacy of SNDX-5613 in expansion cohorts are tolerated dose levels.

Chemotherapy will be a combination of cytarabine and either daunorubicin or idarubicin. 

In both Dose Escalation and Dose Expanion, the treatment period will consist of an inductino phase (up to 2 cycles), a consolidation phase (up to 4 cycles and could include haematopoietic stem cell transplant for participants who are transplant eligible and have an available donor), and a maintenance monotherapy phase with SNDX-5613. The cycle duration will be 28 days. 

Conditions

This trial is treating people with acute myeloid leukaemia with KMT2Ar, NPM1c, or NUP98r mutations

Eligibility

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).

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Syndax Pharmaceuticals

Scientific Title

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

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