Search / Trial NCT06226571

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

Launched by SYNDAX PHARMACEUTICALS · Jan 23, 2024

Trial Information

Current as of December 30, 2024

Recruiting

Keywords

Sndx 5613 Lysine Specific Methyltransferase 2 A Kmt2 A/Mll Nucleophosmin 1 Npm1 Nucleoporin 98 Nup98 Aml

ClinConnect Summary

This clinical trial is studying a new treatment called SNDX-5613, which is being tested in combination with intensive chemotherapy for patients with newly diagnosed acute myeloid leukemia (AML) that have specific gene changes (mutations) known as KMT2A, NPM1, or NUP98. The main goals of the study are to see how safe this treatment is, how well it works, and how the body processes the drug.

To be eligible for the trial, participants need to have a confirmed diagnosis of AML and have never been treated before. They must also have one of the mentioned gene mutations and be in good overall health, meaning they can perform daily activities without significant issues. Participants can expect close monitoring throughout the study to ensure their safety and to gather information on how the treatment is affecting them. It’s important to note that certain medical conditions or recent health issues could exclude someone from participating, so a thorough health review will be conducted before joining the trial.

Gender

ALL

Eligibility 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).

About Syndax Pharmaceuticals

Syndax Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to advancing innovative therapies for the treatment of cancer and other serious diseases. With a strong focus on developing novel immuno-oncology and epigenetic therapies, Syndax aims to improve patient outcomes through targeted approaches that harness the body's immune system and address key biological pathways in tumor progression. The company is committed to rigorous scientific research and collaboration, driving the development of its pipeline candidates through various phases of clinical trials to bring transformative treatments to patients in need.

Locations

Chicago, Illinois, United States

Cleveland, Ohio, United States

Saint Louis, Missouri, United States

Duarte, California, United States

Syracuse, New York, United States

Tampa, Florida, United States

Houston, Texas, United States

Atlanta, Georgia, United States

Louisville, Kentucky, United States

Salt Lake City, Utah, United States

Morgantown, Virginia, United States

Orlando, Florida, United States

Charleston, South Carolina, United States

Burbank, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0