RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2024-05-21
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06226571

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Established, pathologically confirmed diagnosis of AML by World Health Organization 2022 criteria.
  2. * Previously untreated AML and eligible to receive intensive chemotherapy.
  3. * KMT2Ar, NPM1c, or NUP98r mutations identified by local laboratory prior to the first dose of SNDX-5613.
  4. * Eastern Cooperative Oncology Group performance status ≤2 and ≤1 if \>65 years old .
  5. * Adequate liver, kidney, and cardiac function.
  1. * Diagnosis of acute promyelocytic leukemia.
  2. * Clinically active central nervous system leukemia (blasts detected in cerebrospinal fluid, radiographic or clinical signs and symptoms).
  3. * 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.
  4. * Any gastrointestinal issue of the upper gastrointestinal tract that might affect oral drug absorption or ingestion.
  5. * Cirrhosis with a Child-Pugh score of B or C.
  6. * 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.
  7. * Hepatitis B, Hepatitis C, or HIV-positive with detectable viral load.
  8. * Documented active, uncontrolled infection.
  9. * Uncontrolled disseminated intravascular coagulation.
  10. * Lactating/breast feeding or pregnant.
  11. * Use of prohibited concomitant chemotherapy, radiation therapy, or immunotherapy.
  12. * Use of strong CYP3A4 inducers or inhibitors (except for Itraconazole, Ketoconazole, Posaconazole, or Voriconazole).

Contacts and Locations

Study Contact

Syndax Pharmaceuticals
CONTACT
781-419-1400
clinicaltrials@syndax.com

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States
AdventHealth Blood & Marrow Transplant Center
Orlando, Florida, 32804
United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Syndax Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-21
Study Completion Date2027-02

Study Record Updates

Study Start Date2024-05-21
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • SNDX-5613
  • Lysine-specific Methyltransferase 2A
  • KMT2A/MLL
  • Nucleophosmin 1
  • NPM1
  • Nucleoporin 98
  • NUP98
  • AML

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemias