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

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.

Conditions

Acute Myeloid Leukemias

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Acute Myeloid Leukemias
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Medical Center, Duarte, California, United States, 91010

Orlando

AdventHealth Blood & Marrow Transplant Center, Orlando, Florida, United States, 32804

Louisville

Norton Cancer Institute, St. Matthews Campus, Louisville, Kentucky, United States, 40207

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Syracuse

SUNY Upstate Medical University, Syracuse, New York, United States, 13210

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Houston

The University of Texas, MD Anderson Cancer Center, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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).

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Syndax Pharmaceuticals,

Study Record Dates

2027-02