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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

Phase
Phase 1
Sponsor
Syndax Pharmaceuticals
Enrollment
76
Timeline
May 2024 → Feb 2027
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Established, pathologically confirmed diagnosis of AML by World Health Organization 2022 criteria.
  • 2Previously untreated AML and eligible to receive intensive chemotherapy.
  • 3KMT2Ar, NPM1c, or NUP98r mutations identified by local laboratory prior to the first dose of SNDX-5613.
  • 4Eastern Cooperative Oncology Group performance status ≤2 and ≤1 if \>65 years old .
  • 5Adequate liver, kidney, and cardiac function.

Exclusion Criteria

  • 1Diagnosis of acute promyelocytic leukemia.
  • 2Clinically active central nervous system leukemia (blasts detected in cerebrospinal fluid, radiographic or clinical signs and symptoms).
  • 3Fridericia's corrected QT interval (QTcF) \>450 milliseconds (average of triplicate), diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
  • 4Any gastrointestinal issue of the upper gastrointestinal tract that might affect oral drug absorption or ingestion.
  • 5Cirrhosis with a Child-Pugh score of B or C.
  • 6Any 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.
  • 7Hepatitis B, Hepatitis C, or HIV-positive with detectable viral load.
  • 8Documented active, uncontrolled infection.
  • 9Uncontrolled disseminated intravascular coagulation.
  • 10Lactating/breast feeding or pregnant.
  • 11Use of prohibited concomitant chemotherapy, radiation therapy, or immunotherapy.
  • 12Use of strong CYP3A4 inducers or inhibitors (except for Itraconazole, Ketoconazole, Posaconazole, or Voriconazole).

Locations

43 sites participating in this study

Emory Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

William Blum, MD

wblum@emory.edu

UCLA Medical Hematology

Burbank, California 91505

Recruiting

Gary Schiller, MD

gschiller@mednet.ucla.edu

City of Hope Medical Center

Duarte, California 91010

Recruiting

Ibrahim Aldoss, M.D.

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →