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A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

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Trial Profile

A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Apr 2024

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At a glance

  • Drugs Revumenib (Primary) ; Cobicistat; Fluconazole; Isavuconazole; Itraconazole; Ketoconazole; Posaconazole; Voriconazole
  • Indications Acute biphenotypic leukaemia; Acute myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; First in man; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms AUGMENT-101
  • Sponsors Syndax Pharmaceuticals

    • Most Recent Events

    • 08 Apr 2024 According to a Syndax Pharmaceuticals media release, Of 57 patients enrolled in AUGMENT-101 with central confirmation of their KMT2Ar status and sufficient follow-up to be included in the efficacy-evaluable population.
    • 08 Apr 2024 According to a Syndax Pharmaceuticals media release, pediatric data was featured in a Plenary Session titled "Pivotal Phase 2 Results of AUGMENT-101 for Revumenib in KMT2Ar Acute Leukemia: Pediatric Experience" at the 2024 American Society of Pediatric Hematology/Oncology (ASPHO) Conference held April 3 - 6, 2024 in Seattle, Washington.
    • 08 Apr 2024 Results from phase 2 portion published in a Syndax Pharmaceuticals media release
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