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Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia

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Trial Profile

Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 03 Dec 2025

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At a glance

  • Drugs Gilteritinib (Primary) ; Ziftomenib (Primary) ; Azacitidine; Cytarabine; Daunorubicin; Fludarabine; Granulocyte colony-stimulating factors; Idarubicin; Venetoclax
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions
  • Acronyms KOMET-008
  • Sponsors Kura Oncology

Most Recent Events

  • 04 Nov 2025 According to Kura Oncology media release, company announced present preliminary data from the KOMET-008 cohort evaluating ziftomenib in combination with the FLT3 inhibitor gilteritinib in patients with R/R NPM1-m AML in 2026.
  • 10 Jan 2024 Planned initiation date changed from 1 Dec 2023 to 1 Jan 2024.
  • 13 Dec 2023 Status changed from not yet recruiting to recruiting.

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