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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: 27 Aug 2026

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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

  • 20 Aug 2026 Planned primary completion date changed from 1 Aug 2026 to 1 Dec 2026.
  • 13 May 2026 According to Kura Oncology media release, the company expect to present data for ziftomenib plus venetoclax + azacitidine in R/R NPM1-m AML in 1H of 2026.
  • 20 Apr 2026 This trial has been terminated early in Germany due to Feasibility (recruitment issues, etc) issues.

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