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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 12 May 2026

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At a glance

  • Drugs Cytarabine (Primary) ; Daunorubicin (Primary) ; Idarubicin (Primary) ; Revumenib (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions
  • Sponsors Syndax Pharmaceuticals

Most Recent Events

  • 08 Dec 2025 According to Syndax Pharmaceuticals Media Release, data from the trial were presented at the 2025 ASH Annual Meeting.
  • 08 Dec 2025 Results presented in the Syndax Pharmaceuticals Media Release
  • 27 Nov 2025 According to a Syndax Pharmaceuticals media release, data form the trial were accepted for presentation at the 67th American Society of Hematology (ASH) Annual Meeting being held in Orlando, Florida, December 6-9, 2025.

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