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A Phase 3, Multicenter, Open Label, Randomized, Non-comparative Two-arm Study of Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Adult Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an Isocitrate Dehydrogenase-1 (IDH1) Mutation (PyramIDH Study)

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Trial Profile

A Phase 3, Multicenter, Open Label, Randomized, Non-comparative Two-arm Study of Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Adult Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an Isocitrate Dehydrogenase-1 (IDH1) Mutation (PyramIDH Study)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Feb 2025

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At a glance

  • Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Ivosidenib (Primary)
  • Indications Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Acronyms (PyramIDH)
  • Sponsors Institut de Recherches Internationales Serviers

Most Recent Events

  • 09 Jan 2025 According to Servier media release, Phase 3 PyramIDH clinical trial has been initiated, and sites are actively recruiting across the globe.
  • 10 Dec 2024 Study design presented at the 66th American Society of Hematology Annual Meeting and Exposition.
  • 10 Dec 2024 Status changed from not yet recruiting to recruiting.

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