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A single arm, Phase II, Open-label Study to determine the efficacy of 100 mg twice daily oral dosing of midostaurin administered to patients with Aggressive Systemic Mastocytosis or Mast Cell Leukemia +/- an associated hematological clonal non-mast cell lineage disease

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Trial Profile

A single arm, Phase II, Open-label Study to determine the efficacy of 100 mg twice daily oral dosing of midostaurin administered to patients with Aggressive Systemic Mastocytosis or Mast Cell Leukemia +/- an associated hematological clonal non-mast cell lineage disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 11 Jan 2022

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At a glance

  • Drugs Midostaurin (Primary)
  • Indications Mast Cell Leukemia; Systemic mastocytosis
  • Focus Therapeutic Use
  • Sponsors Novartis; Novartis Pharmaceuticals Corporation

Most Recent Events

  • 03 Dec 2021 Results from EXPLORER, PATHFINDER, D2201 and A2213 comparing the relative efficacy of avapritinib versus midostaurin for the treatment of AdvSM using matching-adjusted indirect comparison (MAIC) methodology, presented at the 24th Annual European Congress of the International Society for Pharmacoeconomics
  • 10 May 2020 Results (N=89), assessing quality of life and MC mediator related symptoms, published in the Journal of Allergy and Clinical Immunology
  • 19 Jun 2018 Status changed from active, no longer recruiting to completed.

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