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

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

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Oct 2017

At a glance

  • Drugs Midostaurin (Primary)
  • Indications Leukaemia; Systemic mastocytosis
  • Focus Therapeutic Use
  • Sponsors Novartis; Novartis Pharmaceuticals Corporation
  • Most Recent Events

    • 22 Sep 2017 This trial has been completed in Germany according to European Clinical Trials Database record.
    • 22 Sep 2017 This trial has been completed in Belgium according to European Clinical Trials Database record.
    • 20 Sep 2017 According to a Novartis media release, the European Commission (EC) approved Rydapt for use as monotherapy for the treatment of adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia. The approval applies to all 28 EU member states, plus Iceland, Liechtenstein and Norway.
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