Dose-Finding Run-in Phase I Followed by a Phase III, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations

Trial Profile

Dose-Finding Run-in Phase I Followed by a Phase III, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations

Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Mar 2017

At a glance

  • Drugs Crenolanib (Primary) ; Cytarabine; Mitoxantrone
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 15 Mar 2017 Status changed from not yet recruiting to recruiting.
    • 21 Nov 2016 According to an Arog Pharmaceuticals media release, the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has granted orphan drug designation for crenalonib for the treatment of acute myeloid leukemia.
    • 27 Nov 2014 New trial record
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