A Phase II Open-Label, Single-arm, Two-Stage, Multicenter Trial of Pracinostat in Combination With Azacitidine in Elderly (Age 65 Years or Older) Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Trial Profile

A Phase II Open-Label, Single-arm, Two-Stage, Multicenter Trial of Pracinostat in Combination With Azacitidine in Elderly (Age 65 Years or Older) Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 11 Jan 2018

At a glance

  • Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Pracinostat (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Therapeutic Use
  • Sponsors Helsinn Healthcare SA; MEI Pharma
  • Most Recent Events

    • 11 Jan 2018 According to a MEI Pharma media release, based on the study results the European Medicines Agency (EMA) has granted Orphan Drug Designation to pracinostat.
    • 12 Dec 2017 Results of a post-hoc analysis assessing the Correlation between Response and Duration of Treatment, presented at the 59th Annual Meeting and Exposition of the American Society of Hematology
    • 25 Jun 2017 Results (n=41) assessing the impact of somatic mutations and their clearance on disease response and survival outcomes, presented at the 22nd Congress of the European Haematology Association
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