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A Phase III, Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Of Pracinostat In Combination With Azacitidine In Patients ≥18 Years With Newly Diagnosed Acute Myeloid Leukemia Unfit For Standard Induction Chemotherapy

Trial Profile

A Phase III, Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Of Pracinostat In Combination With Azacitidine In Patients ≥18 Years With Newly Diagnosed Acute Myeloid Leukemia Unfit For Standard Induction Chemotherapy

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 16 Jun 2022

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At a glance

  • Drugs Pracinostat (Primary) ; Azacitidine; Azacitidine
  • Indications Acute myeloid leukaemia
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms PRIMULA
  • Sponsors Helsinn
  • Most Recent Events

    • 03 Apr 2022 This trial has been completed in Hungary (Date of the global end of the trial : 02-Jul-2020), according to European Clinical Trials Database record.
    • 02 Jul 2020 According to a Helsinn media release, Primary endpoint (Overall survival) has not been met.
    • 02 Jul 2020 According to a Helsinn media release, company discontinued this trial unfit to receive standard intensive chemotherapy as it failed to meet the primary endpoint of overall survival compared to the control group. Based on the outcome of the interim analysis, the decision was made to discontinue the recruitment of patients and end the study. Results of the interim analysis demonstrated lack of efficacy.
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