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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

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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: 23 May 2024

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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

    • 01 May 2024 Results evaluating the efficacy/safety of pracinostat administered with AZA in adult patients with newly diagnosed AML ineligible to receive IC, published in the Leukemia Research
    • 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.

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