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A Two-Stage, Open-Label Phase 2 Study of Pracinostat and Azacitidine in Patients With IPSS-R High and Very High Risk Myelodysplastic Syndromes Previously Untreated With Hypomethylating Agents

Trial Profile

A Two-Stage, Open-Label Phase 2 Study of Pracinostat and Azacitidine in Patients With IPSS-R High and Very High Risk Myelodysplastic Syndromes Previously Untreated With Hypomethylating Agents

Recruiting
Phase of Trial: Phase II

Latest Information Update: 07 Feb 2019

At a glance

  • Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Pracinostat (Primary)
  • Indications Myelodysplastic syndromes
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Helsinn Healthcare SA
  • Most Recent Events

    • 07 Feb 2019 According to a MEI Pharma media release, results from this study including response and 1-year survival, are expected to be available by the end of 2019.
    • 04 Dec 2018 Interim results (n=39; data cut off 25 May 2018) presented at the 60th Annual Meeting and Exposition of the American Society of Hematology
    • 03 Dec 2018 According to a Helsinn media release, as of the end of Oct 2018, 55 patients have completed at least one cycle of therapy.The discontinuation rate reported today continues to meet the pre-defined threshold from the planned interim analysis conducted in May 2018 and is consistent with the discontinuation rate for azacitadine administered as a single agent.
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