A randomised phase III study to compare arsenic trioxide (ATO) combined to ATRA versus standard ATRA and anthracycline-based chemotherapy (AIDA regimen) for newly diagnosed, non high-risk acute promyelocytic leukaemia

Trial Profile

A randomised phase III study to compare arsenic trioxide (ATO) combined to ATRA versus standard ATRA and anthracycline-based chemotherapy (AIDA regimen) for newly diagnosed, non high-risk acute promyelocytic leukaemia

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jun 2017

At a glance

  • Drugs Arsenic trioxide (Primary) ; Idarubicin; Mercaptopurine; Methotrexate; Methotrexate; Mitoxantrone; Tretinoin
  • Indications Acute promyelocytic leukaemia
  • Focus Therapeutic Use
  • Most Recent Events

    • 16 Feb 2017 Planned End Date changed from 1 Oct 2016 to 1 Oct 2017.
    • 21 Nov 2016 Status changed from active, no longer recruiting to completed, as per a Teva Pharmaceutical Industries media release.
    • 17 Oct 2016 According to a Teva Pharmaceutical media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the use of arsenic trioxide for the treatment of newly diagnosed low to intermediate risk Acute Promyelocytic Leukemia (APL) in combination with retinoic acid
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