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
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
- 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