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S0535, A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia

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Trial Profile

S0535, A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 Apr 2023

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At a glance

  • Drugs Arsenic trioxide (Primary) ; Daunorubicin (Primary) ; Gemtuzumab ozogamicin (Primary) ; Mercaptopurine (Primary) ; Methotrexate (Primary) ; Tretinoin (Primary)
  • Indications Acute promyelocytic leukaemia
  • Focus Therapeutic Use

    • Most Recent Events

    • 14 Aug 2017 Status changed from active, no longer recruiting to completed.
    • 06 Dec 2016 Primary endpoint (Mortality rate at 6 weeks) has been met, according to the results presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 06 Dec 2016 Primary endpoint (Continuous complete remission at 3 years) has been met, according to the results presented at the 58th Annual Meeting and Exposition of the American Society of Hematology

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