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[Randomized Study Comparing the Exploratory Treatment For Gemtuzumab ozogamicin / Cytarabine to Standard Treatment For Idarubicin / Cytarabinechez The Elderly 65 to 80 Years and having acute myeloid leukemia with favourable or intermediate-risk cytogenetics] .

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Trial Profile

[Randomized Study Comparing the Exploratory Treatment For Gemtuzumab ozogamicin / Cytarabine to Standard Treatment For Idarubicin / Cytarabinechez The Elderly 65 to 80 Years and having acute myeloid leukemia with favourable or intermediate-risk cytogenetics] .

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 07 Feb 2024

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At a glance

  • Drugs Gemtuzumab ozogamicin (Primary) ; Cytarabine; Idarubicin
  • Indications Acute myeloid leukaemia
  • Focus Therapeutic Use
  • Acronyms ALFA1401; ALFA1401-Mylofrance 4

    • Most Recent Events

    • 01 Feb 2024 Status changed from recruiting to completed.
    • 14 Dec 2021 Primary endpoint (Prolonged event-free survival (EFS)) has not been met, as per results presented at the 63rd American Society of Hematology Annual Meeting and Exposition.
    • 14 Dec 2021 Results (n=225; Between January 2016 and March 2019) assessing the replacement of the anthracycline by GO might also improve EFS in older patients, presented at the 63rd American Society of Hematology Annual Meeting and Exposition.
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