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International Randomised Phase III Clinical Trial in Children with Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination with Induction Chemotherapy

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International Randomised Phase III Clinical Trial in Children with Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination with Induction Chemotherapy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Jun 2024

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At a glance

  • Drugs Gemtuzumab ozogamicin (Primary) ; Busulfan; Cyclophosphamide; Cytarabine; Daunorubicin; Fludarabine; Mitoxantrone
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms MyeChild01

    • Most Recent Events

    • 12 Dec 2023 Results (n=749 ) of Outcomes for Children with High Risk Acute Myeloid Leukemia, presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 04 Dec 2018 Results (at data cut off: 27 July 2018) assessing tolerability of 2 doses of Gemtuzumab-ozogamicin in combination with induction chemotherapy, presented at the 60th Annual Meeting and Exposition of the American Society of Hematology.
    • 22 Feb 2017 Planned End Date changed from 1 Dec 2032 to 28 Apr 2032.

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