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HEAT-AML (Hydroxyurea-Enhanced Ara-C Treatment of Adult Acute Myeloid Leukaemia): A phase I/II multicenter study to assess the tolerability and efficacy of the addition of hydroxyurea to standard ara-C and daunorubicin-based therapy for adults (age ≥ 18 years of age) with newly diagnosed acute myeloid leukaemia (AML)

Trial Profile

HEAT-AML (Hydroxyurea-Enhanced Ara-C Treatment of Adult Acute Myeloid Leukaemia): A phase I/II multicenter study to assess the tolerability and efficacy of the addition of hydroxyurea to standard ara-C and daunorubicin-based therapy for adults (age ≥ 18 years of age) with newly diagnosed acute myeloid leukaemia (AML)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 Mar 2024

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At a glance

  • Drugs Hydroxycarbamide (Primary) ; Cytarabine; Daunorubicin; Midostaurin
  • Indications Acute myeloid leukaemia
  • Focus Therapeutic Use
  • Acronyms HEAT-AML
  • Most Recent Events

    • 01 Dec 2022 Results (n=9) reporting PK, safety and efficacy data from phase 1 portion of this trial published in the Journal of Internal Medicine
    • 05 Aug 2022 New trial record
    • 17 Jun 2022 Results of the first 9 patients in the run-in phase 1 part of the study presented at the 27th Congress of the European Haematology Association

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