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Phase III Randomized Study to Improve Overall Survival in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus Mycophenolate Mofetil Prophylaxis of Graft Versus Host Disease in Allografted Patients in First CR : a Backbone InterGroup-1 Trial

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Trial Profile

Phase III Randomized Study to Improve Overall Survival in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus Mycophenolate Mofetil Prophylaxis of Graft Versus Host Disease in Allografted Patients in First CR : a Backbone InterGroup-1 Trial

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 06 Jun 2024

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At a glance

  • Drugs Vosaroxin (Primary) ; Ciclosporin; Ciclosporin; Cytarabine; Daunorubicin; Idarubicin; Methotrexate; Mycophenolic acid
  • Indications Acute myeloid leukaemia; Graft-versus-host disease
  • Focus Therapeutic Use
  • Acronyms BIG-1
  • Most Recent Events

    • 08 Dec 2020 Results of a sub study (n=70) presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology
    • 20 May 2017 New trial record
    • 08 May 2017 According to Sunesis Pharmaceuticals media release, vosaroxin has been selected as a treatment arm in this trial, which is expected to begin dosing imminently and will enroll up to 200 patients with favorable or intermediate risk AML, who will receive consolidation therapy of intermediate dose cytarabine with vosaroxin.
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