A Phase 3 Open-Label Randomized Study of Quizartinib Monotherapy Versus Salvage Chemotherapy in Subjects with FLT3-ITD Positive Acute Myeloid Leukemia (AML) Refractory To or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

Trial Profile

A Phase 3 Open-Label Randomized Study of Quizartinib Monotherapy Versus Salvage Chemotherapy in Subjects with FLT3-ITD Positive Acute Myeloid Leukemia (AML) Refractory To or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2017

At a glance

  • Drugs Quizartinib (Primary) ; Cytarabine; Etoposide; Fludarabine; Granulocyte colony-stimulating factors; Idarubicin; Mitoxantrone
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms QUANTUM-R
  • Sponsors Ambit Biosciences Corporation; Daiichi Sankyo Inc
  • Most Recent Events

    • 28 Nov 2017 Planned End Date changed from 1 Apr 2018 to 1 Sep 2018.
    • 28 Nov 2017 Planned primary completion date changed from 1 Feb 2018 to 1 Jul 2018.
    • 14 Nov 2017 According to Daiichi Sankyo media release,data will be presented at the 59th Annual Meeting of the American Society of Hematology (ASH)
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