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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: 21 Jun 2019

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

    • 21 Jun 2019 According to a Daiichi Sankyo Company media release, Daiichi Sankyo Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of quizartinib for the treatment of adults with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Daiichi Sankyo is evaluating the Complete Response Letter and will determine next steps.
    • 18 Jun 2019 According to a Daiichi Sankyo Company media release, based on the results of this study and a phase II study (NCT02984995), the the Ministry of Health, Labor and Welfare (MHLW) of Japan has approved VANFLYTA (quizartinib), an oral FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML), as detected by an MHLW-approved test.
    • 04 Jun 2019 Results published in the Lancet Oncology
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