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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Feb 2024

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At a glance

  • Drugs Quizartinib (Primary) ; Cytarabine; 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

  • 02 Feb 2021 Status changed from active, no longer recruiting to completed.
  • 12 Dec 2020 This trial has been completed in Czech Republic (Global End Date: 08 Sep), according to European Clinical Trials Database record.
  • 08 Dec 2020 This trial has been completed in Hungary and Croatia as per European Clinical Trials Database record

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