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A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

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A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 26 Aug 2024

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At a glance

  • Drugs Gilteritinib (Primary) ; Cytarabine; Fludarabine; Granulocyte colony-stimulating factors
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Astellas Pharma Global Development

    • Most Recent Events

    • 29 May 2024 Planned End Date changed from 31 Jul 2031 to 31 Aug 2031.
    • 24 Apr 2024 Planned End Date changed from 30 Sep 2026 to 31 Jul 2031.
    • 24 Apr 2024 Planned primary completion date changed from 30 Nov 2024 to 31 Aug 2027.

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