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A Phase II, Open-label, Single Arm Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Twice Daily Midostaurin ( PKC412) Combined With Standard Chemotherapy and as a Single Agent Post-consolidation Therapy in Children With Untreated FLT3-mutated AML

Trial Profile

A Phase II, Open-label, Single Arm Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Twice Daily Midostaurin ( PKC412) Combined With Standard Chemotherapy and as a Single Agent Post-consolidation Therapy in Children With Untreated FLT3-mutated AML

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 27 Nov 2019

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At a glance

  • Drugs Midostaurin (Primary) ; Cytarabine; Daunorubicin; Daunorubicin liposomal; Etoposide; Fludarabine; Idarubicin; Mitoxantrone
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 06 Nov 2019 Trial design results released at the 61st Annual Meeting and Exposition of the American Society of Hematology.
    • 18 May 2019 Planned End Date changed from 28 Apr 2025 to 12 May 2027.
    • 18 May 2019 Planned primary completion date changed from 28 Apr 2020 to 12 May 2022.
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