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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

Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 23 Dec 2018

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 Pharmaceuticals
  • Most Recent Events

    • 06 Dec 2018 Planned initiation date changed from 12 Oct 2018 to 28 Dec 2018.
    • 24 Jul 2018 New trial record
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