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: 22 Apr 2025

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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 Pharma A.G.; Novartis Pharmaceuticals

18 Apr 2025 Planned number of patients changed from 52 to 24.
18 Apr 2025 Planned End Date changed from 15 Feb 2029 to 1 Oct 2029.
18 Apr 2025 Planned primary completion date changed from 18 Aug 2025 to 3 May 2027.

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