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: 07 Apr 2024
Price :
$35
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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
- 15 Jun 2023 According to Trial design presented at the 28th Congress of the European Haematology Association, part 1 of this study has been completed (four patients have been enrolled and treated). Recruitment completion expected on Feb 2024.
- 15 Jun 2023 Trial design presented at the 28th Congress of the European Haematology Association
- 23 Jun 2021 Planned number of patients changed from 23 to 50.