A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML

• Status: Recruiting
• Trial end date: 2029-02-15

Summary

This study will evaluate the safety, efficacy and pharmacokinetics of midostaurin in combination with standard chemotherapy in pediatrics patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia. The study has two parts: Part 1 to define the Recommended Phase 2 Dose, and Part 2 to evaluate safety and tolerability and efficacy of midostaurin. Both parts will consist of 2 induction blocks, 3 consolidation blocks, 12 cycles of post-consolidation consisting of continuous therapy with midostaurin, and a follow-up phase.

• Phase: Phase 2

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cytarabine; Daunorubicin; Etoposide; Etoposide phosphate; Fludarabine; Fludarabine phosphate; Idarubicin; Midostaurin; Mitoxantrone; Staurosporine