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

NCT03591510 ↗

Phase 2 Active not recruiting 22 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-03-13
Primary completion
2029-05-18
Completion
2029-05-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Midostaurin Small molecule 30 mg/m2 Oral
Subject Midostaurin Small molecule 60 mg/m2 Oral
Background Cytarabine Small molecule 1000 mg/m2 —
Background Cytarabine Small molecule 2000 mg/m2 —
Background Cytarabine Small molecule 3000 mg/m2 —
Background Daunorubicin Small molecule 60 mg/m2 —
Background Etoposide Small molecule 100 mg/m2 —
Background Fludarabine Small molecule 30 mg/m2 —
Background Idarubicin Small molecule 12 mg/m2 —
Background Mitoxantrone Small molecule 10 mg/m2 —

Indications

acute myeloid leukemia