drugset / Trial / NCT04027309
A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy
Phase 3
Active not recruiting
777 enrolled
HOVON Foundation
Astellas Pharma Global Development, Inc. · collabDeutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Activating mutations in the fms like tyrosine kinase 3 (FLT3) gene are observed in approximately 30% of patients with newly diagnosed acute myeloid leukemia (AML). Addition of the multitargeted kinase inhibitor midostaurin to standard chemotherapy prolongs event-free survival (EFS) and overall survival (OS) in patients with a FLT3 mutation. Gilteritinib is a more potent and more specific inhibitor of mutant FLT3 in comparison to midostaurin and has shown promising clinical activity in AML.
Timeline
- Start
- 2019-12-20
- Primary completion
- 2025-10
- Completion
- 2033-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gilteritinib | Small molecule | 120 mg | Oral |
| Comparator | Midostaurin | Small molecule | 50 mg | Oral |