Overview

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 M

Status:
Recruiting

Trial end date:
2032-09-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Stichting Hemato-Oncologie voor Volwassenen Nederland

Collaborators:

Astellas Pharma Global Development, Inc.
Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG)

Treatments:

Midostaurin
Staurosporine