Trial Profile

A Phase 3, Multicenter, Open-label, Randomized, 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 (AML) or Myelodysplastic Syndromes With Excess Blasts-2 (MDS-EB2) With FLT3 Mutations Eligible for Intensive Chemotherapy (HOVON 156 AML / AMLSG 28-18)

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 31 Mar 2026

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At a glance

09 Mar 2026 Primary endpoint has not been met. (Overal survival (OS))
17 Dec 2024 Planned primary completion date changed from 1 Dec 2024 to 1 Oct 2025.
14 Jun 2023 Status changed from recruiting to active, no longer recruiting.

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