Clinical Trial

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

Study acronym: HOVON 156 AML
Active, Not Recruiting Phase 3
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Record status
This record was last updated December 17, 2024 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2019-07-18; most recent amendment 2024-12-12.
Status change: Recruiting → Active, Not Recruiting 2023-06-14
Status change: Suspended → Recruiting 2023-03-27
Status change: Recruiting → Suspended 2023-01-05
Status change: Not Yet Recruiting → Recruiting 2020-01-16
Trial Details
NCT Number NCT04027309
Lead Sponsor Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborators: Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG), Astellas Pharma Global Development, Inc.
Conditions Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
Enrollment 777 participants
Start Date 2019-12-20
Primary Completion 2025-10 (estimated)
Study Completion 2033-06 (estimated)
Updated on ClinicalTrials.gov 2024-12-17