Clinical Trial

Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia

Not Yet Recruiting Phase 2
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Summary
The goal of this clinical trial is to evaluate the efficacy of gilteritinib as induction therapy in FLT3-positive adult acute myeloid leukemia patients. The main question it aims to answer is: Is gilteritinib in combination to chemotherapy able to improve the complete remission rate of FLT3-positive AML? Participants will receive up to 2 induction cycles with gilteritinib in combination with FLAI (fludarabine, cytarabine, idarubicine) and up to 3 consolidation cycles with gilteritinib and high-dose cytarabine.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-30.
Trial Details
NCT Number NCT06667973
Lead Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions Acute Myeloid Leukemia, FLT3 Gene Mutation, Adult AML, Diagnosis
Enrollment 80 participants
Start Date 2025-06
Primary Completion 2028-08 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2025-03-12