drugset / Trial / NCT06667973

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

NCT06667973

Phase 2 Not yet recruiting 80 enrolled GIMEMA Foundation
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-06
Primary completion
2028-08
Completion
2030-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Gilteritinib Small molecule 120 mg Oral