Clinical Trial

FLT3-ITD Targeted Therapy in Fit AML Patients

Study acronym: FIT-AML
Not Yet Recruiting Phase 2/3
View on ClinicalTrials.gov →
Summary
This international, multicenter, randomized (1:1), open-label phase II/III trial will evaluate the efficacy and safety of gilteritinib combined with azacitidine and venetoclax (experimental arm) versus standard "7+3" induction plus a FLT3inhibitor (quizartinib or midostaurin) (control arm) in newly diagnosed FLT3-ITD mutated AML patients eligible for intensive chemotherapy.
Trial Details
NCT Number NCT07425808
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: Fondazione GIMEMA, Astellas Pharma Inc
Conditions AML (Acute Myeloid Leukemia)
Enrollment 230 participants
Start Date 2026-12-01
Primary Completion 2028-10-01 (estimated)
Study Completion 2032-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-23