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FLT3-ITD Targeted Therapy in Fit AML Patients

Study acronym: FIT-AML
StatusNot Yet Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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
(from sponsor)		 AML (Acute Myeloid Leukemia)
Related terms Leukemia, Myeloid, Acute
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov