Midostaurin Associated With Standard Chemotherapy in Patients With Core-binding Factor Leukemia
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this single-arm, open label, phase-II trial, is to determine whether the
association of Midostaurin to standard induction, consolidation therapy and in maintenance
therapy as single agent, is effective in decrease relapse incidence, in patients with
CBF-AML. The single-arm, open label, phase-II study is based on data obtained from previous
clinical and pre-clinical studies, obtained by use of Midostaurin in patients with Acute
Myeloid Leukemia (with or without FLT3 mutations) and in patients with Mast cell disorders
(characterized by mutations in the C-KIT gene). The investigators believe that Midostaurin,
associated with standard therapy Anthracycline/AraC Induction, to the consolidation regimen
with high doses of araC and maintenance therapy to single agent in patients with acute
myeloid leukemia core-binding factor can significantly reduce the incidence of recurrence of
the disease, occurring in 40-50% of cases treated with standard therapy