Midostaurin Associated With Standard Chemotherapy in Patients With Core-binding Factor Leukemia

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

Timeline

Start

2018-07-01

Primary completion

2023-06-30

Completion

2024-12-31

Publications

• Background Cairoli R, Gatti A, Grillo G, Stefanucci MR, Di Camillo B, Fumagalli M, Krampera M, Nadali G, Zappasodi P, Borlenghi E, Todisco E, Ubezio M, Bernardi M, Molteni A, Basilico C, Turrini M, Greco R, Mancini V, Riva M, Bernasconi DP, Brando B, Veronese SM, Beghini A. Efficacy of Midostaurin Combined With Intensive Chemotherapy in Core Binding Factor Leukemia: A Phase II Clinical Trial. Am J Hematol. 2025 Feb;100(2):346-349. doi: 10.1002/ajh.27547. Epub 2024 Dec 10.

Drugs

Indications