SEIFEM-MIDO-TDM-2020 study (dr. Francesco Marchesi)
This is a non-pharmacological interventional prospective study aimed to evaluating plasmatic midostaurin concentrations in patients with FLT3-mut acute myeloid leukemia receiving midostaurin + chemotherapy. The main objective of the study is to describe midostaurin plasmatic levels in these patients and correlating it with clinical features, adverse events and outcome. The estimated sample size is of about 40 patients. The study is currently under review by Ethical Committee of the coordinator centre (Spedali Civili di Brescia, PI: dr. Chiara Cattaneo). The estimated accrual start date will be January 2021. All collected blood samples will be send at the Pharmacology Lab of Campus Bio-Medico University (Rome, dr. Menna) and analyzed for midostaurin and its metabolites.