Prospective non-pharmacological interventional study to evaluate plasma midostaurin values ​​in patients with FLT3+ acute myeloid leukemia (SEIFEM-MIDO-TDM-2020 Study)

Project objectives

Pharmacokinetics of midostaurin in a cohort of FLT3+ AML patients treated with chemotherapy+midostaurin

Primary endpoint 

• describe plasma levels of midostaurin in patients with FLT3+ AML treated with chemotherapy+midostaurin in correlation with patient characteristics (age, weight, co-morbidities, administration of concomitant drugs).

Secondary endpoints: 

• detect any correlations between plasma levels of midostaurin and the antifungal drug proscribed as IFI prophylaxis;
• detect the correlation between the possible appearance of known adverse events and plasma levels of midostaurin;
• detect any correlation between plasma levels of midostaurin and treatment success.

Start and end date

Project Manager

Coordinating institution of the project

Other Institutions involved

• Università Campus Bio-Medico di Roma and Campus Bio-Medico University Polyclinic Foundation
• IRCCS University Hospital, Bologna
• Territorial Social-Health Authority and Civil Hospitals, Brescia
• University of Udine
• Policlinico Consortium University Hospital, Bari
• Integrated University Hospital, Verona
• IRCCS Tumor Institute “Giovanni Paul II”, Bari
• Pontine University Centre, SM Goretti Hospital, Latina
• San Gerardo Hospital, Monza
• Tor Vergata University, Rome
• IRCCS Ca' Grande Foundation Ospedale Maggiore Policlinico, Milan
• City of Health and Science University Hospital, Turin
• IRCCS Agostino Gemelli University Polyclinic Foundation, Rome