Prospective, interventional, non-randomized, pharmacokinetic, multicenter study to evaluate plasma levels of gilteritinib in patients with relapsed/refractory FLT3+ acute myeloid leukemia in the presence or absence of triazoles

Project objectives

Primary endpoint 

• Quantification of gilteritinib plasma concentrations in patients with R/R FLT3 AML+ exposed to concomitant triazole antifungal regimens.

Secondary endpoints: 

• Pharmacokinetic profile of gilteritinib in the presence or absence of triazoles.
• Quantification of plasma concentrations of triazoles in patients with R/R FLT3 AML+ treated with gilteritinib
• Post hoc analysis of potential correlations between gilteritinb plasma levels in the presence or absence of triazoles and hematological (febrile neutropenia, anemia, thrombocytopenia) or non-hematological (QTc interval prolongation) adverse events.

• Post hoc analysis of the median time to the onset of invasive fungal infections in patients treated with gilteritinib.

Start and end date

Project Manager

Prof. Girogio Minotti, Head of Pharmaceutical Sciences UR, Campus Bio-Medico University and Campus Bio-Medico University Polyclinic Foundation, Rome - Co-Principal Investigator

Coordinating institution of the project

Other Institutions involved

• Università Campus Bio-Medico di Roma and Campus Bio-Medico University Polyclinic Foundation
• IRCCS University Hospital of Bologna
• Mauritian Order Hospital of Turin Ravenna
• AUSL of Romagna, Hematology Ravenna
• University Hospital, Udine
• IRCCS “Regina Elena” National Cancer Institute, RomeTerritorial Social Health Company and Civil Hospitals, Brescia
• University of Rome "Tor Vergata", Tor Vergata Polyclinic Foundation
• Modena University Hospital
• IRCCS Ca' Grande Foundation Ospedale Maggiore Policlinico, Milan
• IRCCS, Agostino Gemelli University Polyclinic Foundation, Rome
• Vito Fazzi Hospital, Lecce
• Integrated University Hospital, Verona
• University Hospital, Parma
• Sant' University Hospital CompanyAndrea. Rome
• Sant'Eugenio Hospital, Rome
• Hospital San Giovanni Sorrowful, Rome
• Varese Circle Hospital, Varese
• Policlinico Riuniti – University Hospital, Foggia
• IRCCS Tumor Institute “Giovanni Paul II”, Bari
• Policlinico Consortium University Hospital, Bari

Funding source(s).