Activating mutations in the gene for fms-like tyrosine kinase 3 (FLT3) are observed in around 30 % of patients with newly diagnosed acute myeloid leukemia (AML). The addition of the multicenter kinase inhibitor midostaurin to standard chemotherapy prolongs event-free survival (EFS) and overall survival (OS) in patients with an FLT3 mutation. Gilteritinib is a more potent and specific inhibitor of mutated FLT3 compared to midostaurin and has shown promising clinical activity in AML.
Aim of the study
The study investigates the effect and safety of gilteritinib in patients with AML or MDS-EB2 and an FLT3 mutation. We want to find out whether the disease can be controlled more effectively and for longer with gilteritinib and chemotherapy compared to standard treatment (chemotherapy in combination with midostaurin).
Who can take part?
Patients with previously untreated acute myeloid leukemia (AML) or previously untreated myelodysplastic syndrome (MDS-EB2) with FLT3 mutation
Procedure
The individual treatment lasts a total of around 18 months. As part of this study, you will be monitored over a period of 10 years after you start the study. If you decide to participate, you will be randomly assigned to one of two treatment groups before the start of treatment: with midostaurin or with gilteritinib. The first phase of treatment, known as induction therapy, consists of two consecutive cycles of various forms of chemotherapy. Chemotherapy is combined with either midostaurin or gilteritinib. Once the first phase has been completed, an assessment is made as to whether the second phase (consolidation therapy) can be carried out.
Compensation
None
Original study name
A multicenter, open-label, randomized phase 3 study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one year of maintenance therapy in patients with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndromes with excess blasts-2 (MDS-EB2) with FLT3 mutations who are eligible for intensive chemotherapy
BASEC number
2020-00182
Financial support from
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)