The goal of this clinical trial is to evaluate the efficacy of gilteritinib as induction therapy in FLT3-positive adult acute myeloid leukemia patients. The main question it aims to answer is:
Is gilteritinib in combination to chemotherapy able to improve the complete remission rate of FLT3-positive AML?
Participants will receive up to 2 induction cycles with gilteritinib in combination with FLAI (fludarabine, cytarabine, idarubicine) and up to 3 consolidation cycles with gilteritinib and high-dose cytarabine.
The patient is ≥ 18 and ≤65 years old.
The patient has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 to 2.
Left ventricular ejection fraction (LVEF) ≥institutional lower limit of normal as measured by multigated acquisition (MUGA) scan or 2-dimensional (2-D) echocardiography (ECHO) within 21 days before start of therapy and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG).
ECG: QTcF≤450 male ≤480 female
Patient was diagnosed as acute promyelocytic leukemia.
Patient has BCR-ABL-positive leukemia or chronic myelogenous leukemia in blast crisis.
Patient has clinically active central nervous system leukemia.
Patient has been diagnosed with another malignancy, unless disease-free for at least 3 years. Subjects with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, papillary thyroid carcinoma, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Subjects with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed or treated with definitive radiotherapy.
Single group
Gilteritinib
DrugGilteritinib fumarate is an oral, selective FLT3 and AXL inhibitor. It is a type 1 inhibitor, active against both the FLT3-ITD and FLT3-TKD mutations. Gilteritinib inhibits FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3-ITD, FLT3-D835Y, and FLT3-ITD-D835Y, and it induces apoptosis in leukemic cells expressing FLT3-ITD. Gilteritinib is approved for the treatment of relpased/refractory FLT3-mutated AML after the successfull ADMIRAL trial. In the present study Gilteritinib (120 mg/die) in combination with FLAI will be tested as induction therapy in newly-diagnosed patients.
Complete remission rate after induction
Number of patients who achieve a CR after course 1 or course 2 if adiministered on the total of evaluable patients
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This trial is not recruiting at the moment. You can still explore other options:
