About this trial
The FMS tyrosine kinase 3 (FLT3) gene mutation occurs in 30% of newly diagnosed AML patients, leading to a higher relapse rate and mortality rate. In the past, multi-drug combination chemotherapy regimens had limited efficacy in newly diagnosed AML patients with FLT3 mutations, especially in those with FLT3-ITD. However, the FLT3 inhibitors greatly improved the survival of AML patients with FLT3 mutations. Although several studies have focused on the effectiveness of FLT3 inhibitor combination therapy for FLT3-mutated AML, further studies are needed to determine the optimal regimen and dosage. A triple regimen consisting of Gilteritinib, Venetoclax, and Azacitidine had shown good efficacy in unfit newly diagnosed FLT3-mutated AML patients. This clinical trial aims to determine the optimal triple regimen and investigate its efficacy in newly diagnosed fit FLT3-mutated AML patients.
Eligibility criteria
Qualifiers
MDS/AML patients WHO meet AML and ICC definitions according to WHO (2022) or ICC standards (10%-20% of bone marrow naive cells) and have FLT3-TKD or ITD mutations detected by PCR or second-generation sequencing.
Age ≥15 years old, male or female.
The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
Disqualifiers
Acute promyelocytic leukemia with PML-RARA fusion gene
Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene
Acute myeloid leukemia with BCR-ABL fusion gene
Have treated patients (those who have previously received induction chemotherapy but can receive hydroxyurea down-cell therapy).
Trial design
Treatments tested in this trial
- Venetoclax
- Cytarabine
- Gilteritinib
- Azacitadine (AZA)