The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation
NCT Number: NCT06561880
Acronym: FLT3AML-2024
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: FLT3 Gene Mutation|AML
Interventions: DRUG: Gilteritinib|DRUG: Cytarabine|DRUG: Gilteritinib
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-08-31

Summary:
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 dosage of the triple regimen and investigate its efficacy in newly diagnosed fit FLT3-mutated AML patients. Besides, this trial will provide evidence for treatment decisions based on measurable residual disease in patients with the triple regimen.

Primary Outcome Measures: To determine the maximum tolerated dose of gilteritinib, The maximum dose of gilteritinib that can be safely combined with azacitidine and venetoclax, up to 3 months after enrollment of the first participants|Event-free survival (EFS), The interval from the date of enrollment to the date of failed to achieve complete remission, the date of relapse, or the date of death, whichever occurred first., up to 2 years after the date of the last enrolled participants|Complete remission (CR)/CR with partial hematologic recovery (CRh)/CR with incomplete hematologic recovery (CRi) with negative MRD detected by flow cytometry., The ratio of CR/CRh/CRi with negative MRD detected by flow cytometry after induction, consolidation, and maintenance therapy., up to 1 years after the date of the last enrolled participants|CR/CRh/CRi with negative MRD detected by NGS (next-generation sequencing), The ratio of CR/CRh/CRi with negative MRD detected by NGS after induction,consolidation, and maintenance therapy., up to 1 years after the date of the last enrolled participants
Secondary Outcome Measures: CR/CRh/CRi rate, The ratio of patients achieved CR/CRh/CRi after two course of induction therapy, up to 3 months after the date of the last enrolled participants|overall survival, The interval from the date of enrollment to the date of death or the date of last follow-up, , whichever occurred first., up to 2 years after the date of the last enrolled participants|Relapse free survival, The interval from CR to the date of relapse, or the date of death, or the date of last follow-up, whichever occurred first. This outcome analyzes patients achieved CR in two courses of induction therapy., up to 2 years after the date of the last enrolled participants|30-day mortality, Percentage of patients who died within 30 days from enrollment, Within 30 days of the date of the last enrolled participants|60-day mortality, Percentage of patients who died within 60 days from enrollment, Within 60 days of the date of the last enrolled participants