The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation

Condition(s) studied

Investigational drug(s) / intervention(s)

Venetoclax: Venetoclax dose and schedule determined by arms and treatment phases

Cytarabine: Consolidation therapy (3 courses): intermediate-dose cytarabine regimen :2g/m2 q12h d1-3, age \< 60 years;1g/m2 q12h d1-3, age ≥60 years. If NGS detected FLT3 mutation before consolidation chemotherapy, gilteritinib will be added during the consolidation course at d4-17.

Gilteritinib: Gilteritinib 120mg schedule determined by arms or treatment phases

Azacitadine (AZA): Azacitidine 75mg/m2/d schedule determined by treatment phases

Study 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 triple regimen and investigate its efficacy in newly diagnosed fit FLT3-mutated AML patients.

Eligibility

Primary outcome measure(s)

• Composite Complete remission (CRc) rate — up to 3 months after the date of the last enrolled participants
  The ratio of patients achieved CRc（CR/CRh/CRi) after induction therapy
• Composite Complete remission (CRc) with negative MRD detected by flow cytometry. — up to 1 years after the date of the last enrolled participants
  The ratio of CRc with negative MRD detected by flow cytometry after induction, consolidation, and maintenance therapy.
• To determine the tolerated dose of triple regimens — up to 3 months after enrollment of the first participants
  The dose of gilteritinib and venetoclax that can be safely combined with azacitidine
• Event-free survival (EFS) — up to 2 years after the date of the last enrolled participants
  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.

Trial sites (1)

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