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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

October 8, 2024

Primary Completion Date

September 1, 2026

Study Completion Date

August 31, 2027

Conditions
FLT3 Gene MutationAML
Interventions
DRUG

Gilteritinib

"Induction therapy regimen(2 courses):~triple regimen therapy: Azacitidine 75mg/m2/d d1-7; Venetoclax 100mg d1,200mg d2,400mg d3-28; Gilteritinib (as required at admission: 80 or 120mg) d1-28.~dose-adjusted triple regimen therapy: Azacitidine 75mg/m2/d d1-5; Venetoclax 400mg d1-7; Gilteritinib (as required at admission: 80 or 120mg) d1-28.~Patients with no remission after the first induction course will receive another course with triple regimen therapy; Patients with complete remission after the first induction course will receive another course of dose-adjusted triple regimen therapy."

DRUG

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."

DRUG

Gilteritinib

"Maintenance treatment (6 courses):~dose-adjusted triple regimen therapy:Azacitidine 75mg/m2/d d1-5; Venetoclax 400mg d1-7; Gilteritinib (as required at admission: 80 or 120mg) d1-28."

Trial Locations (1)

300020

RECRUITING

Blood Diseases Hospital, Tianjin

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER