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RECRUITING
NCT06561880
PHASE1/PHASE2

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

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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.

Official title: The Efficacy of a Triple Regimen Including Gilteritinib, Venetoclax, and Azacitidine in Newly Diagnosed Fit AML Patients With FLT3 Mutation

Key Details

Gender

All

Age Range

14 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2024-10-08

Completion Date

2027-08-31

Last Updated

2026-05-13

Healthy Volunteers

No

Interventions

DRUG

Venetoclax

Venetoclax dose and schedule determined by arms and treatment phases

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

Gilteritinib 120mg schedule determined by arms or treatment phases

DRUG

Azacitadine (AZA)

Azacitidine 75mg/m2/d schedule determined by treatment phases

Locations (1)

Blood Diseases Hospital

Tianjin, Tianjin Municipality, China