RecruitingPhase 1Phase 2NCT06561880

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

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


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

66 participants

Start Date

Oct 8, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Azacitadine (AZA), a drug called Cytarabine, and others for people with aml and flt3 gene mutation. The study is currently recruiting participants at 1 location. People eligible for this study include aged 14 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

Venetoclax dose and schedule determined by arms and treatment phases

DRUGCytarabine

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.

DRUGGilteritinib

Gilteritinib 120mg schedule determined by arms or treatment phases

DRUGAzacitadine (AZA)

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


Locations(1)

Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

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NCT06561880


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