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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06561880
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • AML
  • FLT3 Gene Mutation

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Venetoclax dose and schedule determined by arms and treatment phases
  • Cytarabine — DRUG
    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 — DRUG
    Gilteritinib 120mg schedule determined by arms or treatment phases
  • Azacitadine (AZA) — DRUG
    Azacitidine 75mg/m2/d schedule determined by treatment phases

Study Details

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.

Key Dates

Start date
Oct 8, 2024
Status verified
May 2026
Primary completion
Sep 1, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Triple Regimen Induction of Arm1
    Patients will receive induction with a triple regimen therapy: Azacitidine 75mg/m2/d d1-7; Gilteritinib: 120mg d1-14; Venetoclax: 100mg d1, 200mg d2, 400mg d3-14
  • Experimental: Triple Regimen Induction of Arm2
    Patients will receive induction with a triple regimen therapy: Azacitidine 75mg/m2/d d1-7; Gilteritinib: 120mg d1-14; Venetoclax: 100mg d1, 200mg d2, 400mg d3-7
  • Experimental: Triple Regimen Induction of Arm3
    Patients will receive induction with a triple regimen therapy: Azacitidine 75mg/m2/d d1-7; Gilteritinib: 120mg d1-7; Venetoclax: 100mg d1, 200mg d2, 400mg d3-7

Primary Outcome Measure

Composite Complete remission (CRc) rate [ Time Frame: up to 3 months after the date of the last enrolled participants ]

Central Contacts

Related Studies