Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment

Sponsor
Technische Universität Dresden
Study ID
NCT06696183
Phase
PHASE2
Status
Recruiting
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Conditions

  • AML - Acute Myeloid Leukemia

Eligibility Criteria

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

Interventions

  • Gilteritinib (GILT) — DRUG
    80 mg
  • Venetoclax (VEN) — DRUG
    400 mg
  • Azacitidine (AZA) — DRUG
    75 mg/m²

Study Details

Explore the best tolerable and efficacious dose of Gilteritinib when combined with standard treatment with Venetoclax and Azacitidine in AML patients with FLT3 mutations which are ineligible for intensive chemotherapy

Key Dates

Start date
Apr 25, 2025
Status verified
May 2025
Primary completion
Apr 30, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    GILT d1-d28 VEN d1-d7 AZA d1-d7
  • Experimental: Cohort 2
    GILT d8-d28 VEN d1-d7 AZA d1-d7
  • Experimental: Cohort 3
    GILT d1-d28 VEN d1-d14 AZA d1-d7
  • Experimental: Cohort 4
    GILT d8-d28 VEN d1-d14 AZA d1-d7

Primary Outcome Measure

Ratio of dose delivered/dose planned [ Time Frame: 12 months ]

Central Contacts

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