Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment
NCT06696183 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-05-29
Summary
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
Conditions
- AML - Acute Myeloid Leukemia
Interventions
- DRUG
-
Gilteritinib (GILT)
80 mg
- DRUG
-
Venetoclax (VEN)
400 mg
- DRUG
-
Azacitidine (AZA)
75 mg/m²
Sponsors & Collaborators
-
Technische Universität Dresden
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-25
- Primary Completion
- 2029-04-30
- Completion
- 2030-04-30
Countries
- Germany
Study Locations
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