NCT06696183

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

Sequential Gilteritinib in Combination With Venetoclax and Azacitidine for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and FLT3 Mutations Ineligible for Intensive Treatment

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Gilteritinib (GILT)	80 mg
DRUG	Venetoclax (VEN)	400 mg
DRUG	Azacitidine (AZA)	75 mg/m²

Timeline

• Start date: 2025-04-25
• Primary completion: 2029-04-01
• Completion: 2030-04-01
• First posted: 2024-11-20
• Last updated: 2025-05-29

Locations

1 site across 1 country: Germany