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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Newly diagnosed AML (according to WHO 2022 or ICC 2022 criteria) with a minimum BM blast count of \>=20%, excluding APL
• FLT3 mutation at initial diagnosis
• Ineligibility of standard induction chemotherapy
• Pre-treatment with approved combination of Venetoclax + Azacitidine (one cycle only)
Locations
Other Locations
Germany
Technische Universität Dresden
RECRUITING
Dresden
Contact Information
Primary
Prof. Dr. Christoph Röllig, MD, MSc
sequence@ukdd.de
+49 351 458 4190
Time Frame
Start Date: 2025-04-25
Estimated Completion Date: 2030-04
Participants
Target number of participants: 60
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Technische Universität Dresden