Actively Recruiting
Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment
Led by Technische Universität Dresden · Updated on 2025-05-29
60
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed AML with at least 20% bone marrow blast count, excluding acute promyelocytic leukemia (APL)
- Presence of FLT3 mutation at initial diagnosis
- Ineligible for standard intensive induction chemotherapy
- Completed one cycle of Venetoclax plus Azacitidine prior to study enrollment
You will not qualify if you...
- Relapsed or refractory AML
- Previous treatments for AML except hydroxyurea or one cycle of Venetoclax plus Azacitidine
- Prior treatment with Gilteritinib
- Known active central nervous system involvement
- QTcF interval greater than 450 ms or long QT Syndrome at screening
- Use of strong CYP3A inducers or St. John's wort during treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Technische Universität Dresden
Dresden, Germany, 01307
Actively Recruiting
Research Team
P
Prof. Dr. Christoph Röllig, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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