Actively Recruiting
Sequential Gilteritinib with Venetoclax and Azacitidine for Newly Diagnosed 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the best tolerable and effective dose of Gilteritinib combined with standard treatments Venetoclax and Azacitidine in patients with newly diagnosed acute myeloid leukemia (AML) who have FLT3 mutations and cannot receive intensive chemotherapy. This Phase 2 trial focuses on patients ineligible for standard induction chemotherapy and aims to find the optimal dosing strategy for this combination. The study is led by Technische Universität Dresden and evaluates how well these treatments can be delivered together over time. Participants receive one of four treatment schedules combining Gilteritinib, Venetoclax, and Azacitidine in different sequences and durations. Gilteritinib is given at 80 mg, Venetoclax at 400 mg, and Azacitidine at 75 mg/m². The study groups vary by the days on which each drug is administered during a 28-day cycle, with Venetoclax given for either 7 or 14 days and Gilteritinib starting on day 1 or day 8. These schedules are designed to explore the best timing and dose combination for safety and effectiveness. During the study, participants are monitored for how much of the planned dose they receive over 12 months. Researchers assess treatment adherence and tolerability, tracking the ratio of dose delivered versus dose planned. The trial involves random assignment to one of the four treatment groups without masking. Participants undergo regular evaluations to monitor their health and response to treatment until the study ends in April 2030.
CONDITIONS
Brief 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 acute myeloid leukemia (AML) according to WHO 2022 or ICC 2022 with at least 20% bone marrow blasts, excluding acute promyelocytic leukemia (APL)
- Presence of FLT3 mutation at initial diagnosis
- Ineligibility for standard intensive induction chemotherapy
- Pre-treatment with one cycle of approved Venetoclax plus Azacitidine combination
You will not qualify if you...
- Relapsed or refractory AML
- Previous AML treatment 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 diagnosis of long QT Syndrome at screening
- Concurrent treatment with strong CYP3A inducers or St. John's wort
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days per cycle with repeated cycles as planned
Participants receive a combination of Gilteritinib, Venetoclax, and Azacitidine according to their assigned cohort schedule.
Multiple visits each cycle for treatment administration and monitoring
Trial Site Locations
Total: 1 location
1
Technische Universität Dresden
Dresden, Germany, 01307
Actively Recruiting
Research Team
P
Prof. Dr. Christoph Röllig, MD, MSc
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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