Clinical Trial

Gilteritinib-Azacitidine-Venetoclax Combination Therapy in Patients With Relapsed/Refractory Leukemia

Study acronym: GAVE001
Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn if gilteritinib-azacitidine-venetoclax combination drug therapy works to treat adults with FLT3-wt acute myeloid leukemia (AML). It will also learn about the safety and efficacy of this treatment. The main question this clinical trial aims to answer are: * Will adding gilteritinib to standard-of-care therapy azacitidine-venetoclax show be more effective in treating AML FLT3-wt patients who have previously been treated with azacitidine and/or venetoclax for their disease and have had their cancer come back (relapsed) or have stopped responding to treatment (refractory)? All participants in this trial will receive the combination therapy. Participants will be on repeated 28-day cycles, for a minimum of 2 cycles, while on the study Participants will: * Take the gilteritinib once daily, every day * Take azacitidine and venetoclax on days 1-7 of each cycle * Keep a daily dose diary of the days and times they have taken their treatments * Visit the clinic every 4 weeks for checkups and tests
Trial Details
NCT Number NCT07755202
Lead Sponsor Florian Kuchenbauer
Conditions Acute Myeloid Leukemia, AML With FLT3 Mutation
Enrollment 20 participants
Start Date 2026-09-01
Primary Completion 2029-10-01 (estimated)
Study Completion 2030-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-10