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

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

Timeline

Start

2026-09-01

Primary completion

2029-10-01

Completion

2030-05-01

Drugs

Indications