This phase 3 trial aims to evaluate the efficacy of gilteritinib as a maintenance therapy for acute myeloid leukemia (AML) patients to prevent cancer returning. The main outcomes to be investigated are relapse free survival and overall survival.
The details
Gilteritinib is a kinase inhibitor. It works by binding and inhibiting kinases to stop growth and survival signals being sent to cancer cells. It has been previously used in clinical trials for treating various types of cancer. It is thought that it may be a good option for AML patients in their first complete remission to prevent cancer returning.
The study will evaluate the effectiveness by looking at relapse free survival (time without cancer returning) and the overall survival (time until death from any cause).
Who are they looking for?
This study will recruit 354 patients who have FLT3/ITD AML and are in their first complete remission. Patients should be aged 18 and over to take part. Both males and females must agree to use contraception for the duration of the study.
Patients who are part of another trial will not be eligible. Those who have had a previous allogeneic stem cell transplant cannot take part. Patients with heart problems, low levels of potassium or magnesium in the blood, or central nervous system leukemia are not eligible. Also excluded are patients with HIV and/or hepatitis or uncontrolled infections.
How will it work
Patients will be randomly assigned to one of two groups. One group will receive gilteritinib once a day. The other will receive a placebo once a day. A placebo is a substance with no active effect. Both groups will receive treatment for up to 2 years.
The effectiveness will be measured by relapse free survival and overall survival. These will be measured by following up with patients for up to 61 months.
