This trial aims to see the effect of a blood thinning drug apixaban (Eliquis) in preventing blood clots in children with leukemia or lymphoma who are receiving chemotherapy. The main outcome to be measured is the occurrence of any clotting problems or bleeding side effects.
The details
Patients with cancer are more at risk of blood clots, which can become life-threatening. Apixaban is a drug that prevents blood clots.
This study will examine whether apixaban could be effective in preventing blood clots in children with leukemia or lymphoma. The main outcome will be measured as the number of blood clots experienced.
Who are they looking for?
This study is recruiting 500 children with newly diagnosed leukemia or lymphoma. Treatment with chemotherapy, which includes pegylated L-asparaginase (chemotherapy drug), should be planned. They should have a central line (catheter) inserted for giving medications and taking blood. They should be able to tolerate oral medications.
Children should not be expecting to have more than 3 lumbar punctures over the course of the treatment. They should not have a previous deep vein thrombosis or pulmonary embolism in the past 3 months. They should not have any known bleeding or clotting disorder. They should not have severe uncontrolled high blood pressure. They should not have a history of severe allergic reaction.
How will it work
Children will be randomly assigned to one of 2 treatment groups. Children in the first treatment group will receive apixaban for 25-28 days. Children in the second treatment group will not receive apixaban. These children will also be started on chemotherapy. Over 1 month, the occurrence of any clotting complications such as a deep vein thrombosis or bleeding events will be recorded.
