The purpose of this study is to compare the effect of a blood thinning drug called Apixaban versus no administration of a blood thinning drug, in preventing blood clots in children with leukemia or lymphoma. Patients must be receiving chemotherapy; including Pegylated L-Asparaginase and have a central line (a catheter inserted for administration of medications and blood sampling).
Complete study information: https://clinicaltrials.gov/ct2/show/NCT02369653
Patients:
With prior history of documented DVT or PE in the past 3 months
With known inherited bleeding disorder or clotting disorder.
Who have had major surgery [excluding Central Venous Access Device (CVAD) replacement and bone marrow aspiration and non-open biopsy] within the last 7 days prior to enrollment that may be associated with a risk of bleeding. Open biopsy is considered a major surgery.
With uncontrolled severe hypertension at enrollment (high blood pressure). Severe hypertension is defined as a systolic or diastolic blood pressure (BP) > 5 mm Hg above the 95th percentile as defined by the National High Blood Pressure Education Program Working Group (NHBPEP) established guidelines for the definition of normal and elevated blood pressure in children
With extreme hyper leukocytosis, white blood cell (WBC) counts over 200 x 109/L (200,000/microL) at the time of enrollment
With liver disease or liver dysfunction.
With history of significant adverse reaction or major bleeding related adverse reaction to other anticoagulant or antiplatelet agents
Bristol Myers - Squibb
Director, Divisional Research, Stem Cell Transplantation & Shannon E. Wilkes Targeted Therapy Program; The Jeffrey A. Barbour Chair for Pediatric Hematology Oncology Research and Healing; Pediatric Hematologist-Oncologist
Showers Family Center for Childhood Cancer and Blood DisordersPediatric Stem Cell Transplant Program