Apixaban to Prevent Blood Clots in Children With Leukemia

• Patients with a new diagnosis of de novo ALL, lymphomas (T or B cell), or mixed-phenotype acute leukemia
• Patients with a functioning Central Venous Access Device ( i.v. bag used to administer drugs through the vein)
• Patients who are able to tolerate oral medication or have it administered via an Nasogastric tube (NGT) or GT tube
• Males and females, age 1 year (365 days) to < 18 (17 years and 364 days) years.
• Patients with platelet Counts ≥ 20000/microL

Patients:

• Scheduled to have > 3 Lumbar Punctures over the course of the treatment period ( often known to the public as “spinals”)

• 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

• With history of any significant drug allergy. Any investigational drug being administered during the study

Bristol Myers - Squibb