A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- New diagnosis of de novo ALL, lymphomas (T or B cell), or mixed-phenotype acute
leukemia

- Planned 3-4 drug systemic induction chemotherapy with a corticosteroid, vincristine
and a single dose or multiple doses of asparaginase, with or without daunorubicin

- Functioning Central Venous Access Device

- Must be 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.

Exclusion Criteria:

- Subjects scheduled to have > 3 Lumbar Punctures over the course of the study treatment
period

- Prior history of documented DVT or PE in the past 3 months

- Known inherited bleeding disorder or coagulopathy

- 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.

- Uncontrolled severe hypertension at enrollment. 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

- Extreme hyperleukocytosis, white blood cell (WBC) counts over 200 x 109/L
(200,000/microL) at the time of enrollment

- Liver dysfunction manifested by SGTP (ALT) > 5X Upper limit of normal (ULN) and/or
Aspartate aminotransferase (AST) >5 X ULN and/or direct (conjugated) bilirubin > 2X
ULN

- Renal function < 30% of normal for age and size as determined by the Schwartz formula

- International normalized ratio (INR) > 1.4 and activated partial thromboplastin time
(aPTT) > 3 seconds above the upper limit of normal for age, within 1 week prior to
enrollment.

- History of allergy to apixaban or Factor Xa inhibitors

- History of significant adverse reaction or major bleeding related adverse reaction to
other anticoagulant or antiplatelet agents

- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity

- Any investigational drug being administered during the study

Other protocol inclusion/exclusion criteria may apply