A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention Versus No Systemic Anticoagulant Prophylaxis During Induction Chemotherapy in Children With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoma (T or B Cell) Treated With Asparaginase
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 asparaginase, and have a central line (a catheter inserted for administration of medications and blood sampling).
- 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.
- 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
KeywordsApixaban, Blood thinning drugs, Asparaginase
Principal InvestigatorWilliam Slayton, M.D.
Sponsoring GroupDepartment of Pediatrics
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