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
Condition: Lymphoma; Acute Lymphoblastic Leukemia
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Apixaban; No systemic anticoagulant prophylaxis
Intervention MeSH terms: Apixaban; Anticoagulants
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 512.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Anticoagulation

Summary:

      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)
    

Eligibility criteria:

        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