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Recruiting

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 - CV185-155

Updated: 13 August, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
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Use the trial guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 69

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Apixaban
Drug: Apixaban
Placebo Comparator: No systemic anticoagulant prophylaxis
Other: No systemic anticoagulant prophylaxis

Key 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

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us