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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: 9 July, 2021   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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Use the Study Participant's 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)

  • 79

    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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com