Clareo Health | 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
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
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Keep this study
Lead
Bristol-Myers Squibb
With
Pfizer
Age
1–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
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.
You may not be if
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
