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

  • STATUS
    Recruiting
  • End date
    Nov 15, 2021
  • participants needed
    500
  • sponsor
    Bristol-Myers Squibb
Updated on 22 July 2021
corticosteroids
lymphoma
acute leukemia
vincristine
leukemia
daunorubicin
asparaginase
chemotherapy regimen

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)

Details
Condition childhood ALL, Lymphoma, Lymphoproliferative Disorder, Lymphoma, Non-Hodgkin's Lymphoma, Lymphocytic Leukemia, Acute, Lymphoproliferative disorders, acute lymphoblastic leukemia, leukemia, acute lymphoblastic, lymphomas, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all)
Treatment Apixaban, No systemic anticoagulant prophylaxis
Clinical Study IdentifierNCT02369653
SponsorBristol-Myers Squibb
Last Modified on22 July 2021

Eligibility

Yes No Not Sure

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
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