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Using Apixaban to Prevent Blood Clots in Children With Leukemia

Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia

Description:

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 Pegylated L-Asparaginase and have a central line (a catheter inserted for administration of medications and blood sampling).

Complete study information:  https://clinicaltrials.gov/ct2/show/NCT02369653

Who May Qualify?:
  • Patients with a new diagnosis of de novo ALL, lymphomas (T or B cell), or mixed-phenotype acute leukemia
  • Patients with a functioning Central Venous Access Device ( i.v. bag used to administer drugs through the vein)
  • Patients who are 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.
  • Patients with platelet Counts ≥ 20000/microL
Who Does Not Qualify:

Patients:

  • Scheduled to have > 3 Lumbar Punctures over the course of the treatment period ( often known to the public as “spinals”)
  • With prior history of documented DVT or PE in the past 3 months

  • With known inherited bleeding disorder or clotting disorder.

  • Who have had 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.

  • With uncontrolled severe hypertension at enrollment (high blood pressure). 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

  • With extreme hyper leukocytosis, white blood cell (WBC) counts over 200 x 109/L (200,000/microL) at the time of enrollment

  • With liver disease or liver dysfunction.

  • With history of significant adverse reaction or major bleeding related adverse reaction to other anticoagulant or antiplatelet agents

 

  • With history of any significant drug allergy. Any investigational drug being administered during the study
Interested in participating?
We are currently recruiting
Study Sponsor:

Bristol Myers - Squibb

Full IRB Study Title:
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 Pegylated (PEG) L-Asparaginase
IRB Study ID:
150408
If you are interested in this study or have questions about your child's eligibility, please contact:
Rebecca D. Considine Research Institute, 330-543-3193 or email research@akronchildrens.org
Lead Investigator
Steven Kuerbitz, MD

Director, Divisional Research and Stem Cell Transplantation; Pediatric Hematologist-Oncologist
Showers Family Center for Childhood Cancer and Blood DisordersPediatric Stem Cell Transplant Program