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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
Active
Cancer Type
Leukemia
Non-Hodgkin Lymphoma
Trial Phase
Phase III
Eligibility
1 - 17 Years, Male and Female
Study Type
Prevention
NCT ID
NCT02369653
Protocol IDs
CV185-155 (primary)
NCI-2015-01370
2014-000328-47
Study Sponsor
Bristol-Myers Squibb

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)

Eligibility

  1. New diagnosis of de novo ALL, lymphomas (T or B cell), or mixed-phenotype acute leukemia
  2. Planned 3-4 drug systemic induction chemotherapy with a corticosteroid, vincristine and a single dose or multiple doses of asparaginase, with or without daunorubicin
  3. Functioning Central Venous Access Device
  4. Must be able to tolerate oral medication or have it administered via an Nasogastric tube (NGT) or GT tube
  5. Males and females,age 1 year(365 days) to < 18 (17 years and 364 days) years.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston


1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.