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

Completed · Phase 3

Conditions studied: Lymphoma, Acute Lymphoblastic Leukemia

In brief

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)

Key facts

Study ID

NCT02369653

Run by

Bristol-Myers Squibb

People needed

512

Starts

2015-10-22

Expected to finish

2021-07-07

Last updated by the study team

2022-03-08

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 qualify 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
• Other protocol inclusion/exclusion criteria may apply

Where it is running

• City of Hope — Duarte, California, United States
• Loma Linda University Cancer Center — Loma Linda, California, United States
• Childrens Hospital Of La — Los Angeles, California, United States
• Children'S Hospital Of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital (LPCH) — Palo Alto, California, United States
• Rady Children'S Hospital - San Diego — San Diego, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Nemours / A. I. duPont Hospital for Children — Wilmington, Delaware, United States
• Golisano Childrens Hospital of Southwest Florida — Fort Myers, Florida, United States
• Shands Hospital At University Of Florida — Gainesville, Florida, United States
• Nemours Children'S Clinic — Jacksonville, Florida, United States
• Nemours Children'S Clinic - Orlando — Orlando, Florida, United States
• Nemours Children'S Clinic-Pensacola — Pensacola, Florida, United States
• All Childrens Hospital Specialty Physicians — St. Petersburg, Florida, United States
• St. Marys Medical Center — West Palm Beach, Florida, United States
• Childrens Healthcare Of Atlanta - E — Atlanta, Georgia, United States
• Navicent Health Physician Group — Macon, Georgia, United States
• St. Luke'S Mountain State Tumor Institute — Boise, Idaho, United States
• Children'S Center For Cancer And Blood Diseases — Indianapolis, Indiana, United States
• Blank Childrens Hospital — Des Moines, Iowa, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• University Of Louisville — Louisville, Kentucky, United States
• Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr. — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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