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
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 17
Updated:1/5/2019
Start Date:April 9, 2015
End Date:May 28, 2020
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email:Clinical.Trials@bms.com

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A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention Versus No Systemic Anticoagulant Prophylaxis During Induction Chemotherapy in Children With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoma (T or B Cell) Treated With Asparaginase

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)


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

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
We found this trial at
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Phoenix, Arizona 85016
Phone: 602-546-0188
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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Phone: 330-543-8731
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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4900 Mueller Boulevard
Austin, Texas 78723
(512) 324-0000
Phone: 512-628-1902
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Phone: 410-955-0432
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Phone: 716-845-4561
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Phone: 614-722-3694
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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1200 Pleasant Street
Des Moines, Iowa 50309
(515) 241-KIDS
Phone: 515-241-8912
Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Phone: 860-545-9614
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Phone: 601-984-5220
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Phone: 904-697-2508
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Phone: 850-505-4794
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 215-590-2801
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Phone: 412-692-7476
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
Phone: 914-594-2132
New York Medical College The College was founded in 1860 by a group of New...
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Albany, New York 12208
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Ann Arbor, Michigan 48109
Phone: 734-763-6344
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1405 Clifton Road
Atlanta, Georgia 30322
Phone: 404-785-4746
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Phone: 410-601-8393
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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2545 Schoenersville Road
Bethlehem, Pennsylvania 18017
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Boise, Idaho 83712
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Bronx, New York 10467
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Chapel Hill, North Carolina 27599
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Cincinnati, Ohio 45219
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Cleveland, Ohio 44106
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6300 Ocean Drive
Corpus Christi, Texas 78412
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Phone: 570-271-6896
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Detroit, Michigan 48201
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Fort Myers, Florida 33908
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Phone: 201-487-8987
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Hershey, Pennsylvania 17033
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200 Hawkins Dr,
Iowa City, Iowa 52242
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
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Minneapolis, Minnesota 55404
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2200 Children's Way
Nashville, Tennessee 37232
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New Brunswick, New Jersey 08903
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New Lambton Heights, New South Wales 2305
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
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Richmond, Virginia 23219
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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601 Elmwood Avenue
Rochester, New York 14642
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501 6th Avenue South
Saint Petersburg, Florida 33701
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San Antonio, Texas 78229
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Wilmington, Delaware 19803
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Winston-Salem, North Carolina 27157
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