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Brief 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 Asparaginase
Official Title: 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
Study ID: NCT02369653
Brief 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)
Detailed Description:
Minimum Age: 1 Year
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr., Phoenix, Arizona, United States
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, Saint 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
Childrens Hospital New Orleans, New Orleans, Louisiana, United States
Ochsner Medical Center, New Orleans, Louisiana, United States
Sinai Hospital Of Baltimore, Baltimore, Maryland, United States
Johns Hopkins University, Baltimore, Maryland, United States
University Of Michigan Cancer Center, Ann Arbor, Michigan, United States
Childrens Hospitals And Clinics Of Minnesota, Minneapolis, Minnesota, United States
University Of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
University Of Mississippi Medical Center, Jackson, Mississippi, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Valerie Fund Children's Center at St. Joseph's Children's Hospital, Paterson, New Jersey, United States
Albany Medical Center, Albany, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
University Of Rochester General Clinical Research Center, Rochester, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
New York Medical College, Valhalla, New York, United States
Unv. Of Nc At Chapel Hill, Chapel Hill, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
Akron Children'S Hospital, Akron, Ohio, United States
Cincinnati Children'S Hospital Medical Center, Cincinnati, Ohio, United States
University Hospitals, Cleveland, Ohio, United States
Nationwide Children'S Hospital, Columbus, Ohio, United States
Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
Childrens Hospital Of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital Of Pittsburgh Of UPMC, Pittsburgh, Pennsylvania, United States
Children's Hospital at TriStar Centennial, Nashville, Tennessee, United States
Monroe Carell Jr Children'S Hosp. At Vanderbilt Tower, Nashville, Tennessee, United States
Dell Children'S Medical Center Of Central Texas, Austin, Texas, United States
Driscoll Children'S Hospital, Corpus Christi, Texas, United States
Texas Children's Cancer and Hematology Centers, Houston, Texas, United States
Children's Hospital of San Antonio, San Antonio, Texas, United States
University Hospital, San Antonio, Texas, United States
Scott & White - McLane Children's Specialty Clinic, Temple, Texas, United States
Providence Sacred Heart Medical Center, Spokane, Washington, United States
MultiCare Institute for Research & Innovation, Tacoma, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Local Institution, New Lambton Heights, New South Wales, Australia
Queensland Children's Hospital, Sth Brisbane, Queensland, Australia
Monash Medical Centre Clayton, Clayton, Victoria, Australia
Local Institution, Parkville, Victoria, Australia
Local Institution, Bruxelles, , Belgium
Local Institution, Bruxelles, , Belgium
Local Institution, Edegem, , Belgium
Local Institution, Gent, , Belgium
Local Institution, Leuven, , Belgium
Alberta Children'S Hospital, Calgary, Alberta, Canada
Local Institution, Edmonton, Alberta, Canada
Local Institution, St, John's, Newfoundland and Labrador, Canada
Children'S Hospital London Health Sciences Centre, London, Ontario, Canada
Children'S Hospital Of Eastern Ontario, Ottawa, Ontario, Canada
Klinika detske onkologie, Brno, , Czechia
Local Institution, Budapest, , Hungary
Local Institution, Debrecen, , Hungary
Local Institution, Pecs, , Hungary
Local Institution, Seoul, , Korea, Republic of
Local Institution, Seoul, , Korea, Republic of
Local Institution, Df, Distrito Federal, Mexico
Local Institution, Guadalajara, Jalisco, Mexico
Local Institution, Monterrey, Nuevo Leon, Mexico
Local Institution, Christchurch, , New Zealand
Klinika Transplantacji Szpiku Onkologii i Hematologii Dzieciecej, Wroclaw, , Poland
Oddzial Hematologii i Onkologii Dzieciecej, Zabrze, , Poland
Local Institution, Caguas, , Puerto Rico
Local Institution, Kirov, , Russian Federation
Local Institution, Moscow, , Russian Federation
Local Institution, Moscow, , Russian Federation
Local Institution, Saint Petersburg, , Russian Federation
Local Institution, St.petersburg, , Russian Federation
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR