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
NCT02369653
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Lexington, Kentucky
- Syracuse, New York
- Brno,
- Zabrze,
- Saint-Petersburg,
- Phoenix, Arizona
- Duarte, California
- Loma Linda, California
- Los Angeles, California
- Orange, California
- San Diego, California
- Hartford, Connecticut
- New Haven, Connecticut
- Wilmington, Delaware
- Washington, District of Columbia
- Gainesville, Florida
- Jacksonville, Florida
- Orlando, Florida
- Pensacola, Florida
- Saint Petersburg, Florida
- Atlanta, Georgia
- Boise, Idaho
- Indianapolis, Indiana
- Des Moines, Iowa
- Iowa City, Iowa
- Louisville, Kentucky
- New Orleans, Louisiana
- New Orleans, Louisiana
- Brewer, Maine
- Baltimore, Maryland
- Baltimore, Maryland
- Ann Arbor, Michigan
- Minneapolis, Minnesota
- Rochester, Minnesota
- Jackson, Mississippi
- Hackensack, New Jersey
- New Brunswick, New Jersey
- Paterson, New Jersey
- Albany, New York
- Bronx, New York
- Buffalo, New York
- Rochester, New York
- Valhalla, New York
- Chapel Hill, North Carolina
- Winston-Salem, North Carolina
- Akron, Ohio
- Cincinnati, Ohio
- Cleveland, Ohio
- Cleveland, Ohio
- Columbus, Ohio
- Bethlehem, Pennsylvania
- Danville, Pennsylvania
- Hershey, Pennsylvania
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- Nashville, Tennessee
- Austin, Texas
- Corpus Christi, Texas
- Houston, Texas
- San Antonio, Texas
- San Antonio, Texas
- Spokane, Washington
- Tacoma, Washington
- Milwaukee, Wisconsin
- Bruxelles,
- Bruxelles,
- Edegem,
- Gent,
- Leuven,
- Edmonton, Alberta
- St. John's, Newfoundland and Labrador
- London, Ontario
- Ottawa, Ontario
- Calgary,
- Budapest,
- Budapest,
- Debrecen,
- Pecs,
- Seoul,
- Seoul,
- Df, Distrito Federal
- Mexico City, Distrito Federal
- Guadalajara, Jalisco
- Monterrey, Nuevo LEON
- Christchurch,
- Lublin,
- Wroclaw,
- Caguas,
- Kirov,
- Moscow,
- Moscow,
- St.petersburg,
Descriptive Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
Brief Title ICMJE | 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 ICMJE | 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 | ||||||||
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 | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | ||||||||
Condition ICMJE |
| ||||||||
Intervention ICMJE |
| ||||||||
Study Arms ICMJE |
| ||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 500 | ||||||||
Original Estimated Enrollment ICMJE | 700 | ||||||||
Estimated Study Completion Date ICMJE | November 15, 2021 | ||||||||
Estimated Primary Completion Date | November 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria:
Exclusion Criteria:
Other protocol inclusion/exclusion criteria may apply | ||||||||
Sex/Gender ICMJE |
| ||||||||
Ages ICMJE | 1 Year to 17 Years (Child) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
| ||||||||
Listed Location Countries ICMJE | Australia, Belgium, Brazil, Canada, Czechia, Hungary, Korea, Republic of, Mexico, New Zealand, Poland, Puerto Rico, Russian Federation, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT02369653 | ||||||||
Other Study ID Numbers ICMJE | CV185-155 2014-000328-47 ( EudraCT Number ) | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
| ||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Bristol-Myers Squibb | ||||||||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||||||||
Collaborators ICMJE | Pfizer | ||||||||
Investigators ICMJE |
| ||||||||
PRS Account | Bristol-Myers Squibb | ||||||||
Verification Date | October 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |