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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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

  • Clinicaltrials.gov identifier

    NCT02369653

  • Recruitment Status

    Recruiting

  • First Posted

    February 24, 2015

  • Last update posted

    July 13, 2021

Study Description

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)

  • Condition or Disease:Acute Lymphoblastic Leukemia
    Lymphoma
  • Intervention/Treatment: Drug: Apixaban
    Other: No systemic anticoagulant prophylaxis
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 500 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Prevention
  • 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
  • Actual Study Start Date: April 2015
  • Estimated Primary Completion Date: November 2021
  • Estimated Study Completion Date: November 2021

Arms and interventions

Arm Intervention/treatment
Experimental: Apixaban
Children aged 1 to <18 years weighing 6 to <35 kg randomized to apixaban will receive a fixed dose apixaban based on body weight tier twice a day for approximately 28 days. Children aged 1 to <18 years weighing ≥ 35 kg will receive 2.5 mg of apixaban twice a day for approximately 28 days. Subjects ≥ 5 years may be administered either 2.5-mg, 0.5-mg tablets or oral solution apixaban. Subjects < 5years and < 35 kg may be administered 0.5-mg tablets only
Drug: Apixaban
Placebo Comparator: No systemic anticoagulant prophylaxis
No systemic anticoagulant prophylaxis
Other: No systemic anticoagulant prophylaxis

Outcome Measures

  • Primary Outcome Measures: 1. Efficacy: A composite of adjudicated non-fatal deep vein thrombosis (DVT, including asymptomatic and symptomatic), pulmonary embolism (PE), and cerebral venous sinus thrombosis (CSVT) and venous thromboembolism (VTE)-related-death [ Time Frame: Up to 1 month ]
    Objectively confirmed by independent adjudication
  • 2. Safety: Adjudicated major bleeding using the International Society on Thrombosis and Haemostasis (ISTH) definition for children [ Time Frame: Up to 1 month ]
  • Secondary Outcome Measures: 1. Efficacy: a) Non-fatal asymptomatic DVT [ Time Frame: Up to 1 month ]
  • 2. Efficacy: b) Non-fatal symptomatic DVT [ Time Frame: Up to 1 month ]
  • 3. Efficacy: c) Non-fatal PE [ Time Frame: Up to 1 month ]
  • 4. Efficacy: d) CSVT [ Time Frame: Up to 1 month ]
  • 5. Efficacy: e) VTE-related-death [ Time Frame: Up to 1 month ]
  • 6. Safety: Composite of major and clinically relevant non major bleeding (CRNMB) using the ISTH definition for children [ Time Frame: Up to 1 month ]
  • 7. Pharmacodynamics: Anti-FXa Activity measured by plasma concentration assay [ Time Frame: Up to 1 month ]
  • 8. Pharmacokinetics: Measured by maximum observed concentration (Cmax) [ Time Frame: Up to 1 month ]
  • 9. Pharmacokinetics: Measured by trough observed concentration (Cmin) [ Time Frame: Up to 1 month ]
  • 10. Pharmacokinetics: Measured by area under the concentration-time curve in one dosing interval [AUC(TAU)] [ Time Frame: Up to 1 month ]

Eligibility Criteria

  • Ages Eligible for Study: 1 to 17 Year (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT# and Site #.

Locations

United States, Arizona
Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr.
Phoenix

United States, California
City of Hope
Duarte

United States, California
Loma Linda University Cancer Center
Loma Linda

United States, California
Childrens Hospital Of La
Los Angeles

United States, California
Local Institution
Los Angeles

United States, California
Local Institution
Orange

United States, California
Lucile Packard Children's Hospital (LPCH)
Palo Alto

United States, California
Rady Children'S Hospital - San Diego
San Diego

United States, Connecticut
Connecticut Children's Medical Center
Hartford

United States, Connecticut
Yale University School Of Medicine
New Haven

United States, Delaware
Nemours / A. I. duPont Hospital for Children
Wilmington

United States, District of Columbia
Local Institution
Washington

United States, Florida
Golisano Childrens Hospital of Southwest Florida
Fort Myers

United States, Florida
Shands Hospital At University Of Florida
Gainesville

United States, Florida
Nemours Children'S Clinic
Jacksonville

United States, Florida
Nemours Children'S Clinic - Orlando
Orlando

United States, Florida
Nemours Children'S Clinic-Pensacola
Pensacola

United States, Florida
Local Institution
Saint Petersburg

United States, Florida
Local Institution
Tampa

United States, Florida
St. Marys Medical Center
West Palm Beach

United States, Georgia
Childrens Healthcare Of Atlanta - E
Atlanta

United States, Georgia
Navicent Health Physician Group
Macon

United States, Idaho
St. Luke'S Mountain State Tumor Institute
Boise

United States, Illinois
Local Institution
Chicago

United States, Indiana
Children'S Center For Cancer And Blood Diseases
Indianapolis

United States, Iowa
Blank Childrens Hospital
Des Moines

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City

United States, Kentucky
University of Kentucky
Lexington

United States, Kentucky
University Of Louisville
Louisville

United States, Louisiana
Childrens Hospital New Orleans
New Orleans

United States, Louisiana
Ochsner Medical Center
New Orleans

United States, Maine
Local Institution
Brewer

United States, Maryland
Sinai Hospital Of Baltimore
Baltimore

United States, Maryland
Johns Hopkins University
Baltimore

United States, Michigan
University Of Michigan Cancer Center
Ann Arbor

United States, Michigan
Local Institution
Detroit

United States, Minnesota
Childrens Hospitals And Clinics Of Minnesota
Minneapolis

United States, Minnesota
University Of Minnesota
Minneapolis

United States, Minnesota
Mayo Clinic Rochester
Rochester

United States, Mississippi
University Of Mississippi Medical Center
Jackson

United States, Montana
Local Institution
Kalispell

United States, New Jersey
Hackensack University Medical Center
Hackensack

United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick

United States, New Jersey
Valerie Fund Children's Center at St. Joseph's Children's Hospital
Paterson

United States, New York
Local Institution
Albany

United States, New York
Local Institution
Bronx

United States, New York
Roswell Park Cancer Institute
Buffalo

United States, New York
University Of Rochester General Clinical Research Center
Rochester

United States, New York
SUNY Upstate Medical University
Syracuse

United States, New York
New York Medical College
Valhalla

United States, North Carolina
Unv. Of Nc At Chapel Hill
Chapel Hill

United States, North Carolina
Wake Forest Baptist Health
Winston-Salem

United States, Ohio
Akron Children'S Hospital
Akron

United States, Ohio
Cincinnati Children'S Hospital Medical Center
Cincinnati

United States, Ohio
University Hospitals
Cleveland

United States, Ohio
Local Institution
Cleveland

United States, Ohio
Nationwide Children'S Hospital
Columbus

United States, Oregon
Local Institution
Portland

United States, Pennsylvania
Lehigh Valley Hospital - Muhlenberg
Bethlehem

United States, Pennsylvania
Geisinger Medical Center
Danville

United States, Pennsylvania
Penn State Hershey Medical Center
Hershey

United States, Pennsylvania
Childrens Hospital Of Philadelphia
Philadelphia

United States, Pennsylvania
Children's Hospital Of Pittsburgh Of UPMC
Pittsburgh

United States, Tennessee
Children's Hospital at TriStar Centennial
Nashville

United States, Tennessee
Monroe Carell Jr Children'S Hosp. At Vanderbilt Tower
Nashville

United States, Texas
Dell Children'S Medical Center Of Central Texas
Austin

United States, Texas
Driscoll Children'S Hospital
Corpus Christi

United States, Texas
Texas Children's Cancer and Hematology Centers
Houston

United States, Texas
Children's Hospital of San Antonio
San Antonio

United States, Texas
Local Institution
San Antonio

United States, Texas
University Hospital
San Antonio

United States, Texas
Scott & White - McLane Children's Specialty Clinic
Temple

United States, Virginia
Local Institution
Richmond

United States, Washington
Providence Sacred Heart Medical Center
Spokane

United States, Washington
Local Institution
Tacoma

United States, West Virginia
Local Institution
Morgantown

United States, Wisconsin
Medical College Of Wisconsin
Milwaukee

Australia, New South Wales
Local Institution
New Lambton Heights

Australia, Queensland
Queensland Children's Hospital
Sth Brisbane

Australia, Victoria
Monash Medical Centre Clayton
Clayton

Australia, Victoria
Local Institution
Parkville

Belgium
Local Institution
Bruxelles

Belgium
Local Institution
Bruxelles

Belgium
Local Institution
Edegem

Belgium
Local Institution
Gent

Belgium
Local Institution
Leuven

Brazil, Minas Gerais
Local Institution
Belo Horizonte

Brazil, Parana
Local Institution
Cascavel

Brazil, Parana
Local Institution
Curitiba

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, SAO Paulo
Local Institution
Ribeirao Preto

Brazil, SAO Paulo
Local Institution
S?o Paulo

Brazil
Local Institution
Sao Paulo

Brazil
Local Institution
Sao Paulo

Canada, Alberta
Alberta Children'S Hospital
Calgary

Canada, Alberta
Local Institution
Edmonton

Canada, Newfoundland and Labrador
Local Institution
St, John's

Canada, Ontario
Children'S Hospital London Health Sciences Centre
London

Canada, Ontario
Children'S Hospital Of Eastern Ontario
Ottawa

Czechia
Klinika detske onkologie
Brno

Hungary
Local Institution
Budapest

Hungary
Local Institution
Budapest

Hungary
Local Institution
Debrecen

Hungary
Local Institution
Pecs

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Mexico, Distrito Federal
Local Institution
Df

Mexico, Distrito Federal
Local Institution
Mexico City

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Nuevo Leon
Local Institution
Monterrey

New Zealand
Local Institution
Christchurch

Poland
Local Institution
Lublin

Poland
Klinika Transplantacji Szpiku Onkologii i Hematologii Dzieciecej
Wroclaw

Poland
Oddzial Hematologii i Onkologii Dzieciecej
Zabrze

Puerto Rico
Local Institution
Caguas

Russian Federation
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

Sponsors and Collaborators

Bristol-Myers Squibb

Pfizer

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT02369653 History of Changes
  • Other Study ID Numbers: CV185-155, 2014-000328-47
  • First Posted: February 24, 2015 Key Record Dates
  • Last Update Posted: July 13, 2021
  • Last Verified: July 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Anticoagulation
  • Additional relevant MeSH terms: Leukemia, Lymphoid
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia
    Lymphoma