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
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
2 other identifiers
interventional
512
12 countries
96
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 lymphoma
Started Oct 2015
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2015
CompletedFirst Posted
Study publicly available on registry
February 24, 2015
CompletedStudy Start
First participant enrolled
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2021
CompletedResults Posted
Study results publicly available
March 8, 2022
CompletedMarch 8, 2022
February 1, 2022
5.7 years
January 21, 2015
January 7, 2022
February 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Number of Participants With Non-Fatal DVT, PE, and CVST, and VTE-Related-Death
The number of participants with non-fatal deep vein thromboses (DVT) (including asymptomatic and symptomatic), pulmonary embolism (PE), cerebral venous sinus thrombosis (CVST); and venous thromboembolism (VTE) related-death objectively confirmed by a blinded, independent adjudication committee. Symptomatic events are included during the intended treatment period. Asymptomatic events are included from scans up to Day 40.
From first dose up to approximately 40 days after first dose
The Number of Participants With Adjudicated Major Bleeding
The number of participants with major bleeding adjudicated by a blinded, independent adjudication committee. Adjudicated major bleeding is defined as bleeding that satisfies one or more of the following criteria: 1. fatal bleeding 2. clinically overt bleeding associated with a decrease in hemoglobin of at least 20g/L (ie, 2g/dL) in a 24-hour period 3. bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS; and/or 4. bleeding that requires surgical intervention in an operating suite, including interventional radiology.
From first dose up to approximately 34 days after first dose
Secondary Outcomes (19)
The Number of Participants With Non-fatal Asymptomatic Deep Vein Thromboses (DVT)
From first dose up to approximately 40 days after first dose
The Number of Participants With Non-fatal Symptomatic Deep Vein Thromboses (DVT)
From first dose up to approximately 34 days after first dose
The Number of Participants With Non-fatal Pulmonary Embolism (PE)
From first dose up to approximately 34 days after first dose
The Number of Participants With Cerebral Venous Sinus Thrombosis (CVST)
From first dose up to approximately 34 days after first dose
The Number of Participants With Venous Thromboembolism (VTE)-Related-death
From first dose up to approximately 34 days after first dose
- +14 more secondary outcomes
Study Arms (2)
Apixaban
EXPERIMENTALChildren 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
No systemic anticoagulant prophylaxis
PLACEBO COMPARATORNo systemic anticoagulant prophylaxis
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Pfizercollaborator
Study Sites (96)
Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr.
Phoenix, Arizona, 85016, United States
City of Hope
Duarte, California, 91010, United States
Loma Linda University Cancer Center
Loma Linda, California, 92350, United States
Childrens Hospital Of La
Los Angeles, California, 90027, United States
Children'S Hospital Of Orange County
Orange, California, 92868, United States
Lucile Packard Children's Hospital (LPCH)
Palo Alto, California, 94304, United States
Rady Children'S Hospital - San Diego
San Diego, California, 92123-4282, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
Nemours / A. I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Golisano Childrens Hospital of Southwest Florida
Fort Myers, Florida, 33908, United States
Shands Hospital At University Of Florida
Gainesville, Florida, 32610-0298, United States
Nemours Children'S Clinic
Jacksonville, Florida, 32207, United States
Nemours Children'S Clinic - Orlando
Orlando, Florida, 32827, United States
Nemours Children'S Clinic-Pensacola
Pensacola, Florida, 32504, United States
All Childrens Hospital Specialty Physicians
St. Petersburg, Florida, 33701, United States
St. Marys Medical Center
West Palm Beach, Florida, 33407, United States
Childrens Healthcare Of Atlanta - E
Atlanta, Georgia, 30342, United States
Navicent Health Physician Group
Macon, Georgia, 31201, United States
St. Luke'S Mountain State Tumor Institute
Boise, Idaho, 83712, United States
Children'S Center For Cancer And Blood Diseases
Indianapolis, Indiana, 46260, United States
Blank Childrens Hospital
Des Moines, Iowa, 50309, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536-0293, United States
University Of Louisville
Louisville, Kentucky, 40202, United States
Childrens Hospital New Orleans
New Orleans, Louisiana, 70118, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Sinai Hospital Of Baltimore
Baltimore, Maryland, 21215, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
University Of Michigan Cancer Center
Ann Arbor, Michigan, 48109, United States
Childrens Hospitals And Clinics Of Minnesota
Minneapolis, Minnesota, 55404, United States
University Of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
University Of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Valerie Fund Children's Center at St. Joseph's Children's Hospital
Paterson, New Jersey, 07503, United States
Albany Medical Center
Albany, New York, 12208, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
University Of Rochester General Clinical Research Center
Rochester, New York, 14642, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
New York Medical College
Valhalla, New York, 10595, United States
Unv. Of Nc At Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Akron Children'S Hospital
Akron, Ohio, 44308, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
University Hospitals
Cleveland, Ohio, 44106, United States
Nationwide Children'S Hospital
Columbus, Ohio, 43205, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital Of Pittsburgh Of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203, United States
Monroe Carell Jr Children'S Hosp. At Vanderbilt Tower
Nashville, Tennessee, 37232, United States
Dell Children'S Medical Center Of Central Texas
Austin, Texas, 78723, United States
Driscoll Children'S Hospital
Corpus Christi, Texas, 78411, United States
Texas Children's Cancer and Hematology Centers
Houston, Texas, 77030, United States
Children's Hospital of San Antonio
San Antonio, Texas, 78207, United States
University Hospital
San Antonio, Texas, 78284, United States
Scott & White - McLane Children's Specialty Clinic
Temple, Texas, 76502, United States
Providence Sacred Heart Medical Center
Spokane, Washington, 99204, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Local Institution
New Lambton Heights, New South Wales, 2305, Australia
Queensland Children's Hospital
Sth Brisbane, Queensland, 4101, Australia
Monash Medical Centre Clayton
Clayton, Victoria, 3168, Australia
Local Institution
Parkville, Victoria, 3052, Australia
Local Institution
Brussels, 1020, Belgium
Local Institution
Brussels, 1200, Belgium
Local Institution
Edegem, 2650, Belgium
Local Institution
Ghent, 9000, Belgium
Local Institution
Leuven, 3000, Belgium
Alberta Children'S Hospital
Calgary, Alberta, T3B 6A8, Canada
Local Institution
Edmonton, Alberta, T6G 2B7, Canada
Local Institution
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Children'S Hospital London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Children'S Hospital Of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Klinika detske onkologie
Brno, 613 00, Czechia
Local Institution
Budapest, 1094, Hungary
Local Institution
Debrecen, 4032, Hungary
Local Institution
Pécs, 7623, Hungary
Local Institution
Guadalajara, Jalisco, 44340, Mexico
Local Institution
Df, Mexico City, 04530, Mexico
Local Institution
Monterrey, Nuevo León, 64460, Mexico
Local Institution
Christchurch, 8011, New Zealand
Klinika Transplantacji Szpiku Onkologii i Hematologii Dzieciecej
Wroclaw, 50-556, Poland
Oddzial Hematologii i Onkologii Dzieciecej
Zabrze, 41-800, Poland
Local Institution
Caguas, 00725, Puerto Rico
Local Institution
Kirov, 610027, Russia
Local Institution
Moscow, 115478, Russia
Local Institution
Moscow, 117198, Russia
Local Institution
Saint Petersburg, 197341, Russia
Local Institution
Saint Petersburg, 197758, Russia
Local Institution
Seoul, 03080, South Korea
Local Institution
Seoul, 03722, South Korea
Related Publications (2)
Rodriguez V, O'Brien SH, Orgel E, Schultz CL, Esbenshade AJ, Memaj A, Dyme JL, Favatella NA, Mitchell LG. Safety and efficacy of apixaban thrombosis prevention in pediatric patients with obesity and acute lymphoblastic leukemia. Blood Adv. 2025 Sep 23;9(18):4738-4747. doi: 10.1182/bloodadvances.2025016160.
PMID: 40505060DERIVEDO'Brien SH, Rodriguez V, Lew G, Newburger JW, Schultz CL, Orgel E, Derr K, Ranalli MA, Esbenshade AJ, Hochberg J, Kang HJ, Dinikina Y, Mills D, Donovan M, Dyme JL, Favatella NA, Mitchell LG; PREVAPIX-ALL investigators. Apixaban versus no anticoagulation for the prevention of venous thromboembolism in children with newly diagnosed acute lymphoblastic leukaemia or lymphoma (PREVAPIX-ALL): a phase 3, open-label, randomised, controlled trial. Lancet Haematol. 2024 Jan;11(1):e27-e37. doi: 10.1016/S2352-3026(23)00314-9. Epub 2023 Nov 16.
PMID: 37980924DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2015
First Posted
February 24, 2015
Study Start
October 22, 2015
Primary Completion
July 7, 2021
Study Completion
July 7, 2021
Last Updated
March 8, 2022
Results First Posted
March 8, 2022
Record last verified: 2022-02