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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

Primary Purpose

Lymphoma, Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apixaban
No systemic anticoagulant prophylaxis
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lymphoma focused on measuring Anticoagulation

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr.
  • City of Hope
  • Loma Linda University Cancer Center
  • Childrens Hospital Of La
  • Children'S Hospital Of Orange County
  • Lucile Packard Children's Hospital (LPCH)
  • Rady Children'S Hospital - San Diego
  • Connecticut Children's Medical Center
  • Yale University School Of Medicine
  • Nemours / A. I. duPont Hospital for Children
  • Golisano Childrens Hospital of Southwest Florida
  • Shands Hospital At University Of Florida
  • Nemours Children'S Clinic
  • Nemours Children'S Clinic - Orlando
  • Nemours Children'S Clinic-Pensacola
  • All Childrens Hospital Specialty Physicians
  • St. Marys Medical Center
  • Childrens Healthcare Of Atlanta - E
  • Navicent Health Physician Group
  • St. Luke'S Mountain State Tumor Institute
  • Children'S Center For Cancer And Blood Diseases
  • Blank Childrens Hospital
  • University of Iowa Hospitals and Clinics
  • University of Kentucky
  • University Of Louisville
  • Childrens Hospital New Orleans
  • Ochsner Medical Center
  • Sinai Hospital Of Baltimore
  • Johns Hopkins University
  • University Of Michigan Cancer Center
  • Childrens Hospitals And Clinics Of Minnesota
  • University Of Minnesota
  • Mayo Clinic Rochester
  • University Of Mississippi Medical Center
  • Hackensack University Medical Center
  • Rutgers Cancer Institute of New Jersey
  • Valerie Fund Children's Center at St. Joseph's Children's Hospital
  • Albany Medical Center
  • Roswell Park Cancer Institute
  • University Of Rochester General Clinical Research Center
  • SUNY Upstate Medical University
  • New York Medical College
  • Unv. Of Nc At Chapel Hill
  • Wake Forest Baptist Health
  • Akron Children'S Hospital
  • Cincinnati Children'S Hospital Medical Center
  • University Hospitals
  • Nationwide Children'S Hospital
  • Lehigh Valley Hospital - Muhlenberg
  • Geisinger Medical Center
  • Penn State Hershey Medical Center
  • Childrens Hospital Of Philadelphia
  • Children's Hospital Of Pittsburgh Of UPMC
  • Children's Hospital at TriStar Centennial
  • Monroe Carell Jr Children'S Hosp. At Vanderbilt Tower
  • Dell Children'S Medical Center Of Central Texas
  • Driscoll Children'S Hospital
  • Texas Children's Cancer and Hematology Centers
  • Children's Hospital of San Antonio
  • University Hospital
  • Scott & White - McLane Children's Specialty Clinic
  • Providence Sacred Heart Medical Center
  • MultiCare Institute for Research & Innovation
  • Medical College of Wisconsin
  • Local Institution
  • Queensland Children's Hospital
  • Monash Medical Centre Clayton
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Alberta Children'S Hospital
  • Local Institution
  • Local Institution
  • Children'S Hospital London Health Sciences Centre
  • Children'S Hospital Of Eastern Ontario
  • Klinika detske onkologie
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Klinika Transplantacji Szpiku Onkologii i Hematologii Dzieciecej
  • Oddzial Hematologii i Onkologii Dzieciecej
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Apixaban

No systemic anticoagulant prophylaxis

Arm Description

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

No systemic anticoagulant prophylaxis

Outcomes

Primary Outcome Measures

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.
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: fatal bleeding clinically overt bleeding associated with a decrease in hemoglobin of at least 20g/L (ie, 2g/dL) in a 24-hour period bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS; and/or bleeding that requires surgical intervention in an operating suite, including interventional radiology.

Secondary Outcome Measures

The Number of Participants With Non-fatal Asymptomatic Deep Vein Thromboses (DVT)
The number of participants with non-fatal asymptomatic deep vein thromboses (DVT) adjudicated by a blinded, independent adjudication committee
The Number of Participants With Non-fatal Symptomatic Deep Vein Thromboses (DVT)
The number of participants with non-fatal symptomatic deep vein thromboses (DVT) adjudicated by a blinded, independent adjudication committee
The Number of Participants With Non-fatal Pulmonary Embolism (PE)
The number of participants with non-fatal pulmonary embolism (PE) adjudicated by a blinded, independent adjudication committee
The Number of Participants With Cerebral Venous Sinus Thrombosis (CVST)
The number of participants with cerebral venous sinus thrombosis (CVST) adjudicated by a blinded, independent adjudication committee
The Number of Participants With Venous Thromboembolism (VTE)-Related-death
The number of participants with venous thromboembolism (VTE)-related-death adjudicated by a blinded, independent adjudication committee
The Number of Participants With Major and Clinically Relevant Non-Major Bleeding (CRNMB)
The number of participants with major and clinically relevant non-major bleeding (CRNMB) adjudicated by a blinded, independent adjudication committee CRNM bleeding is defined as bleeding that satisfies one or both of the following: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition and bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room
The Number of Participant Deaths
The number of participant deaths adjudicated by a blinded, independent adjudication committee
The Number of Participants With an Arterial Thromboembolic Event
The number of participants with an arterial thromboembolic event including paradoxical embolism and stroke adjudicated by a blinded, independent adjudication committee
The Number of Participants With a CVAD-Related Infection
The number of participants with a central venous access device (CVAD)-related infection adjudicated by a blinded, independent adjudication committee
The Number of Participants Needing Catheter Replacements During the Study
The number of participants needing catheter replacements during the study
The Number of Participants With CVAD Patency Restoration Events After Thrombolytic Therapy Use
The number of participants with central venous access device (CVAD) patency restoration events after thrombolytic therapy use
The Number Participants Experiencing Superficial Vein Thrombosis Events
The number participants experiencing superficial vein thrombosis events. Clots that occur in a superficial vein ie, cephalic vein, basilic vein (upper extremity) or saphenous vein (lower extremity) confirmed by radiographic imaging.
The Number of Participants With Clinically Relevant Non-Major Bleeding Events (CRNMB)
The number of participants with clinically relevant non-major bleeding events (CRNMB) adjudicated by a blinded, independent adjudication committee. CRNM bleeding is defined as bleeding that satisfies one or both of the following: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition and bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room
The Number of Participants With Minor Bleeding Events
The number of participants with minor bleeding events adjudicated by a blinded, independent adjudication committee. Minor bleeding defined as any overt or macroscopic evidence of bleeding that does not fulfill the criteria for either major bleeding or CRNMB
The Number of Platelet Transfusions Needed During the Study
The number of platelet transfusions needed during the study. The events are not adjudicated. A subject could have more than one platelet transfusion.
Maximum Observed Concentration (Cmax)
The maximum observed concentration (Cmax) was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy.
Trough Observed Concentration (Cmin)
The trough observed concentration (Cmin) was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy.
Area Under the Concentration-Time Curve [AUC(TAU)]
The area under the concentration-time curve [AUC(TAU)] was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy.
Anti-FXa Activity
Anti-FXa Activity was measured to characterize the relationship between apixaban plasma concentration and anti-FXa activity in pediatric subjects receiving induction chemotherapy

Full Information

First Posted
January 21, 2015
Last Updated
February 10, 2022
Sponsor
Bristol-Myers Squibb
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02369653
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 Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 22, 2015 (Actual)
Primary Completion Date
July 7, 2021 (Actual)
Study Completion Date
July 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Acute Lymphoblastic Leukemia
Keywords
Anticoagulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
512 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apixaban
Arm Type
Experimental
Arm Description
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
Arm Title
No systemic anticoagulant prophylaxis
Arm Type
Placebo Comparator
Arm Description
No systemic anticoagulant prophylaxis
Intervention Type
Drug
Intervention Name(s)
Apixaban
Intervention Type
Other
Intervention Name(s)
No systemic anticoagulant prophylaxis
Primary Outcome Measure Information:
Title
The Number of Participants With Non-Fatal DVT, PE, and CVST, and VTE-Related-Death
Description
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.
Time Frame
From first dose up to approximately 40 days after first dose
Title
The Number of Participants With Adjudicated Major Bleeding
Description
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: fatal bleeding clinically overt bleeding associated with a decrease in hemoglobin of at least 20g/L (ie, 2g/dL) in a 24-hour period bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS; and/or bleeding that requires surgical intervention in an operating suite, including interventional radiology.
Time Frame
From first dose up to approximately 34 days after first dose
Secondary Outcome Measure Information:
Title
The Number of Participants With Non-fatal Asymptomatic Deep Vein Thromboses (DVT)
Description
The number of participants with non-fatal asymptomatic deep vein thromboses (DVT) adjudicated by a blinded, independent adjudication committee
Time Frame
From first dose up to approximately 40 days after first dose
Title
The Number of Participants With Non-fatal Symptomatic Deep Vein Thromboses (DVT)
Description
The number of participants with non-fatal symptomatic deep vein thromboses (DVT) adjudicated by a blinded, independent adjudication committee
Time Frame
From first dose up to approximately 34 days after first dose
Title
The Number of Participants With Non-fatal Pulmonary Embolism (PE)
Description
The number of participants with non-fatal pulmonary embolism (PE) adjudicated by a blinded, independent adjudication committee
Time Frame
From first dose up to approximately 34 days after first dose
Title
The Number of Participants With Cerebral Venous Sinus Thrombosis (CVST)
Description
The number of participants with cerebral venous sinus thrombosis (CVST) adjudicated by a blinded, independent adjudication committee
Time Frame
From first dose up to approximately 34 days after first dose
Title
The Number of Participants With Venous Thromboembolism (VTE)-Related-death
Description
The number of participants with venous thromboembolism (VTE)-related-death adjudicated by a blinded, independent adjudication committee
Time Frame
From first dose up to approximately 34 days after first dose
Title
The Number of Participants With Major and Clinically Relevant Non-Major Bleeding (CRNMB)
Description
The number of participants with major and clinically relevant non-major bleeding (CRNMB) adjudicated by a blinded, independent adjudication committee CRNM bleeding is defined as bleeding that satisfies one or both of the following: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition and bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room
Time Frame
From first dose up to approximately 34 days after first dose
Title
The Number of Participant Deaths
Description
The number of participant deaths adjudicated by a blinded, independent adjudication committee
Time Frame
From first dose date until the end of the treatment period + 30 days (Up to approximately 59 days)
Title
The Number of Participants With an Arterial Thromboembolic Event
Description
The number of participants with an arterial thromboembolic event including paradoxical embolism and stroke adjudicated by a blinded, independent adjudication committee
Time Frame
From first dose up to approximately 34 days after first dose
Title
The Number of Participants With a CVAD-Related Infection
Description
The number of participants with a central venous access device (CVAD)-related infection adjudicated by a blinded, independent adjudication committee
Time Frame
From first dose up to approximately 34 days after first dose
Title
The Number of Participants Needing Catheter Replacements During the Study
Description
The number of participants needing catheter replacements during the study
Time Frame
From first dose up to approximately 34 days after first dose
Title
The Number of Participants With CVAD Patency Restoration Events After Thrombolytic Therapy Use
Description
The number of participants with central venous access device (CVAD) patency restoration events after thrombolytic therapy use
Time Frame
From first dose up to approximately 34 days after first dose
Title
The Number Participants Experiencing Superficial Vein Thrombosis Events
Description
The number participants experiencing superficial vein thrombosis events. Clots that occur in a superficial vein ie, cephalic vein, basilic vein (upper extremity) or saphenous vein (lower extremity) confirmed by radiographic imaging.
Time Frame
From first dose up to approximately 34 days after first dose
Title
The Number of Participants With Clinically Relevant Non-Major Bleeding Events (CRNMB)
Description
The number of participants with clinically relevant non-major bleeding events (CRNMB) adjudicated by a blinded, independent adjudication committee. CRNM bleeding is defined as bleeding that satisfies one or both of the following: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition and bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room
Time Frame
From first dose up to approximately 34 days after first dose
Title
The Number of Participants With Minor Bleeding Events
Description
The number of participants with minor bleeding events adjudicated by a blinded, independent adjudication committee. Minor bleeding defined as any overt or macroscopic evidence of bleeding that does not fulfill the criteria for either major bleeding or CRNMB
Time Frame
From first dose up to approximately 34 days after first dose
Title
The Number of Platelet Transfusions Needed During the Study
Description
The number of platelet transfusions needed during the study. The events are not adjudicated. A subject could have more than one platelet transfusion.
Time Frame
From first dose up to approximately 34 days after first dose
Title
Maximum Observed Concentration (Cmax)
Description
The maximum observed concentration (Cmax) was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy.
Time Frame
pre-dose, 1-4 hours post dose
Title
Trough Observed Concentration (Cmin)
Description
The trough observed concentration (Cmin) was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy.
Time Frame
pre-dose, 1-4 hours post dose
Title
Area Under the Concentration-Time Curve [AUC(TAU)]
Description
The area under the concentration-time curve [AUC(TAU)] was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy.
Time Frame
pre-dose, 1-4 hours post dose
Title
Anti-FXa Activity
Description
Anti-FXa Activity was measured to characterize the relationship between apixaban plasma concentration and anti-FXa activity in pediatric subjects receiving induction chemotherapy
Time Frame
pre-dose and 2.5 hours after dosing on day 7. Day 8 and day 15.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Facility Name
Childrens Hospital Of La
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children'S Hospital Of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Lucile Packard Children's Hospital (LPCH)
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Rady Children'S Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123-4282
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Nemours / A. I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Golisano Childrens Hospital of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
Shands Hospital At University Of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0298
Country
United States
Facility Name
Nemours Children'S Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Nemours Children'S Clinic - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
Nemours Children'S Clinic-Pensacola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
All Childrens Hospital Specialty Physicians
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
St. Marys Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Childrens Healthcare Of Atlanta - E
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Navicent Health Physician Group
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
St. Luke'S Mountain State Tumor Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Children'S Center For Cancer And Blood Diseases
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Blank Childrens Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0293
Country
United States
Facility Name
University Of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Childrens Hospital New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Sinai Hospital Of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University Of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Childrens Hospitals And Clinics Of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University Of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University Of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Valerie Fund Children's Center at St. Joseph's Children's Hospital
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
University Of Rochester General Clinical Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Unv. Of Nc At Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Akron Children'S Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Cincinnati Children'S Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Nationwide Children'S Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Lehigh Valley Hospital - Muhlenberg
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Childrens Hospital Of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital Of Pittsburgh Of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Children's Hospital at TriStar Centennial
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Monroe Carell Jr Children'S Hosp. At Vanderbilt Tower
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Dell Children'S Medical Center Of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Driscoll Children'S Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Texas Children's Cancer and Hematology Centers
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Children's Hospital of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
University Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Scott & White - McLane Children's Specialty Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76502
Country
United States
Facility Name
Providence Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
MultiCare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Queensland Children's Hospital
City
Sth Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Monash Medical Centre Clayton
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Local Institution
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Local Institution
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Alberta Children'S Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Local Institution
City
St, John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Children'S Hospital London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Children'S Hospital Of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Klinika detske onkologie
City
Brno
ZIP/Postal Code
613 00
Country
Czechia
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Facility Name
Local Institution
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Local Institution
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Local Institution
City
Df
State/Province
Distrito Federal
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Klinika Transplantacji Szpiku Onkologii i Hematologii Dzieciecej
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Oddzial Hematologii i Onkologii Dzieciecej
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Local Institution
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Local Institution
City
Kirov
ZIP/Postal Code
610027
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation
Facility Name
Local Institution
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Local Institution
City
St.petersburg
ZIP/Postal Code
197341
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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