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

Last updated date
Study Location
Local Institution
Saint Petersburg, Florida, 33701, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Lymphoma, Acute Lymphoblastic Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-17 year
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Lymphoma, Acute Lymphoblastic LeukemiaA 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
  1. Saint Petersburg, Florida
  2. Lexington, Kentucky
  3. Budapest,
  4. Budapest,
  5. Debrecen,
  6. Pecs,
  7. Phoenix, Arizona
  8. Duarte, California
  9. Loma Linda, California
  10. Los Angeles, California
  11. Orange, California
  12. San Diego, California
  13. Hartford, Connecticut
  14. New Haven, Connecticut
  15. Wilmington, Delaware
  16. Washington, District of Columbia
  17. Gainesville, Florida
  18. Jacksonville, Florida
  19. Orlando, Florida
  20. Pensacola, Florida
  21. Atlanta, Georgia
  22. Boise, Idaho
  23. Indianapolis, Indiana
  24. Des Moines, Iowa
  25. Iowa City, Iowa
  26. Louisville, Kentucky
  27. New Orleans, Louisiana
  28. New Orleans, Louisiana
  29. Brewer, Maine
  30. Baltimore, Maryland
  31. Baltimore, Maryland
  32. Ann Arbor, Michigan
  33. Minneapolis, Minnesota
  34. Rochester, Minnesota
  35. Jackson, Mississippi
  36. Hackensack, New Jersey
  37. New Brunswick, New Jersey
  38. Paterson, New Jersey
  39. Albany, New York
  40. Bronx, New York
  41. Buffalo, New York
  42. Rochester, New York
  43. Syracuse, New York
  44. Valhalla, New York
  45. Chapel Hill, North Carolina
  46. Winston-Salem, North Carolina
  47. Akron, Ohio
  48. Cincinnati, Ohio
  49. Cleveland, Ohio
  50. Cleveland, Ohio
  51. Columbus, Ohio
  52. Bethlehem, Pennsylvania
  53. Danville, Pennsylvania
  54. Hershey, Pennsylvania
  55. Philadelphia, Pennsylvania
  56. Nashville, Tennessee
  57. Nashville, Tennessee
  58. Austin, Texas
  59. Corpus Christi, Texas
  60. Houston, Texas
  61. San Antonio, Texas
  62. San Antonio, Texas
  63. Spokane, Washington
  64. Tacoma, Washington
  65. Milwaukee, Wisconsin
  66. Bruxelles,
  67. Bruxelles,
  68. Edegem,
  69. Gent,
  70. Leuven,
  71. Cascavel, Parana
  72. Curitiba, Parana
  73. Porto Alegre, RIO Grande DO SUL
  74. Ribeirao Preto, SAO Paulo
  75. S?o Paulo, SAO Paulo
  76. Sao Paulo,
  77. Sao Paulo,
  78. Edmonton, Alberta
  79. St. John's, Newfoundland and Labrador
  80. London, Ontario
  81. Ottawa, Ontario
  82. Calgary,
  83. Brno,
  84. Seoul,
  85. Seoul,
  86. Df, Distrito Federal
  87. Mexico City, Distrito Federal
  88. Guadalajara, Jalisco
  89. Monterrey, Nuevo LEON
  90. Christchurch,
  91. Lublin,
  92. Wroclaw,
  93. Zabrze,
  94. Caguas,
  95. Kirov,
  96. Moscow,
  97. Moscow,
  98. St.petersburg,
ALL GENDERS
1 Year+
years
MULTIPLE SITES
Advanced Information
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
  • Lymphoma
  • Acute Lymphoblastic Leukemia
Intervention  ICMJE
  • Drug: Apixaban
  • Other: No systemic anticoagulant prophylaxis
Study Arms  ICMJE
  • 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

    Intervention: Drug: Apixaban
  • Placebo Comparator: No systemic anticoagulant prophylaxis
    No systemic anticoagulant prophylaxis
    Intervention: Other: No systemic anticoagulant prophylaxis
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
 (submitted: February 25, 2016)
500
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2015)
700
Estimated Study Completion Date  ICMJE April 15, 2021
Estimated Primary Completion Date April 15, 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:

  • 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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:[email protected]
Contact: First line of the email MUST contain NCT# and Site #.
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP