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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

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ClinicalTrials.gov Identifier: NCT02369653
Recruitment Status : Recruiting
First Posted : February 24, 2015
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 Intervention/treatment Phase
Lymphoma Acute Lymphoblastic Leukemia Drug: Apixaban Other: No systemic anticoagulant prophylaxis Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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 9, 2015
Estimated Primary Completion Date : May 28, 2020
Estimated Study Completion Date : May 28, 2020

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Arms and Interventions
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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
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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
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Ages Eligible for Study:   1 Year to 17 Years   (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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369653


Contacts
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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 #.

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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02369653     History of Changes
Other Study ID Numbers: CV185-155
2014-000328-47 ( EudraCT Number )
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019

Keywords provided by Bristol-Myers Squibb:
Anticoagulation

Additional relevant MeSH terms:
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Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Apixaban
Anticoagulants
Asparaginase
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents