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Trial record 1 of 1 for:    nct02369653
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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 Pegylated (PEG) L-Asparaginase

This study is currently recruiting participants.
Verified December 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02369653
First Posted: February 24, 2015
Last Update Posted: December 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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 Pegylated L-Asparaginase and have a central line (a catheter inserted for administration of medications and blood sampling).

Condition Intervention Phase
Lymphoma Acute Lymphoblastic Leukemia Drug: Apixaban Other: No systemic anticoagulant prophylaxis Phase 3

Study Type: Interventional
Study Design: 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 Pegylated L-Asparaginase

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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

  • 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:
  • Efficacy: a) Non-fatal asymptomatic DVT [ Time Frame: Up to 1 month ]
  • Efficacy: b) Non-fatal symptomatic DVT [ Time Frame: Up to 1 month ]
  • Efficacy: c) Non-fatal PE [ Time Frame: Up to 1 month ]
  • Efficacy: d) CSVT [ Time Frame: Up to 1 month ]
  • Efficacy: e) VTE-related-death [ Time Frame: Up to 1 month ]
  • Safety: Composite of major and clinically relevant non major bleeding (CRNMB) using the ISTH definition for children [ Time Frame: Up to 1 month ]
  • Pharmacodynamics: Anti-FXa Activity measured by plasma concentration assay [ Time Frame: Up to 1 month ]
  • Pharmacokinetics: Measured by maximum observed concentration (Cmax) [ Time Frame: Up to 1 month ]
  • Pharmacokinetics: Measured by trough observed concentration (Cmin) [ Time Frame: Up to 1 month ]
  • Pharmacokinetics: Measured by area under the concentration-time curve in one dosing interval [AUC(TAU)] [ Time Frame: Up to 1 month ]

Estimated Enrollment: 500
Actual Study Start Date: April 9, 2015
Estimated Study Completion Date: May 28, 2020
Estimated Primary Completion Date: May 28, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apixaban

Children assigned to the apixaban arm <35 kg will get a dose of 0.07 mg/kg twice a day with the 0.4 mg/ml solution for 25-28 days

Children assigned to the apixaban arm ≥ 35 kg will either get a 2.5 mg tablet twice a day or 6.2 ml of the 0.4 mg/ml solution twice a day for 25-28 days

Drug: Apixaban
Placebo Comparator: No systemic anticoagulant prophylaxis
No systemic anticoagulant prophylaxis
Other: No systemic anticoagulant prophylaxis

  Eligibility

Information from the National Library of Medicine

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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 induction chemotherapy with a corticosteroid, vincristine and a single dose or multiple doses of PEG L-asparaginase, with or without daunorubicin consistent with the Children's Oncology Group (COG) ALL trials
  • 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.
  • Platelet Counts ≥ 20000/microL

Exclusion Criteria:

  • Subjects scheduled to have > 3 Lumbar Punctures over the course of the 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
  Contacts and Locations
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
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 #.

  Show 64 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02369653     History of Changes
Other Study ID Numbers: CV185-155
2014-000328-47 ( EudraCT Number )
First Submitted: January 21, 2015
First Posted: February 24, 2015
Last Update Posted: December 12, 2017
Last Verified: December 2017

Keywords provided by Bristol-Myers Squibb:
Anticoagulation

Additional relevant MeSH terms:
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