Clinical Trials /

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

Description:

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)

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Lymphoma
  • Mixed Phenotype Acute Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • 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 Pegylated (PEG) L-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 Pegylated L-Asparaginase

Clinical Trial IDs

  • ORG STUDY ID: CV185-155
  • SECONDARY ID: 2014-000328-47
  • NCT ID: NCT02369653

Conditions

  • Lymphoma
  • Acute Lymphoblastic Leukemia

Interventions

DrugSynonymsArms
ApixabanApixaban

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).

Trial Arms

NameTypeDescriptionInterventions
ApixabanExperimentalChildren 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
  • Apixaban
No systemic anticoagulant prophylaxisPlacebo ComparatorNo systemic anticoagulant prophylaxis

    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 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
          
    Maximum Eligible Age:17 Years
    Minimum Eligible Age:1 Year
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure: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
    Safety Issue:
    Description:Objectively confirmed by independent adjudication

    Secondary Outcome Measures

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

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Bristol-Myers Squibb

    Trial Keywords

    • Anticoagulation

    Last Updated

    April 17, 2017