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-centre 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

Summary:

To compare the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on the composite endpoint of adjudicated non-fatal deep vein thrombosis (DVT, including asymptomatic and symptomatic), pulmonary embolism (PE), and cerebral venous sinus thrombosis (CSVT); and venous thrombosis (VTE) -related-death during 25-28 days of open-label treatment in pediatric subjects (1 to < 18 years) with newly diagnosed ALL or lymphoma (T or B cell), a functioning Central Venous Access Device(CVAD) and receiving pegylated L-asparaginase during chemotherapy induction and to assess the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on adjudicated major bleeding events during 25-28 days of open-label treatment.

Trial Description

Primary Outcome:

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

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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