Safety and Efficacy Study of Apixaban to Prevent Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With PEG 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: The primary efficacy endpoint is a composite of adjudicated non-fatal DVT (including asymptomatic and symptomatic), PE, and CSVT and VTE-related-death objectively confirmed by independent adjudication
  • Safety: The primary safety endpoint will be 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) Non-fatal CSVT
  • Efficacy: e) VTE-related-death
  • Safety: Composite of major and clinically relevant non major bleeding (CRNMB) using the ISTH definition for children

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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