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
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.
View this trial on ClinicalTrials.gov
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