(ACCL1333/CV185-155) 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 Asparaginase
Description: 

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 symptomatic and asymptomatic), pulmonary embolism (PE), and cerebral venous sinus thrombosis (CVST); and venous thromboembolism (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 PEG L-asparaginase during chemotherapy induction.

Study Number: 

PH 271115

Phase: 
III
Principal Investigator: 
ClinicalTrials.Gov ID: 
NCT02369653

To inquire about participating in these studies, call 1-877-ASK-RPCI (1-877-275-7724) or e-mail askrpci@roswellpark.org.