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Protocol Summary


Protocol No.
PSHCI-15-010
Prinicipal Investigator
McGregor, Lisa
Phase
Phase III
Age Group
Children
Scope
National
Secondary Protocol No.
ACCL1333/CV185155
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 Asparaginase
Objective
Primary Objectives:
-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.
-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 in pediatric subjects (1 to < 18 years) with newly diagnosed ALL or lymphoma (T or B cell), a functioning CVAD and receiving PEG L-asparaginase during chemotherapy induction.
Secondary Objectives:
-To assess the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on single adjudicated endpoints of non-fatal DVT (including symptomatic and asymptomatic), PE, and CVST; and 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 CVAD and receiving PEG L-asparaginase during chemotherapy induction.
-To assess the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on the composite endpoint of adjudicated major and clinically relevant non-major bleeding (CRNMB) events during 25 - 28 days of open-label treatment in pediatric subjects (1 to < 18 years) with newly diagnosed acute ALL or lymphoma (T or B cell), a functioning CVAD and receiving PEG L-asparaginase during chemotherapy induction.

Applicable Disease Sites
Lymphoid Leukemia

Non-Hodgkin's Lymphoma
Status
Open
Participating Institutions
Hershey Medical Center
Contact
Name
Suzanne Treadway
Phone No.
+1 717-531-3097
E-mail
streadway@hmc.psu.edu