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

Grants and Contracts Details

Description

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 Investigational Product(s), Dose and Mode of Administration, Duration of Treatment with Investigational Product(s): Subjects 1 to < 18 years of age will be administered apixaban twice daily by mouth or via a NGT or GT according to weight range as per below Table for approximately 28 days Research Hypothesis: Oral or enteric administration of prophylactic apixaban during induction chemotherapy will reduce the risk of venous thromboembolism (symptomatic + asymptomatic), compared to no systemic anticoagulant prophylaxis, during induction chemotherapy in children with newly diagnosed acute lymphoblastic leukemia (ALL) or lymphoma (T or B cell) with central venous line treated with asparaginase. ..
StatusFinished
Effective start/end date11/20/1911/29/21

Funding

  • Public Health Institute: $2.00

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