A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With 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 Asparaginase

Summary:

The purpose of this study is to compare the effect of a blood thinning drug called Apixaban versus no administration of a blood thinning drug, in preventing blood clots in children with leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase, and have a central line (a catheter inserted for administration of medications and blood sampling)

Trial Description

Primary Outcome:

• Efficacy: A composite of adjudicated non-fatal deep vein thrombosis (DVT, including asymptomatic and symptomatic), pulmonary embolism (PE), and cerebral venous sinus thrombosis (CSVT) and venous thromboembolism (VTE)-related-death
• Safety: Adjudicated major bleeding using the International Society on Thrombosis and Haemostasis (ISTH) definition for children

• Efficacy: a) Non-fatal asymptomatic DVT
• Efficacy: b) Non-fatal symptomatic DVT
• Efficacy: c) Non-fatal PE
• Efficacy: d) CSVT
• Efficacy: e) VTE-related-death
• Safety: Composite of major and clinically relevant non major bleeding (CRNMB) using the ISTH definition for children
• Pharmacodynamics: Anti-FXa Activity measured by plasma concentration assay
• Pharmacokinetics: Measured by maximum observed concentration (Cmax)
• Pharmacokinetics: Measured by trough observed concentration (Cmin)
• Pharmacokinetics: Measured by area under the concentration-time curve in one dosing interval [AUC(TAU)]

View this trial on ClinicalTrials.gov