Sarah H O'Brien, Vilmarie Rodriguez, Glen Lew, Jane W Newburger, Corinna L Schultz, Etan Orgel, Kimberly Derr, Mark A Ranalli, Adam J Esbenshade, Jessica Hochberg, Hyoung Jin Kang, Yulia Dinikina, Donna Mills, Mark Donovan, Joshua L Dyme, Nicholas A Favatella, Lesley G Mitchell
BACKGROUND: Paediatric patients with acute lymphoblastic leukaemia or lymphoma are at increased risk of venous thromboembolism resulting in increased mortality and morbidity. We hypothesised that apixaban, a direct oral anticoagulant, would safely reduce venous thromboembolism in this patient population. METHODS: PREVAPIX-ALL was a phase 3, open-label, randomised, controlled trial conducted in 74 paediatric hospitals in 9 countries. Participants aged 1 year or older to younger than 18 years with newly diagnosed acute lymphoblastic leukaemia (pre-B cell or T cell) or lymphoblastic lymphoma (B cell or T cell immunophenotype) and a central venous line in place throughout induction were randomly assigned 1:1 to standard of care (SOC, ie, no systemic anticoagulation) or weight-adjusted twice-daily apixaban during induction...
January 2024: Lancet Haematology