Pegylated asparaginase during induction therapy in children with intermediate-risk acute lymphoblastic leukemia: results of a randomized study

This study investigated the efficacy and safety of the use of pegaspargase on day 3 of remission induction in children with intermediate-risk acute lymphoblastic leukemia (ALL). The study was approved by the Independent Ethics Committee and the Scientific Council of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of Ministry of Healthcare of the Russian Federation. The study included 1470 children with intermediate-risk ALL. The patients were randomized into two groups to receive pegaspargase (1000 IU/m²) on day 3 of induction or not to receive pegaspargase. There was no significant difference in event-free survival between the pegaspargase and non-pegaspargase groups. In the pegaspargase group, the cumulative incidence of relapse was significantly lower (8.3% vs. 13.1%; p = 0.02). A particularly notable reduction in relapse incidence was seen in the patients with B-lineage ALL, especially in those over 10 years of age. There were no significant differences in early mortality, overall survival, and incidence of hypersensitivity reactions between the two groups. The administration of pegaspargase on day 3 of induction in the patients with intermediate-risk ALL significantly reduced relapse rates without increasing toxicity. This finding led to the inclusion of pegaspargase in the updated ALL MB 2015 protocol, which is now routinely used in the treatment of children and adolescents with ALL in Russia.