Efficacy of Blinatumomab in Pediatric Acute Lymphoblastic Leukemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Blinatumomab, a bispecific T-cell engager antibody, has emerged as a promising immunotherapeutic agent for pediatric acute lymphoblastic leukemia (ALL), yet comprehensive evidence regarding its efficacy remains limited. This systematic review and meta-analysis aimed to evaluate the therapeutic outcomes of blinatumomab in children with ALL. A comprehensive literature search was conducted across PubMed, EMBASE, Web of Science, and Cochrane Library databases from inception to May 2025, using terms related to blinatumomab, ALL, and pediatric populations. Studies comparing blinatumomab with chemotherapy or placebo in children and adolescents with B-cell ALL were included. Three randomized controlled trials met the inclusion criteria and were analyzed using random-effects models. Quality assessment was performed using the Cochrane Risk of Bias Tool (RoB 2, Cochrane Collaboration, London, UK). The meta-analysis demonstrated significantly superior outcomes with blinatumomab compared to chemotherapy alone. Overall survival was significantly higher in the blinatumomab group, with an odds ratio of 1.90 (95% CI: 1.28-2.82). Event-free survival showed even greater improvement with an odds ratio of 2.97 (95% CI: 2.13-4.13). Additionally, the cumulative incidence of relapse was substantially lower in patients receiving blinatumomab, with an odds ratio of 0.26 (95% CI: 0.18-0.39). No evidence of heterogeneity was observed across studies for any outcome measure. These findings suggest that blinatumomab offers significant therapeutic advantages over conventional chemotherapy in pediatric patients with ALL, providing improved survival outcomes and reduced relapse rates. The results support the integration of blinatumomab into treatment protocols for children with ALL, particularly those at high risk of relapse or with refractory disease.