[Safety of blinatumomab combined with dasatinib in the treatment of pediatric Philadelphia chromosome-positive acute lymphoblastic leukemia].
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OBJECTIVES: To evaluate the safety of blinatumomab combined with dasatinib in children with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). METHODS: A retrospective review was conducted of clinical data for children with Ph+ ALL treated with blinatumomab plus dasatinib in the Department of Pediatrics, Peking University People's Hospital, from August 2023 to June 2025. Adverse events during therapy were recorded to assess safety. RESULTS: Ten children were included (7 boys, 3 girls), with a total of 13 instances of combination therapy. After treatment, BCR∶∶ABL1 transcript levels decreased from baseline or remained persistently negative. At a median follow-up of 13 months, all patients were alive without disease relapse. During treatment, dasatinib trough and peak plasma concentrations were not significantly affected (P>0.05). Major adverse events were as follows: hematologic toxicity (grade I-II: 77%; grade III-IV: 23%; median time to onset: 4 days; median duration: 7 days), cytokine release syndrome (all grade I; incidence: 61%; median time to onset: 3 days; duration: 2 days), neurotoxicity (grade I-II: 30%; grade III-IV: 7%; median time to onset: 3 days; duration: 1 day), and hypogammaglobulinemia (incidence: 90%; median time to onset: 13 days), with six patients requiring long-term intravenous immunoglobulin therapy. All adverse events resolved with supportive care, and no treatment-related deaths occurred. CONCLUSIONS: Blinatumomab combined with dasatinib is well tolerated in pediatric Ph+ ALL, and the adverse events are manageable.