The Clinical Impact of End-of-Consolidation Measurable Residual Disease in High-Risk Pediatric B-Cell Acute Lymphoblastic Leukemia.
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IntroductionBlinatumomab (BLINA) has improved event-free survival (EFS) and overall survival (OS) in pediatric patients with high-risk B-cell acute lymphoblastic leukemia (ALL) and has become an effective bridging therapy to hematopoietic cell transplantation. However, the prognostic significance of end-of-consolidation (EoC) measurable residual disease (MRD) in the current BLINA-incorporated treatment era remains unclear.MethodsWe retrospectively enrolled pediatric patients diagnosed with high-risk B-cell ALL between February 2022 and December 2024 at Chang Gung Memorial Hospital. Patients were categorized into EoC MRD-negative and EoC MRD-positive groups. EoC MRD was assessed by multiparameter flow cytometry, with real-time quantitative polymerase chain reaction used as a complementary molecular method when applicable. Outcomes of interest included EFS, OS, and BLINA-related adverse events (AEs).ResultsThe cohort consisted of 15 patients. With a median follow-up of 24 months, the observed 2-year EFS and OS rates were 71.5% and 86.7%, respectively. The EoC MRD-positive group demonstrated significantly higher relapse rates (57.1% vs. 0%, P = 0.0256) and numerically higher mortality rates (28.6% vs. 0%, P = 0.2). The 2-year EFS was significantly higher in the EoC MRD-negative group (100% vs. 42.9%, P = 0.02). Although the EoC MRD-negative group demonstrated a numerically higher 2-year OS (100% vs. 71.9%, P = 0.12), the difference did not reach statistical significance. Regarding safety, no high-grade short-term or long-term BLINA-related AEs were observed in either group.ConclusionIn this preliminary retrospective study, EoC MRD negativity was associated with sustained disease control during short-term follow-up and favorable survival outcomes in pediatric patients with high-risk B-cell ALL treated with BLINA-based therapy. These findings suggest that EoC MRD assessment might provide additional prognostic information in the contemporary BLINA treatment era. Further prospective studies with larger cohorts are warranted to validate these observations.