Prognostic significance of PCR-based measurable residual disease post-induction and during consolidation in pediatric KMT2A-rearranged acute myeloid leukemia.
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OBJECTIVE: To evaluate the prognostic value of PCR-based measurable residual disease (PCR-MRD) in pediatric KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). METHODS: Forty-six children with KMT2A-r AML were monitored by PCR-MRD and multiparametric flow cytometry-based measurable residual disease (MFC-MRD) at the end of induction courses 1 and 2 (EOI1, EOI2) and post first consolidation (EOC1). MRD ≥ 0.01% was defined as positive. Outcomes included overall survival (OS), leukemia-free survival (LFS), and cumulative incidence of relapse (CIR). RESULTS: The median PCR-MRD levels decreased from EOI1 to EOC1. Among the total 96 paired samples of PCR-MRD and MFC-MRD assessment from EOI1 to EOC1, 48.9% showed concordance within the same log unit, 13.5% of total samples exhibited significant divergence (>1 log difference). Univariate and multivariate analyses demonstrated that PCR-MRD positivity at EOI1 and EOI2 was independently associated with inferior LFS and CIR, whereas allo-HSCT in first complete remission reduced CIR. Notably, EOC1 PCR-MRD positivity was significantly associated with inferior OS (p = 0.006), LFS (p = 0.014), and CIR (p = 0.003). CONCLUSION: PCR-MRD assessment during induction and consolidation provides critical prognostic information and should be integrated into risk stratification to optimize treatment strategies in pediatric KMT2A-r AML. REGISTRY: https://www.chictr.org.cn, CHICTR1900027146, REGISTRATION DATE: 2 November, 2019; ChiCTR2400080307, Registration date: 25 January, 2024.