Annals of hematology · 2025
Intensified pegylated-asparaginase in consolidation therapy improved outcome of allogeneic hematopoietic stem cell transplantation for adult T-cell acute lymphoblastic leukemia.
Клиническое исследование II фазыКлиническое исследование III фазыСтатьяНазвание и аннотация: Перевод в очереди
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Chen Junjie, Li Jia, Wang Zhixiang, Huang Zicong, Lin Jieping, Ou Jiawang, Xu Xiuli, Tang Bingqing, Ding Chenhao, Cai Zihong, Lin Ren, Li Xuan, Liu Qifa, Zhou Hongsheng
Аннотация
Research on the optimal consolidation therapy for adult T-cell acute lymphoblastic leukemia (T-ALL) remains limited, and how to integrate pediatric-inspired chemotherapy with allogeneic hematopoietic stem cell transplantation (SCT) is less addressed. Based on retrospective analysis indicating that 4 doses of pegylated-asparaginase (PEG-Asp) prior to SCT were optimal for survival, we designed a PEG-Asp-intensified pediatric-inspired regimen, PDT-ALL-2016, for adult T-ALL (NCT03564704). In this protocol, SCT administered following 4 or 5 doses of PEG-Asp. The impact of PEG-Asp on transplantation outcomes was evaluated in two cohorts: the prospective PDT-ALL-2016 cohort (2016.1-2021.12, N = 63) and the retrospective adult regimen cohort (2008.1-2015.12, N = 61). With intensified PEG-Asp consolidation, the prospective cohort exhibited superior survival compared to the retrospective cohort. Furthermore, within the prospective cohort, patients who received non-truncated PEG-Asp demonstrated better survival than those who received a truncated dose. Then, the entire cohort was stratified into high-dose (4-5 doses, N = 45), medium-dose (2-3 doses; N = 33) and low-dose (0-1 doses; N = 46) groups, based on the number of PEG-Asp doses administrated pre-SCT. The high-dose group showed superior survival compared to the other two groups in both the entire cohort and in subgroup analysis. Our findings indicate that high-dose PEG-Asp is associated with improved outcome in adult T-ALL undergoing SCT.