首页|Haploidentical hematopoietic cell transplantation with or without an unrelated cord blood unit for adult acute myeloid leukemia:a multicenter,randomized,open-label,phase 3 trial

Haploidentical hematopoietic cell transplantation with or without an unrelated cord blood unit for adult acute myeloid leukemia:a multicenter,randomized,open-label,phase 3 trial

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Coinfusion of unrelated cord blood(UCB)units in haploidentical hematopoietic cell transplantation(haplo-HCT)(haplo-cord HCT)for hematopoietic malignancies showed promising results in previous reports,but the efficiency of haplo-cord HCT in acute myeloid leukemia(AML)still lacks sufficient evidence.This multicenter,randomized,phase 3 trial(ClinicalTrials.gov NCT03719534)aimed to assess the efficacy and safety of haplo-cord HCT in AML patients.A total of 268 eligible patients aged 18-60 years,diagnosed with measurable residual disease in AML(excluding acute promyelocytic leukemia),with available haploidentical donors and suitable for allotransplantation,were randomly allocated(1:1)to receive haplo-cord HCT(n=134)or haplo-HCT(n=134).The 3-year overall survival(OS)was the primary endpoint in this study.Overall median follow-up was 36.50 months(IQR 24.75-46.50).The 3-year OS of Haplo-cord HCT group was better than haplo-HCT group(80.5％,95％confidence interval[CI]:73.7-87.9 vs.67.8％95％CI 60.0-76.5,p=0.013).Favorable progression-free survival(70.3％,95％CI 62.6-78.8 vs.57.6％,95％CI 49.6-67.0,p=0.012)and cumulative incidence of relapse(12.1％,95％CI 12.0-12.2 vs.30.3％,95％CI 30.1-30.4,p=0.024)were observed in haplo-cord HCT group.Grade 3-4 adverse events(AEs)within two years posttransplantation in the two groups were similar.Haplo-cord HCT patients exhibited a faster cumulative incidence of neutrophil recovery(p=0.026)and increased T-cell reconstitution in the early period posttransplantation.Haplo-cord HCT can improve OS in AML patients without excessive AEs,which may exert additional benefits for recipients of haplo-HCT.

Biqi Zhou、Jia Chen、Tianhui Liu、Yishan Ye、Yanming Zhang、Yiyang Ding、Hong Liu、MingQing Zhu、Xiao Ma、Xiaoli Li、Longfei Zhao、Zhihong Lin、He Huang、Yang Xu、Depei Wu

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National Clinical Research Center for Hematologic Diseases,Jiangsu Institute of Hematology,The First Affiliated Hospital of Soochow University,Suzhou,China

Institute of Blood and Marrow Transplantation,Collaborative Innovation Center of Hematology,Soochow University,Suzhou,China

Bone Marrow Transplantation Center,The First Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou,Zhejiang,China

Department of Hematology,The Affiliated Huai'an Hospital of Xuzhou Medical University and The Second People's Hospital of Huai'an,Huai'an,China

Soochow Hopes Hematology Hospital,Suzhou,China

Department of Hematology,Hygeia Suzhou Yongding Hospital,Suzhou,China

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National Key Research and Development ProgramNational Natural Science Foundation of ChinaNational Natural Science Foundation of ChinaNational Natural Science Foundation of ChinaNational Natural Science Foundation of ChinaNational Natural Science Foundation of ChinaNational Natural Science Foundation of ChinaPriority Academic Program Development of Jiangsu Higher Education Institutions(PAPD)Jiangsu Provincial Medical Innovation CenterExcellent Youth Science Fund of Jiangsu ProvinceSuzhou Science ProjectSuzhou Science ProjectSuzhou Science and Technology ProjectTranslational Research Grant of NCRCH

2022YFC2502700820201080038237021382370215823002428207018782000180CXZX202201BK20211553SKY2021104SKY2021039SLT2019112021ZKMB01

2024

10.1038/s41392-024-01820-5

信号转导与靶向治疗(英文)

信号转导与靶向治疗(英文)

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年,卷(期)：2024.9(6)