Effect of graft-versus-host disease prophylaxis on 3-year disease-free survival in recipients of unrelated donor bone marrow (T-cell Depletion Trial): a multi-centre, randomised phase II-III trial
Effect of graft-versus-host disease prophylaxis on 3-year disease-free survival in recipients of unrelated donor bone marrow (T-cell Depletion Trial): a multi-centre, randomised phase II-III trial
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DOI：
10.1016/s0140-6736(05)66996-6
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发表时间：
2005-08-27
期刊：
影响因子：
168.9
通讯作者：
Kernan, NA
中科院分区：
文献类型：
--
作者：
Wagner, JE;Thompson, JS;Kernan, NA
背景 移植物抗宿主病（GVHD）会降低淋巴造血系统恶性肿瘤患者的无关供体骨髓移植的疗效。进行了一项多中心、随机试验，以确定离体 T 细胞耗竭与甲氨蝶呤和环孢素免疫抑制对 3 年无病生存率的影响。 方法 1995 年 3 月 1 日至 2000 年 10 月 31 日期间，来自 15 个参与中心的 405 名淋巴造血系统恶性肿瘤患者被随机分配接受 T 细胞耗竭骨髓移植和环孢素 A（TCD 组；n=201）或 T 充足骨髓移植后甲氨蝶呤和环孢素 A（M/C 组；n=204）。主要结局是 3 年无病生存率，并按意向治疗进行分析。结果 5 名患者在移植前死亡。 TCD 组中的 7 人接受了充满 T 的移植物。 TCD 和 M/C 接受者的 3 年无病生存率分别为 27% (95% CI 21-33) 和 34% (27-40) (p=0.16)。 TCD 与中性粒细胞恢复速度显着加快相关（15 天与 20 天，p
Background Graft-versus-host disease (GVHD) reduces the efficacy of unrelated donor bone marrow transplantation in patients with lymphohaemopoietic malignancy. A multi-centre, randomised trial was undertaken to determine the effects of ex-vivo T-cell depletion versus methotrexate and cyclosporine immunosuppression on 3-year disease-free survival.Methods Between Mar 1, 1995, and Oct 31, 2000, 405 patients with lymphohaemopoietic malignancy, from 15 participating centres, were randomly assigned to undergo transplantation with either T-cell depleted marrow and cyclosporine A (TCD arm; n=201) or methotrexate and cyclosporine A after transplantation of T-replete marrow (M/C arm; n=204). The primary outcome was 3-year disease-free survival and was analysed by intention to treat.Findings Five patients died before transplantation. Seven in the TCD arm received T-replete grafts. Disease-free survival at 3 years was 27% (95% CI 21-33) and 34% (27-40) in recipients of TCD and M/C, respectively (p=0.16). TCD was associated with significantly more rapid neutrophil recovery (15 days vs 20 days, p