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A prospective study of an alemtuzumab containing reduced-intensity allogeneic stem cell transplant program in patients with poor-risk and advanced lymphoid malignancies

机译:风险低下和晚期淋巴恶性肿瘤患者中包含降低强度同种异体干细胞移植计划的alemtuzumab的前瞻性研究

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摘要

Reduced-intensity conditioning (RIC) regimens for allogeneic stem cell transplant (allo-SCT) have used alemtuzumab to abrogate the risk of graft-versus-host disease (GVHD). Thirty-eight patients with advanced lymphoma underwent a prospective phase II study of melphalan, fludarabine and alemtuzumab containing RIC allo-SCT from 20 matched related and 18 unrelated donors with cyclosporine-A as GVHD prophylaxis. The cumulative incidence of grade II-IV acute GVHD at 3 months was 10.5% and three evaluable patients experienced chronic GVHD. Progression-free (PFS) and overall (OS) survival at 5 years was 25% (95% confidence interval [CI]: 13-40%) and 44% (95% CI: 28-59%), respectively. Previous high-dose therapy and autologous stem cell transplant (HDT-ASCT) and elevated lactate dehydrogenase (LDH) at the time of allo-SCT resulted in inferior OS. Within this cohort of patients with high-risk lymphoma, alemtuzumab containing RIC resulted in a low risk of GVHD and a high incidence of progression of disease, especially in those with poor-risk features defined by elevated LDH pre-allo-SCT and previous HDT-ASCT.
机译:异基因干细胞移植(allo-SCT)的降低强度调节(RIC)方案已使用阿仑单抗消除了移植物抗宿主病(GVHD)的风险。对38名晚期淋巴瘤患者进行了一项前瞻性II期研究,研究了来自20个相匹配的相关供者和18个不相关的供体,其中环孢菌素A作为预防GVHD的美法仑,氟达拉滨和阿仑单抗含RIC allo-SCT。 3个月时II-IV级急性GVHD的累积发生率为10.5%,三名可评估的患者经历了慢性GVHD。 5年无进展(PFS)和总体(OS)生存率分别为25%(95%置信区间[CI]:13-40%)和44%(95%CI:28-59%)。先前的大剂量疗法和自体干细胞移植(HDT-ASCT)以及异源SCT时乳酸脱氢酶(LDH)升高导致OS降低。在这一高危淋巴瘤患者队列中,含阿仑单抗的RIC导致GVHD的低风险和疾病进展的高发生率,尤其是那些因LDH前allo-SCT升高和以前的HDT升高而具有低风险特征的患者-ASCT。

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