阿仑单抗被推荐作为 T 细胞幼淋巴细胞白血病 (T-PLL) 的一线和二线疗法。本研究回顾性评估了阿仑单抗对 2015 年 1 月至 2023 年 8 月期间在 5 个参与机构接受治疗的 9 名日本 T-PLL 患者的疗效和安全性。阿仑单抗首次给药的中位年龄为 72 岁（范围：39 至 78 岁） 。两名患者未接受过治疗，七名患者之前已接受过中位数 1 次（范围为 1 至 3 次）全身治疗。六名患者对其最近的治疗耐药。三名患者完成了 12 周的治疗。总体缓解率和完全缓解（CR）率分别为78%和11%。在获得部分缓解的 6 名患者中，有 2 名患者获得临床 CR，但未进行骨髓检查。一名患者也达到了临床 CR，但没有接受 CT 或骨髓检查来评估疗效。中位无进展生存时间为 8.1 个月（95% 置信区间，0.9 至 18.6）。三名患者在疾病进展后再次接受阿仑单抗单药治疗。没有出现与治疗相关的死亡。 3 级或 4 级非血液学不良事件包括输注反应（3 级，n = 2）、巨细胞病毒再激活（3 级，n = 2）和肺水肿（3 级，n = 1）。一名患者在最后一次服用阿仑单抗 15 个月后出现 Epstein-Barr 病毒阳性弥漫性大 B 细胞淋巴瘤。这些结果证实，阿仑单抗单一疗法在日本患者中的疗效和安全性与之前报道的相当。

Alemtuzumab is recommended as first-line and second-line therapies for T-cell prolymphocytic leukemia (T-PLL). This study retrospectively evaluated the efficacy and safety of alemtuzumab in nine Japanese patients with T-PLL at five participating institutions who were treated between January 2015 and August 2023. The median age at first administration of alemtuzumab was 72 years (range, 39 to 78). Two patients were treatment naïve, and seven had been treated with a median of one (range, 1 to 3) prior systemic therapy. Six patients were refractory to their most recent therapy. Three patients completed 12 weeks of treatment. The overall response rate and the complete response (CR) rate were 78% and 11%, respectively. Among the six patients who achieved a partial response, two achieved clinical CR but did not undergo bone marrow examination. One patient also achieved clinical CR but did not undergo CT or bone marrow examination for response evaluation. The median progression-free survival time was 8.1 months (95% confidence interval, 0.9 to 18.6). Three patients received readministration of alemtuzumab monotherapy after disease progression. There were no treatment-related deaths. The grade 3 or 4 nonhematologic adverse events included infusion reaction (grade 3, n = 2), cytomegalovirus reactivation (grade 3, n = 2), and pulmonary edema (grade 3, n = 1). One patient experienced Epstein‒Barr virus-positive diffuse large B-cell lymphoma 15 months after the last dose of alemtuzumab. These results confirm that the efficacy and safety of alemtuzumab monotherapy in Japanese patients are comparable to those previously reported.