Advanced-stage cutaneous T-cell lymphomas (CTCLs) are rare, usually refractory, and fatal diseases. Case series have suggested that allogeneic haematopoietic stem cell transplantation (HSCT) might improve the prognosis of advanced-stage CTCLs. The objective of this study was to investigate the effect of allogeneic HSCT compared with non-HSCT therapy on the outcome of individuals with advanced-stage CTCLs. In this prospective, multicentre, matched controlled trial, conducted at 30 hospitals, participants with advanced CTCLs were allocated treatment: if they had an available compatible related donor they were assigned to allogeneic HSCT, or if not they were allocated to non-allogeneic HSCT therapy. Key inclusion criteria were participants aged 18–70 years, with advanced stage mycosis fungoides or Sézary syndrome, and at least one poor prognostic criteria. Participants were excluded if they were not in complete or partial remission of the disease. Propensity score 1:1 matching with replacement (ie, that each participant treated with HSCT was matched to the participant with the closest propensity score treated with non-HSCT therapy, even if they had already been matched) was used to handle confounding factors, with the balance of covariate distribution between HSCT and non-HSCT groups assessed using standardised mean differences. The primary endpoint was progression-free survival in the matched intention-to-treat population. This trial is registered with (), and is currently active but not recruiting. From June 1, 2016, to March 3, 2022, total of 99 participants were enrolled at 17 centres in France. Participants with a sibling or matched unrelated donor were assigned to allogeneic HSCT (HSCT group, n=55 [56%]) and participants without a donor were assigned to non-allogeneic HSCT treatment (non-HSCT group, n=44 [44%]). The median follow-up among survivors was 12·6 months (IQR 11·0–35·2). In the HSCT group, 51 participants (93%) were 1:1 matched to participants from the non-HSCT group. In the intention-to-treat analysis, median progression-free survival was significantly longer in the HSCT group (9·0 months [95% CI 6·6–30·5]) than in the non-HSCT group (3·0 months [2·0–6·3]), with a hazard ratio of 0·38 (95% CI 0·21–0·69; p<0·0001). In the per-protocol population, 40 participants (78%) in the HSCT group had 101 serious events and 29 participants (67%) in the non-HSCT group had 70 serious adverse events. The most common serious adverse event other than graft-versus-host disease in both groups was infections, occurring in 30 participants (59%) in the HSCT group and in 19 participants (44%) in the non-HSCT group. Allogeneic HSCT was associated with significantly longer progression-free survival in participants with advanced-stage CTCLs. These results indicate that allogeneic HSCT treatment should be made available to individuals with high-risk, advanced-stage mycosis fungoides or Sézary syndrome who achieve pre-transplant disease remission. French Ministry of Health, National Cancer Institute, Programme Hospitalier de Recherche Clinique en Cancérologie.

中文翻译：

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晚期皮肤 T 细胞淋巴瘤的同种异体移植 (CUTALLO)：倾向评分匹配的对照前瞻性研究

晚期皮肤 T 细胞淋巴瘤 (CTCL) 是一种罕见、通常难治且致命的疾病。病例系列表明，同种异体造血干细胞移植（HSCT）可能会改善晚期 CTCL 的预后。本研究的目的是探讨同种异体 HSCT 与非 HSCT 治疗相比对晚期 CTCL 患者预后的影响。在这项在 30 家医院进行的前瞻性、多中心、匹配对照试验中，患有晚期 CTCL 的参与者被分配治疗：如果他们有可用的相容相关供体，则他们被分配到同种异体 HSCT，否则，他们被分配到非同种异体 HSCT 治疗。主要纳入标准是年龄 18-70 岁、患有晚期蕈样肉芽肿或 Sézary 综合征的参与者，并且至少有一项不良预后标准。如果参与者的疾病未完全或部分缓解，则被排除在外。倾向评分 1:1 匹配与替换（即，每个接受 HSCT 治疗的参与者与接受非 HSCT 治疗的倾向评分最接近的参与者相匹配，即使他们已经匹配）用于处理混杂因素，使用标准化均值差评估 HSCT 和非 HSCT 组之间协变量分布的平衡。主要终点是匹配的意向治疗人群的无进展生存期。该试验已在 () 注册，目前正在进行中，但尚未招募。从2016年6月1日到2022年3月3日，法国17个中心共有99名参与者入组。有兄弟姐妹或匹配的无关供体的参与者被分配到同种异体 HSCT（HSCT 组，n=55 [56%]），没有供体的参与者被分配到非同种异体 HSCT 治疗（非 HSCT 组，n=44 [44%]） ]）。幸存者的中位随访时间为 12·6 个月 (IQR 11·0–35·2)。在 HSCT 组中，51 名参与者 (93%) 与非 HSCT 组的参与者进行 1:1 匹配。在意向治疗分析中，HSCT 组的中位无进展生存期（9·0 个月 [95% CI 6·6–30·5]）明显长于非 HSCT 组（3·0个月 [2·0–6·3]），风险比为 0·38（95% CI 0·21–0·69；p<0·0001）。在符合方案的人群中，HSCT 组的 40 名参与者 (78%) 发生了 101 起严重事件，非 HSCT 组的 29 名参与者 (67%) 发生了 70 起严重不良事件。两组中除移植物抗宿主病外最常见的严重不良事件是感染，发生在 HSCT 组的 30 名参与者（59%）和非 HSCT 组的 19 名参与者（44%）。同种异体 HSCT 与晚期 CTCL 参与者的无进展生存期显着延长相关。这些结果表明，同种异体 HSCT 治疗应该适用于患有高危、晚期蕈样肉芽肿或 Sézary 综合征且实现移植前疾病缓解的个体。