自体造血干细胞移植（ASCT）后，需要改进复发/难治侵袭性淋巴瘤患者的维护治疗。几项关于来那度胺治疗复发/难治侵袭性淋巴瘤的研究表明其具有一定的活性。在目前的Ⅰ/Ⅱ相单臂开放性研究中，59例高危复发非何杰金淋巴瘤患者在接受预移植BEAM化疗及ASCT治疗后，从移植后100天开始每天使用12个月的利妥昔单抗维持治疗，剂量为每日1次，第1天至第21天(28天为1个周期)。最常见的组织学类型是曼托细胞淋巴瘤（56％）和弥漫性大B细胞性淋巴瘤（24％）。在研究的剂量确定阶段，最大可耐受剂量为15毫克，但细胞减少症导致后续采用了10毫克剂量。16例患者（27％）完成了利妥昔单抗维持治疗的12个周期。停止治疗的最常见原因是不良事件（31％），主要是血液学方面，56％的患者出现3-4级事件。所有患者、完成12个月维持治疗的患者和未完成12个月维持治疗的患者的2年无进展生存率（95％置信区间）分别为70％（56％-80％）、45％（19％-68％）和81％（66％-90％）；2年总生存率(95% CIs)分别为91% (80%-96%)、93% (61%-99%)和90% (76%-96%)。这些结果不支持在这种情况下使用利妥昔单抗维持治疗。 © 2023 The Authors。英国血液学杂志由英国血液学协会和约翰威利和亚姆斯有限公司出版。

Improved maintenance treatments are needed for patients with relapsed/refractory aggressive lymphomas after autologous haematopoietic stem cell transplantation (ASCT). Several studies with lenalidomide have been found to have activity in the treatment of relapsed/refractory aggressive lymphomas. In the present phase I/II, single-arm, open-label study, 59 patients with high-risk relapsed non-Hodgkin lymphoma received pretransplant BEAM chemotherapy and ASCT followed by 12 months of maintenance lenalidomide once daily on Days 1-21 (28-day cycles) beginning at post-transplantation Day 100. The most common histologies were mantle cell lymphoma (56%) and diffuse large B-cell lymphoma (24%). The maximum tolerated dose in the dose-finding part of the study was 15 mg, but cytopenias led to the subsequent adoption of a 10 mg dose in the final study. Sixteen patients (27%) completed 12 cycles of lenalidomide maintenance. The most common reason for discontinuation was adverse events (31%). These were primarily haematologic, and 56% of patients experienced Grade 3-4 events. Two-year PFS rates (95% CIs) were 70% (56%-80%), 45% (19%-68%) and 81% (66%-90%); 2-year OS rates (95% CIs) were 91% (80%-96%), 93% (61%-99%) and 90% (76%-96%) in all patients, patients completing and patients not completing 12-month maintenance respectively. These results do not support the use of lenalidomide maintenance in this setting.© 2023 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.