Lenalidomide maintenance following high‐dose therapy and autologous haematopoietic stem cell transplantation in chemo‐resistant or high‐risk non‐Hodgkin lymphoma: A phase I/II study

Abstract

SummaryImproved 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.