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

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.

• Authors: Julie M Vose, Siddhartha Ganguly, Philip J Bierman, R Gregory Bociek, Matthew Lunning, Liz Lyden, Jane L Meza, Paolo F Caimi, James O Armitage
• Journal: British journal of haematology (Br J Haematol) Vol. 202 Issue 1 Pg. 116-121 (07 2023) ISSN: 1365-2141 [Electronic] England
• PMID: 37096954 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2023 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.

Chemical References

• Lenalidomide

Topics

• Humans
• Adult
• Lenalidomide
• Lymphoma, Non-Hodgkin (drug therapy)
• Lymphoma, Mantle-Cell (drug therapy)
• Lymphoma, Large B-Cell, Diffuse (drug therapy)
• Hematopoietic Stem Cell Transplantation (adverse effects)
• Transplantation, Autologous
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Treatment Outcome