Lenalidomide maintenance is not recommended for patients receiving high-dose therapy and autologous hematopoietic stem cell transplantation (HDT/ASCT) for chemotherapy-resistant or high-risk non-Hodgkin lymphoma, according to research published in the British Journal of Haematology.

Although previous research has suggested that maintenance lenalidomide may improve outcomes among patients with some lymphoma subtypes that receive HDT/ASCT, the utility of this strategy in the wider non-Hodgkin lymphoma setting was previously unknown.

For this single-arm phase 1/2 study (ClinicalTrials.gov Identifier: NCT01035463), researchers aimed to apply this paradigm in the chemotherapy-resistant or high-risk non-Hodgkin lymphoma and evaluated the safety and efficacy of maintenance lenalidomide following HDT/ASCT in this patient population. All included patients who were enrolled received combination carmustine, etoposide, cytarabine, and melphalan and ASCT; the study’s aim was to provide 12 months of maintenance lenalidomide.

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Overall, 59 patients were included, of whom 16 completed 12 months of maintenance while 43 did not. In the overall cohort, the median age was 59 years, 71% of patients were male sex, 97% of patients were White, and the most common tumor histology was mantle cell lymphoma (56% of patients).

In the study’s dose-finding part, the maximum tolerated dose was 15 mg, which was lowered to 10 mg in the final study because of cytopenias. Adverse events (31% of discontinuations) were the most common reason for stopping therapy prior to 12 months. In the overall cohort, 56% of patients had a grade 3 to 4 adverse event.

Analysis showed that, among patients who completed vs did not complete 12 months of maintenance, 2-year PFS rates were 70% and 81%, respectively; 2-year overall survival rates were 91% and 90%.

The authors wrote that “only a modest number of patients were able to finish the 12 months of maintenance and there was not a control arm for comparison.

“Bearing this in mind, these results, while not definitive, do not support the use of 12-month lenalidomide maintenance in patients with high-risk [non-Hodgkin lymphoma] in the post-ASCT setting,” they noted in their report.

Disclosures: This research was supported by Bristol-Meyers Squibb. Please see the original reference for a full list of disclosures.


Vose JM, Ganguly S, Bierman PJ, et al. 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. Br J Haematol. Published online April 25, 2023. doi:10.1111/bjh.18821