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An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma

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Witzig, T.E., Vose, J.M., Zinzani, P.L., Reeder, C.B., Buckstein, R., Polikoff, J.A., Bouabdallah, R., Haioun, C., Tilly, H., Guo, P., Pietronigro, D., Ervin-Haynes, A.L., Czuczman, M.S.·2011·Annals of Oncology

Abstract

BACKGROUND: Lenalidomide is an immunomodulatory agent with antitumor activity in B-cell malignancies. This phase II trial aimed to demonstrate the safety and efficacy of lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), follicular grade 3 lymphoma (FL-III), or transformed lymphoma (TL). METHODS: Patients received oral lenalidomide 25 mg on days 1-21 every 28 days as tolerated or until progression. The primary end point was overall response rate (ORR). RESULTS: Two hundred and seventeen patients enrolled and received lenalidomide. The ORR was 35% (77/217), with 13% (29/217) complete remission (CR), 22% (48/217) partial remission, and 21% (45/217) with stable disease. The ORR for DLBCL was 28% (30/108), 42% (24/57) for MCL, 42% (8/19) for FL-III, and 45% (15/33) for TL. Median progression-free survival for all 217 patients was 3.7 months [95% confidence interval (CI) 2.7-5.1]. For 77 responders, the median response duration lasted 10.6 months (95% CI 7.0-NR). Median response duration was not reached in 29 patients who achieved a CR and in responding patients with FL-III or MCL. The most common adverse event was myelosuppression with grade 4 neutropenia and thrombocytopenia in 17% and 6%, respectively. CONCLUSION: Lenalidomide is well tolerated and produces durable responses in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma.

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Metadata

Authors
Witzig, T. E., Vose, J. M., Zinzani, P. L., Reeder, C. B., Buckstein, R., Polikoff, J. A., Bouabdallah, R., Haioun, C., Tilly, H., Guo, P., Pietronigro, D., Ervin-Haynes, A. L., & Czuczman, M. S.
Venue
Annals of Oncology
Publisher
Elsevier BV
Published
2011-07
Volume
22
Issue
7
Pages
1622-1627
ISSN
0923-7534 (ISSN-L)
OpenAlex
W2096764404
Cited by
392
References
3
FWCI
27.61
Type
journal article
Language
en
Open access
hybrid

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CoChat. (2026). Citation check: An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma. https://app.cochat.ai/papers/10.1093/annonc/mdq626
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Witzig, T. E., Vose, J. M., Zinzani, P. L., Reeder, C. B., Buckstein, R., Polikoff, J. A., Bouabdallah, R., Haioun, C., Tilly, H., Guo, P., Pietronigro, D., Ervin-Haynes, A. L., & Czuczman, M. S. (2011). An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma. Annals of Oncology. https://doi.org/10.1093/annonc/mdq626

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.