Long-term follow-up of lenalidomide in relapsed/ refractory mantle cell lymphoma: Subset analysis of the NHL-003 study

P. L. Zinzani, J. M. Vose, M. S. Czuczman, C. B. Reeder, C. Haioun, J. Polikoff, H. Tilly, L. Zhang, K. Prandi, J. Li, T. E. Witzig

Research output: Contribution to journalArticlepeer-review

86 Scopus citations


Background: Mantle cell lymphoma (MCL) is an uncommon type of non-Hodgkin lymphoma with poor overall prognosis, requiring the development of new therapies. Lenalidomide is an immunomodulatory agent demonstrating antitumor and antiproliferative effects in MCL. We report results from a long-term subset analysis of 57 patients with relapsed/refractory MCL from the NHL-003 phase II multicenter study of single-agent lenalidomide in patients with aggressive lymphoma Design: Lenalidomide was administered orally 25 mg daily on days 1-21 every 28 days until progressive disease (PD) or intolerability. The primary end point was overall response rate (ORR). Results: Fifty-seven patients with relapsed/refractory, advanced-stage MCL had a median of three prior therapies. The ORR was 35% [complete response (CR)/CR unconfirmed (CRu) 12%], with a median duration of response (DOR) of 16.3 months (not yet reached in patients with CR/CRu) by blinded independent central review. The median time to first response was 1.9 months. Median progression-free survival was 8.8 months, and overall survival had not yet been reached. The most common grade 3/4 adverse events (AEs) were neutropenia (46%), thrombocytopenia (30%), and anemia (13%). Conclusions: These results show the activity of lenalidomide in heavily pretreated, relapsed/refractory MCL. Responders had a durable response with manageable side-effects. Clinical trial number posted on www.clinicaltrials.gov NCT00413036.

Original languageEnglish (US)
Pages (from-to)2892-2897
Number of pages6
JournalAnnals of Oncology
Issue number11
StatePublished - Nov 2013


  • Lenalidomide
  • Mantle cell lymphoma
  • Non-Hodgkin lymphoma

ASJC Scopus subject areas

  • Hematology
  • Oncology


Dive into the research topics of 'Long-term follow-up of lenalidomide in relapsed/ refractory mantle cell lymphoma: Subset analysis of the NHL-003 study'. Together they form a unique fingerprint.

Cite this