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Abstract
The activity and safety of a regimen combining lenalidomide with fludarabine and cyclophosphamide (FC) was investigated in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Treatment consisted of six monthly courses of the FC regimen combined with 14 days of lenalidomide given at the starting dose of 2.5 mg during course 1. The maximum tolerated dose of lenalidomide was 5 mg. Forty patients were assessed for response, 66% were IGHV unmutated, 45% showed deletion 11q or 17p. The overall response and complete remission rates were 62.5% and 22.5%, respectively, the median progression-free and overall survival (OS) were 19 and 45 months, respectively. Grade 3–4 granulocytopenia was observed in 65% of cases, severe infections in 7.5%, the lenalidomide-related toxicity was mild. In conclusion, the results of this study demonstrate that low-dose lenalidomide associated with the FC schedule is an effective treatment for R/R patients with CLL, associated with an acceptable safety profile.
Acknowledgments
Work partly supported by Associazione Italiana per la Ricerca sul Cancro (AIRC) Special Program Molecular Clinical Oncology, 5x1000, MCO1007 (to RF), Milan, Italy; Ministero dell’Università e Ricerca (MIUR), Fondo per gli Investimenti della Ricerca di Base (FIRB), Rome, Italy; Progetti di Ateneo Sapienza Università di Roma, 2015 (#C26A15F9WW); Progetto Giovani Ricercatori 2010: Policlinico di Modena (#GR-2010-2313609). We wish to thank the patients who agreed to participate in this study and Celgene who provided lenalidomide and a research grant to GIMEMA.
Potential conflict of interest
Disclosure forms provided by the authors are available with the full text of this article online at http://dx.doi.org/10.1080/10428194.2016.1258698.