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Prepublished online as a Blood First Edition Paper on January 23, 2003; DOI 10.1182/blood-2002-09-2802. This Article Full Text Full Text (PDF) All Versions of this Article: 2002-09-2802v1 101/11/4267    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Lundin, J. Articles by Österborg, A. Search for Related Content PubMed PubMed Citation Articles by Lundin, J. Articles by Österborg, A. Related Collections Neoplasia Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  Blood, 1 June 2003, Vol. 101, No. 11, pp. 4267-4272 CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sézary syndrome Jeanette Lundin, Hans Hagberg, Roland Repp, Eva Cavallin-Ståhl, Susanne Fredén, Gunnar Juliusson, Eija Rosenblad, Geir Tjønnfjord, Tom Wiklund, and Anders Österborg From the Departments of Hematology/Oncology and Dermatology, Karolinska Hospital, Stockholm, Sweden; Departments of Oncology/Hematology, Uppsala University Hospital, Sweden; University of Erlangen, Germany; Lund University Hospital, Sweden; Ryhov Hospital, Jgönköping, Sweden; Linköping University Hospital, Sweden; Rikshospitalet, Oslo, Norway; and Helsinki University Hospital, Finland. This phase 2 study evaluated the safety and efficacy of alemtuzumab in 22 patients with advanced mycosis fungoides/Sézary syndrome (MF/SS). Most patients had stage III or IV disease, reduced performance status, and severe itching. The overall response (OR) rate was 55%, with 32% of patients in complete remission (CR) and 23% in partial remission (PR). Sézary cells were cleared from the blood in 6 of 7 (86%) patients, and CR in lymph nodes was observed in 6 of 11 (55%) patients. The effect was better on erythroderma (OR, 69%) than on plaque or skin tumors (OR, 40%) and in patients who had received 1 to 2 previous regimens (OR, 80%) than in those who had received 3 or more prior regimens (OR, 33%). Itching, self-assessed on a 0 to 10 visual analog scale, was reduced from a median of 8 before treatment to 2 at end of therapy. Median time to treatment failure was 12 months (range, 5-32+ months). Cytomegalovirus (CMV) reactivation (causing fever without pneumonitis and responding to ganciclovir) occurred in 4 (18%) patients. Six additional patients had suspect or manifest infection (fever of unknown origin, 3; generalized herpes simplex, 1; fatal aspergillosis, 1). One patient had fatal Mycobacterium pneumonia at 10+ months. All serious infectious adverse events (except CMV) occurred in patients who had received 3 or more prior regimens. Progression of squamous cell skin carcinoma was noted in 1 patient. Alemtuzumab shows promising clinical activity and an acceptable safety profile in patients with advanced MF/SS, particularly in patients with erythroderma and severe itching and those who were not heavily pretreated. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: A. Gallamini, F. Zaja, C. Patti, A. Billio, M. R. Specchia, A. Tucci, A. Levis, A. Manna, V. Secondo, L. Rigacci, et al. Alemtuzumab (Campath-1H) and CHOP chemotherapy as first-line treatment of peripheral T-cell lymphoma: results of a GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) prospective multicenter trial Blood, October 1, 2007; 110(7): 2316 - 2323. [Abstract] [Full Text] [PDF] M. G. Bernengo, P. Quaglino, A. Comessatti, M. Ortoncelli, M. Novelli, F. Lisa, and M. T. Fierro Low-dose intermittent alemtuzumab in the treatment of Sezary syndrome: clinical and immunologic findings in 14 patients Haematologica, June 1, 2007; 92(6): 784 - 794. [Abstract] [Full Text] [PDF] Y. H. Kim, M. Duvic, E. Obitz, R. Gniadecki, L. Iversen, A. Osterborg, S. Whittaker, T. M. Illidge, T. Schwarz, R. Kaufmann, et al. Clinical efficacy of zanolimumab (HuMax-CD4): two phase 2 studies in refractory cutaneous T-cell lymphoma Blood, June 1, 2007; 109(11): 4655 - 4662. [Abstract] [Full Text] [PDF] S. Pulini, S. Rupoli, G. Goteri, N. Pimpinelli, R. Alterini, A. Tassetti, A. R. Scortechini, M. Offidani, S. 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