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Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome
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2003 (English)In: Blood, ISSN 0006-4971, E-ISSN 1528-0020, Vol. 101, no 11, 4267-4272 p.Article in journal (Refereed) Published
Abstract [en]

This phase 2 study evaluated the safety and efficacy of alemtuzumab in 22 patients with advanced mycosis fungoides/Sezary 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 M in, partial remission (PR). Sezary 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 erythro-derma (OR, 69%) than on plaque or skin tumors (OR, 40%) and in patients who had received 1 to 2 previous regimens (OR, 80%) thin 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. (C) 2003 by The American Society of Hematology.

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2003. Vol. 101, no 11, 4267-4272 p.
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Medical and Health Sciences
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URN: urn:nbn:se:liu:diva-47796DOI: 10.1182/blood-2002-09-2802OAI: oai:DiVA.org:liu-47796DiVA: diva2:268692
Available from: 2009-10-11 Created: 2009-10-11 Last updated: 2017-12-13

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Juliusson, Gunnar

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