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    Clinical efficacy of zanolimumab (HuMax-CD4): two phase 2 studies in refractory cutaneous T-cell lymphoma.

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    Authors
    Kim, Youn H
    Duvic, Madeleine
    Obitz, Erik
    Gniadecki, Robert
    Iversen, Lars
    Osterborg, Anders
    Whittaker, Sean
    Illidge, Timothy M
    Schwarz, Thomas
    Kaufmann, Roland
    Cooper, Kevin
    Knudsen, Kim M
    Lisby, Steen
    Baadsgaard, Ole
    Knox, Susan J
    Show allShow less
    Affiliation
    Multidisciplinary Cutaneous Lymphoma Program, Stanford Comprehensive Cancer Center, 875 Blake Wilbur Drive, Stanford, CA 94305, USA. younkim@stanford.edu
    Issue Date
    2007-06-01
    
    Metadata
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    Abstract
    The efficacy and safety of zanolimumab in patients with refractory cutaneous T-cell lymphoma (CTCL) have been assessed in two phase 2, multicenter, prospective, open-label, uncontrolled clinical studies. Patients with treatment refractory CD4(+) CTCL (mycosis fungoides [MF], n = 38; Sézary syndrome [SS], n = 9) received 17 weekly infusions of zanolimumab (early-stage patients, 280 and 560 mg; advanced-stage patients, 280 and 980 mg). The primary end point was objective response (OR) as assessed by composite assessment of index lesion disease activity score. Secondary end points included physician's global assessment (PGA), time to response, response duration, and time to progression. ORs were recorded for patients in both CTCL types (MF, 13 ORs; SS, 2 ORs). In the high-dose groups (560 and 980 mg dose groups), a response rate of 56% was obtained with a median response of 81 weeks. Adverse events reported most frequently included low-grade infections and eczematous dermatitis. Zanolimumab showed marked clinical efficacy in the treatment of patients with refractory MF, with early onset of response, high response rate, and durable responses. The treatment was well tolerated with no dose-related toxicity other than the targeted depletion of peripheral T cells. A pivotal study has been initiated based on these findings.
    Citation
    Clinical efficacy of zanolimumab (HuMax-CD4): two phase 2 studies in refractory cutaneous T-cell lymphoma. 2007, 109 (11):4655-62 Blood
    Journal
    Blood
    URI
    http://hdl.handle.net/10541/70323
    DOI
    10.1182/blood-2006-12-062877
    PubMed ID
    17311990
    Type
    Article
    Language
    en
    ISSN
    0006-4971
    ae974a485f413a2113503eed53cd6c53
    10.1182/blood-2006-12-062877
    Scopus Count
    Collections
    All Paterson Institute for Cancer Research

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