Show simple item record

dc.contributor.authorKim, Youn H
dc.contributor.authorDuvic, Madeleine
dc.contributor.authorObitz, Erik
dc.contributor.authorGniadecki, Robert
dc.contributor.authorIversen, Lars
dc.contributor.authorOsterborg, Anders
dc.contributor.authorWhittaker, Sean
dc.contributor.authorIllidge, Timothy M
dc.contributor.authorSchwarz, Thomas
dc.contributor.authorKaufmann, Roland
dc.contributor.authorCooper, Kevin
dc.contributor.authorKnudsen, Kim M
dc.contributor.authorLisby, Steen
dc.contributor.authorBaadsgaard, Ole
dc.contributor.authorKnox, Susan J
dc.date.accessioned2009-06-12T13:49:45Z
dc.date.available2009-06-12T13:49:45Z
dc.date.issued2007-06-01
dc.identifier.citationClinical efficacy of zanolimumab (HuMax-CD4): two phase 2 studies in refractory cutaneous T-cell lymphoma. 2007, 109 (11):4655-62 Blooden
dc.identifier.issn0006-4971
dc.identifier.pmid17311990
dc.identifier.doi10.1182/blood-2006-12-062877
dc.identifier.urihttp://hdl.handle.net/10541/70323
dc.description.abstractThe 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.
dc.language.isoenen
dc.subjectSkin Canceren
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAged, 80 and over
dc.subject.meshAntibodies, Monoclonal
dc.subject.meshAntigens, CD4
dc.subject.meshFemale
dc.subject.meshHumans
dc.subject.meshImmunotherapy
dc.subject.meshLymphoma, T-Cell, Cutaneous
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshMycosis Fungoides
dc.subject.meshProspective Studies
dc.subject.meshSezary Syndrome
dc.subject.meshSkin Neoplasms
dc.titleClinical efficacy of zanolimumab (HuMax-CD4): two phase 2 studies in refractory cutaneous T-cell lymphoma.en
dc.typeArticleen
dc.contributor.departmentMultidisciplinary Cutaneous Lymphoma Program, Stanford Comprehensive Cancer Center, 875 Blake Wilbur Drive, Stanford, CA 94305, USA. younkim@stanford.eduen
dc.identifier.journalBlooden
html.description.abstractThe 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.


This item appears in the following Collection(s)

Show simple item record