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Trial NCT00127881

Resource URI: http://static.linkedct.org/resource/trials/NCT00127881
PropertyValue
linkedct:brief_title Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome
linkedct:condition <http://static.linkedct.org/resource/condition/12049>
linkedct:condition <http://static.linkedct.org/resource/condition/8436>
linkedct:criteria Inclusion Criteria: - A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry - Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof). - Signed informed consent Exclusion Criteria: - Prior treatment with Total Skin Electron Beam (TSEB) therapy within six months - Prior treatment with Campath (alemtuzumab) - Prior treatment with more than three regimens of single agent chemotherapy - Prior treatment with pentostatin within 6 months - Treatment within 4 weeks prior to visit 2 with topical Targretin®, skin directed therapies or systemic anticancer therapies, such as, but not limited to: Targretin® , UV-light therapy, local Electron Beam Therapy (EBT), extracorporal photo chemotherapy, methotrexate, bleomycin, cyclophosphamide, combination chemotherapy, oral retinoids, systemic glucocorticosteroids , carmustine, nitrogen mustard, systemic vitamin A or etretinate - Treatment with topical glucocorticosteroids within 2 weeks prior to visit 2 - Unwillingness or inability to avoid prolonged exposure to the sun or UV light sufficient to produce a mild erythema or thought by the investigator to likely modify the patient's disease - Concurrent or previous malignancies within the past five years except adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell skin carcinoma - Significant concurrent, uncontrolled, or active medical condition including, but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease - Known or suspected positive serology for HIV - Known or suspected positive serology for hepatitis B or C - Patients who are currently participating in any other trials or having received treatment with any experimental agent within 4 weeks prior to visit 1 (screening) - Prior treatment with anti-CD4 monoclonal antibodies - Breast feeding women or women with a positive pregnancy test at Visit 1 - Women of childbearing potential not willing to use either hormonal birth control, an intrauterine device or double-barrier method for the entire study period
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 92 (xsd:int)
linkedct:firstreceived_date August 8, 2005
linkedct:has_dmc Yes
linkedct:id NCT00127881
linkedct:intervention <http://static.linkedct.org/resource/intervention/88312>
rdfs:label Trial NCT00127881
linkedct:lastchanged_date November 11, 2008
linkedct:lead_sponsor_agency Genmab
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linkedct:nct_id NCT00127881
linkedct:number_of_arms 1 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Open Label, Dose Escalation, Followed by Open Label,Single Arm, Multi-Center Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy
linkedct:org_study_id Hx-CD4-110
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/1106>
linkedct:oversight <http://static.linkedct.org/resource/oversight/1473>
linkedct:oversight <http://static.linkedct.org/resource/oversight/2404>
linkedct:oversight <http://static.linkedct.org/resource/oversight/2920>
linkedct:oversight <http://static.linkedct.org/resource/oversight/863>
foaf:page <http://clinicaltrials.gov/show/NCT00127881>
linkedct:phase Phase 3
linkedct:primary_completion_date February 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/61931>
linkedct:source Genmab
linkedct:start_date July 2005
linkedct:study_design Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
rdf:type linkedct:trials
linkedct:verification_date November 2008