Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome - Tabular View

Tracking Information
First Received Date ^ICMJE	August 8, 2005
Last Updated Date	November 11, 2008
Start Date ^ICMJE	July 2005
Estimated Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 11, 2008)	PGA Score [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00127881 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome
Official Title ^ICMJE	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
Brief 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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Mycosis Fungoides Sezary Syndrome
Intervention ^ICMJE	Drug: HuMax-CD4 (zanolimumab)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	92
Completion Date
Estimated Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, France, Germany, Italy, Spain

Administrative Information
NCT ID ^ICMJE	NCT00127881
Responsible Party	Project Manager, Genmab A/S
Study ID Numbers ^ICMJE	Hx-CD4-110
Study Sponsor ^ICMJE	Genmab
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Genmab
Verification Date	November 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP