Clinical Trial of HuMax-CD4, a New Drug to Treat Advanced Stage T-Cell Lymphoma in the Skin. - Tabular View

Tracking Information
First Received Date ^ICMJE	October 10, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00071084 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Clinical Trial of HuMax-CD4, a New Drug to Treat Advanced Stage T-Cell Lymphoma in the Skin.
Official Title ^ICMJE
Brief Summary	The purpose of this trial is to determine the effect of HuMax-CD4, as a treatment for advanced stage (late stage) cutaneous T-cell lymphoma (CTCL). Almost all patients who are affected by late stage CTCL have many cancerous cells which bear a receptor called CD4. HuMax-CD4 is an investigational drug directed against this receptor. There is no placebo in this trial; all patients will be treated with HuMax-CD4. The response rates, duration of responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated during this trial.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Cutaneous T-Cell Lymphoma
Intervention ^ICMJE	Drug: HuMax-CD4
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	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion criteria Medical diagnosis of CTCL, and positivity for the CD4 receptor. Late stage CTCL. Have received at least one prior anti-cancer therapy with inadequate effect. WHO performance status 0,1 or 2 Male or female, age 18 or older. Signed informed consent. Exclusion Criteria Certain rare types of CTCL. Previous treatment with other anti-CD4 medications. More than two previous treatments with systemic chemotherapy. Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial. Some types of steroid treatments less than two weeks before entering the trial. Prolonged exposure to sunlight or UV light during the trial. Other cancer diseases, except certain skin cancers or cervix cancer. Chronic infectious disease requiring medication. Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases. Certain laboratory values which are too high or too low. HIV positivity. Pregnant or breast-feeding women. Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial. If you are participating in another trial with a different new drug 4 weeks before you enter this trial.
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, Germany, Sweden, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00071084
Responsible Party
Study ID Numbers ^ICMJE	Hx-CD4-008
Study Sponsor ^ICMJE	Genmab
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Genmab
Verification Date	June 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP