Clinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this trial is to determine the effect of HuMax-CD4 as a treatment for early stage cutaneous T-cell lymphoma (CTCL). Almost all patients who are affected by CTCL have 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. During the trial, the response rates, duration of responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Medical diagnosis of CTCL, and positivity for the CD4 receptor.
Early stage CTCL
Have received at least two prior therapies with inadequate effect, including phototherapy and/or electron beam, and/or chemotherapy.
Male or female, age 18 or older.
Signed informed consent.
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.
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.