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

An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients With Refractory or Persistent Early Stage (IA-IIA) Cutaneous T-Cell Lymphoma

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 participants 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 participants 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.

Inclusion criteria

• 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.
• Histopathological evidence of large cell transformation or poorly differentiated tumors or prior treatment with anti-CD4 monoclonal antibodies excluded participants from inclusion in the study.

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.
• 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.

Note: Other protocol defined Inclusion and Exclusion criteria may apply.