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Therapeutic Areas: Immunology/Infectious Diseases | Oncology
Disease Category: Cutaneous T-Cell Lymphoma

Trial Information

If you have mycosis fungoides type CTCL and have experienced treatment failure or lack of tolerance with systemic or skin directed treatments you may be eligible for this clinical trial.

Physicians are currently seeking subjects to participate in this open-label, dose-escalation, followed by double-blind, randomized clinical research study of an investigational agent. Eligible subjects will receive weekly IV infusions of the investigational agent. Subjects are asked to come to the clinic for at least 16 visits during a 22 week period.

Qualified subjects receive all evaluations and procedures related to the study at no cost, including physical examinations, laboratory tests, ECG, and CT-scan. Blood draws and biopsies will be done periodically.

Inclusion Criteria includes:

• Biopsy proven MF with a CD4 positive phenotype
• MF stage IB to IVB
• Refractory or intolerant to at least two prior therapies
• Male or female, at least 18 years of age
• Signed informed consent

Exclusion Criteria includes:

• Sezary syndrome
• Prior treatment with combination chemotherapy within six months
• Prior treatment with Total Skin Electron Beam (TSEB) therapy within one year
• Prior treatment with Campath (alemtuzumab)
• Prior treatment with more than three regimens of single agent chemotherapy
• Treatment within 4 weeks prior to study with topical Targretin®, skin directed therapies or systemic anticancer therapies.
• Most past or current cancers
• Serious intercurrent medical condition
• Acute or chronic infectious disease
• Breast feeding women or women with a positive pregnancy test
• Patients of childbearing potential must practice adequate contraception

For more information,

Oregon Health & Science University
Located in:
Portland, OR 97239
Phone: 1-866-887-1291
EMail: mf@us.genmab.com

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