Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Emergent Product Development Seattle LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome
