Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome

Emergent BioSolutions

Status and phase

Terminated

Phase 3

Conditions

Mycosis Fungoides

Sezary Syndrome

Treatments

Drug: HuMax-CD4 (zanolimumab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00127881

Hx-CD4-110

Details and patient eligibility

About

The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.

Enrollment

76 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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