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

Study Overview
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Brief Summary
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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.

Official Title
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Open Label, Dose Escalation, Followed by Open Label,Single Arm Clinical Trial of HuMax-CD4 in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy

Conditions
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Mycosis Fungoides, Sezary Syndrome

Intervention / Treatment
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* Drug: HuMax-CD4 (zanolimumab)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zanolimumab<br> | Drug: HuMax-CD4 (zanolimumab)<br>* Monoclonal Antibody, 12 weekly infusions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PGA Score |  | Duration of Study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory or intolerant to Mycosis Fungoides and sezary syndrome, Cutaneous T-cell Lymphoma, To evaluate the efficacy and safety of zanolimumab in Mycosis Fungoides and sezary syndrome