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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00127881
• Date of registration: 08/08/2005
• Prospective Registration: No
• Primary sponsor: Emergent Product Development Seattle LLC
• Public title: Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome
• Scientific title: 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
• Date of first enrolment: July 2005
• Target sample size: 76
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00127881
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France, Germany, Italy, Spain, United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Mycosis Fungoides

Sezary Syndrome

Intervention(s)

Drug: HuMax-CD4 (zanolimumab)

Primary Outcome(s)

PGA Score [Time Frame: Duration of Study]

Secondary ID(s)

Hx-CD4-110

Source(s) of Monetary Support

Please refer to primary and secondary sponsors