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

This study has been terminated.
(New sponsor, other treatments available)
Sponsor:
Information provided by (Responsible Party):
Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier:
NCT00127881
First received: August 8, 2005
Last updated: July 24, 2012
Last verified: July 2012

August 8, 2005
July 24, 2012
July 2005
February 2014   (final data collection date for primary outcome measure)
PGA Score [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00127881 on ClinicalTrials.gov Archive Site
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Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Mycosis Fungoides
  • Sezary Syndrome
Drug: HuMax-CD4 (zanolimumab)
Monoclonal Antibody, 12 weekly infusions.
Experimental: Zanolimumab
Intervention: Drug: HuMax-CD4 (zanolimumab)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
76
Not Provided
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Italy,   Spain,   Germany
 
NCT00127881
Hx-CD4-110
Yes
Emergent Product Development Seattle LLC
Emergent Product Development Seattle LLC
Not Provided
Not Provided
Emergent Product Development Seattle LLC
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP