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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Mycosis Fungoides
Sezary Syndrome
 Drug: HuMax-CD4 (zanolimumab)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emergent Product Development Seattle LLC:

Primary Outcome Measures:
  • PGA Score [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: July 2005
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zanolimumab Drug: HuMax-CD4 (zanolimumab)
Monoclonal Antibody, 12 weekly infusions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881

  Show 35 Study Locations
Sponsors and Collaborators
Emergent Product Development Seattle LLC
  More Information

No publications provided

Responsible Party: Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier: NCT00127881     History of Changes
Other Study ID Numbers: Hx-CD4-110
Study First Received: August 8, 2005
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Emergent Product Development Seattle LLC:
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

Additional relevant MeSH terms:
Mycoses
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013