Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome - Full Text View

Sponsored by:	Genmab
Information provided by:	Genmab
ClinicalTrials.gov Identifier:	NCT00127881

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open Label, Dose Escalation, Followed by Open Label,Single Arm, Multi-Center Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, 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:

MedlinePlus related topics: Fungal Infections Lymphoma

Drug Information available for: Immunoglobulins Zanolimumab Globulin, Immune

U.S. FDA Resources

Further study details as provided by Genmab:

Primary Outcome Measures:

PGA Score [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]

Estimated Enrollment:	92
Study Start Date:	July 2005
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Genmab

More Information

No publications provided

Responsible Party:	Genmab A/S ( Project Manager )
Study ID Numbers:	Hx-CD4-110
Study First Received:	August 8, 2005
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00127881 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Italy:; Spain:; France:; Italy:

Keywords provided by Genmab:

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

Study placed in the following topic categories:

Immunoproliferative Disorders
Immunologic Factors
Sezary Syndrome
Mycosis Fungoides
Antibodies, Monoclonal
Mycoses
Lymphatic Diseases
Antibodies

Cutaneous T-cell Lymphoma
Bexarotene
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Immunoglobulins
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:

Disease
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Sezary Syndrome
Mycosis Fungoides
Pharmacologic Actions
Antibodies, Monoclonal

Mycoses
Lymphatic Diseases
Neoplasms
Pathologic Processes
Syndrome
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on July 02, 2009