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Sponsored by: |
Genmab |
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Information provided by: | Genmab |
ClinicalTrials.gov Identifier: | NCT00071084 |
The purpose of this trial is to determine the effect of HuMax-CD4, as a treatment for advanced stage (late stage) cutaneous T-cell lymphoma (CTCL).
Almost all patients who are affected by late stage CTCL have many cancerous cells which bear a receptor called CD4. HuMax-CD4 is an investigational drug directed against this receptor. There is no placebo in this trial; all patients will be treated with HuMax-CD4. The response rates, duration of responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated during this trial.
Condition | Intervention | Phase |
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Cutaneous T-Cell Lymphoma |
Drug: HuMax-CD4 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion Criteria
United States, California | |
Stanford University Med Ctr., Dept of Dermatology | |
Stanford, California, United States, 94305-5152 | |
United States, Texas | |
University of Texas, M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 | |
Germany | |
MÜNSTER, Germany | |
Sweden | |
Stockholm, Sweden | |
United Kingdom | |
London, United Kingdom |
Study ID Numbers: | Hx-CD4-008 |
Study First Received: | October 10, 2003 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00071084 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Skin cancer Lymphoma Mycosis fungoides Sezary syndrome |
Lymphatic Diseases Mycoses Immunoproliferative Disorders Cutaneous T-cell Lymphoma Lymphoma, T-Cell Sezary Syndrome |
Mycosis Fungoides Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Skin Neoplasms Lymphoma Lymphoma, T-Cell, Cutaneous |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Lymphoma, T-Cell |
Sezary Syndrome Mycosis Fungoides Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |