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Sponsored by: |
Genmab |
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Information provided by: | Genmab |
ClinicalTrials.gov Identifier: | NCT00071071 |
The purpose of this trial is to determine the effect of HuMax-CD4 as a treatment for early stage cutaneous T-cell lymphoma (CTCL). Almost all patients who are affected by CTCL have 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. During the trial, the response rates, duration of responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated.
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 |
Study ID Numbers: | Hx-CD4-007 |
Study First Received: | October 10, 2003 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00071071 |
Health Authority: | United States: Food and Drug Administration |
Skin cancer Lymphoma Mycosis fungoides Sezary syndrome |
Sezary syndrome Immunoproliferative Disorders Cutaneous T-cell lymphoma Sezary Syndrome Mycosis Fungoides Skin Neoplasms Mycoses |
Lymphatic Diseases Lymphoma, T-Cell Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Lymphoma, T-Cell, Cutaneous |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |