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| Sponsor: | Genmab |
|---|---|
| Information provided by: | Genmab |
| ClinicalTrials.gov Identifier: | NCT00071084 |
Purpose
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 |
|---|---|---|
|
Cutaneous T-Cell Lymphoma |
Drug: HuMax-CD4 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion Criteria
Contacts and Locations| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00071084 History of Changes |
| Other Study ID Numbers: | Hx-CD4-008 |
| Study First Received: | October 10, 2003 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Skin cancer Lymphoma Mycosis fungoides Sezary syndrome |
|
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |