Clinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin.
NCT00071071 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2023-05-18
Summary
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 participants 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 participants 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.
Conditions
- Cutaneous T-Cell Lymphoma
Interventions
- DRUG
-
HuMax-CD4
HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 18 weeks.
- DRUG
-
HuMax-CD4
HuMax-CD4 560 mg was administered as a SC infusion OD up to 18 weeks.
Sponsors & Collaborators
-
Genmab
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-04-30
- Primary Completion
- 2004-05-05
- Completion
- 2004-05-05
- FDA Drug
- Yes
Countries
- United States
Study Locations
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