Clinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin.
- Registration Number
- NCT00071071
- Lead Sponsor
- Genmab
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HuMax-CD4 560 mg HuMax-CD4 - HuMax-CD4 280 milligrams (mg) HuMax-CD4 -
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale Up to 20 weeks
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) From Baseline (Day 0) up to end of study (Week 20) Percentage of Participants With Physician's Global Assessment of Clinical Condition (PGA) Response at Weeks 2, 4 and 12 At Weeks 2, 4 and 12 Percentage of Participants With Change from Baseline in Participant's Assessment of Pruritus Scale Baseline, up to Week 20 The participants were assessed pruritus on a 5-point scale from 0-4: 0. No complaint of itching on lesion; 1. Mild: Occasional transient itching on lesion; 2. Moderate: Frequent itching, every 1-3 hours; reflex scratching; 3. Severe: Compelling itching; interrupts daily activities; must be scratched; 4. Very severe: Unrelieved itching: prevents routine activities; awakens patient from sleep.
Time to Response From first dose to achieving a response (up to approximately 11 weeks) Response Duration From achieving first response to last response/until relapse (up to approximately 92 weeks) Time to Disease Progression From first dose until disease progressed (Up to 20 weeks) Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA) Baseline up to Week 20 Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres Up to Week 20
Trial Locations
- Locations (2)
Stanford University Med. Ctr., Dept. of Dermatology
🇺🇸Stanford, California, United States
University of Texas, M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States