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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Stanford University Med. Ctr., Dept. of Dermatology
Stanford, California, United States
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States
Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale
Time frame: Up to 20 weeks
Number of Participants with Adverse Events (AEs)
Time frame: 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
Time frame: At Weeks 2, 4 and 12
Percentage of Participants With Change from Baseline in Participant's Assessment of Pruritus Scale
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 frame: Baseline, up to Week 20
Time to Response
Time frame: From first dose to achieving a response (up to approximately 11 weeks)
Response Duration
Time frame: From achieving first response to last response/until relapse (up to approximately 92 weeks)
Time to Disease Progression
Time frame: From first dose until disease progressed (Up to 20 weeks)
Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA)
Time frame: Baseline up to Week 20
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Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
Time frame: Up to Week 20