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Clinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin.

Phase 2
Completed
Conditions
Cutaneous T-Cell Lymphoma
Interventions
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
HuMax-CD4 560 mgHuMax-CD4-
HuMax-CD4 280 milligrams (mg)HuMax-CD4-
Primary Outcome Measures
NameTimeMethod
Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) ScaleUp to 20 weeks
Secondary Outcome Measures
NameTimeMethod
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 12At Weeks 2, 4 and 12
Percentage of Participants With Change from Baseline in Participant's Assessment of Pruritus ScaleBaseline, 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 ResponseFrom first dose to achieving a response (up to approximately 11 weeks)
Response DurationFrom achieving first response to last response/until relapse (up to approximately 92 weeks)
Time to Disease ProgressionFrom 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) TitresUp 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

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