Cutaneous T-Cell Lymphoma Clinical Trial
Official title:
An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients With Advanced Stage (IIA-IVB) Cutaneous T-cell Lymphoma
Verified date | April 2023 |
Source | Genmab |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 participants 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 participants 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.
Status | Completed |
Enrollment | 22 |
Est. completion date | June 29, 2004 |
Est. primary completion date | June 29, 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria - Medical diagnosis of CTCL, and positivity for the CD4 receptor. - Late stage CTCL. - Have received at least one prior anti-cancer therapy with inadequate effect. - World Health Organization (WHO) performance status 0,1 or 2 Exclusion Criteria - Certain rare types of CTCL. - Previous treatment with other anti-CD4 medications. - More than two previous treatments with systemic chemotherapy. - Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial. - Some types of steroid treatments less than two weeks before entering the trial. - Prolonged exposure to sunlight or UV light during the trial. - Other cancer diseases, except certain skin cancers or cervix cancer. - Chronic infectious disease requiring medication. - Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases. - Pregnant or breast-feeding women. - Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial. - If you are participating in another trial with a different new drug 4 weeks before you enter this trial. Note: Other protocol defined Inclusion and Exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas, M.D. Anderson Cancer Center | Houston | Texas |
United States | Stanford University Med Ctr., Dept of Dermatology | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Genmab |
United States, Germany, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of Participants with Adverse Events (AEs) and Graded as per Severity | From Baseline (Day 0) up to end of study (Week 20) | ||
Secondary | Percentage of Participants With Physician's Global Assessment of Clinical Condition (PGA) Response | Up to 20 weeks | ||
Secondary | 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. | Baseline, up to Week 20 | |
Secondary | Time to Response | From first dose to achieving a response (up to approximately 12 weeks) | ||
Secondary | Response Duration | From achieving first response to last response/until relapse (up to approximately 22 weeks) | ||
Secondary | Time to Disease Progression | From first dose until disease progressed (Up to 16 weeks) | ||
Secondary | Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA) | Baseline up to Week 21 | ||
Secondary | Change from Baseline in Physician's Erythroderma Severity Assessment | Baseline, Week 20 | ||
Secondary | Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres | Up to Week 20 |
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