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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00071084
Other study ID # Hx-CD4-008
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 27, 2003
Est. completion date June 29, 2004

Study information

Verified date April 2023
Source Genmab
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
HuMax-CD4
HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 16 weeks.
HuMax-CD4
HuMax-CD4 980 mg was administered as a SC infusion OD up to 16 weeks.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Genmab

Countries where clinical trial is conducted

United States,  Germany,  Sweden,  United Kingdom, 

Outcome

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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