CompletedPhase 2

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

United States, Germany, Sweden22 participantsStarted 2003-05-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale

Timeframe: Up to 20 weeks

Trial details

NCT IDNCT00071084

SponsorGenmab

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-06-29

View on ClinicalTrials.gov More Cutaneous T-Cell Lymphoma trials