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

Genmab

Status and phase

Completed

Phase 2

Conditions

Cutaneous T-Cell Lymphoma

Treatments

Drug: HuMax-CD4

Study type

Interventional

Funder types

Industry

Identifiers

NCT00071071

Hx-CD4-007

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Medical diagnosis of CTCL, and positivity for the CD4 receptor.
Early stage CTCL
Have received at least two prior therapies with inadequate effect, including phototherapy and/or electron beam, and/or chemotherapy.
Histopathological evidence of large cell transformation or poorly differentiated tumors or prior treatment with anti-CD4 monoclonal antibodies excluded participants from inclusion in the study.

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.