Clinical Trial of HuMax-CD4, a New Drug to Treat Advanced 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

NCT00071084

Hx-CD4-008

Details and patient eligibility

About

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.

Enrollment: 22 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

HuMax-CD4 280 milligrams (mg)

Experimental group

Treatment:

Drug: HuMax-CD4

Drug: HuMax-CD4

HuMax-CD4 980 mg

Experimental group

Treatment:

Drug: HuMax-CD4

Drug: HuMax-CD4