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

NCT ID: NCT00071071

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2004-05-05

Brief Summary

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.

Conditions

Cutaneous T-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HuMax-CD4 280 milligrams (mg)

Group Type: EXPERIMENTAL

HuMax-CD4

Intervention Type: DRUG

HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 18 weeks.

HuMax-CD4 560 mg

Group Type: EXPERIMENTAL

HuMax-CD4

Intervention Type: DRUG

HuMax-CD4 560 mg was administered as a SC infusion OD up to 18 weeks.

Interventions

HuMax-CD4

HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 18 weeks.

Intervention Type: DRUG

HuMax-CD4

HuMax-CD4 560 mg was administered as a SC infusion OD up to 18 weeks.

Intervention Type: DRUG

Other Intervention Names

Zanolimumab; Zanolimumab

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genmab

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford University Med. Ctr., Dept. of Dermatology

Stanford, California, United States

University of Texas, M.D. Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

Hx-CD4-007

Identifier Type: -

Identifier Source: org_study_id