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

NCT00071084 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-04-28

No results posted yet for this study

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.

Conditions

  • Cutaneous T-Cell Lymphoma

Interventions

DRUG

HuMax-CD4

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

DRUG

HuMax-CD4

HuMax-CD4 980 mg was administered as a SC infusion OD up to 16 weeks.

Sponsors & Collaborators

  • Genmab

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-27
Primary Completion
2004-06-29
Completion
2004-06-29
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00071084 on ClinicalTrials.gov