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Completed

NCT Number: NCT00071084

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

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.

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Key information

Conditions

Cutaneous T-Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Mycosis Fungoides Neoplasms Neoplasms by Histologic Type Neoplasms by Site Sezary Syndrome Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Münster, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HuMax-CD4

Drug

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

Other names: Zanolimumab

Primary outcomes

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

    Time frame: Up to 20 weeks

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs) and Graded as per Severity

    Time frame: From Baseline (Day 0) up to end of study (Week 20)

  2. Percentage of Participants With Physician's Global Assessment of Clinical Condition (PGA) Response

    Time frame: Up to 20 weeks

  3. Percentage of Participants with Change from Baseline in Participant's Assessment of Pruritus Scale

    Time frame: Baseline, up to Week 20

    The participants were assessed pruritus on a 5-point scale from 0-4: 0. No complaint of itching on lesion; 1. Mild: Occasional transient itching on lesion; 2. Moderate: Frequent itching, every 1-3 hours; reflex scratching; 3. Severe: Compelling itching; interrupts daily activities; must be scratched; 4. Very severe: Unrelieved itching: prevents routine activities; awakens patient from sleep.

  4. Time to Response

    Time frame: From first dose to achieving a response (up to approximately 12 weeks)

  5. Response Duration

    Time frame: From achieving first response to last response/until relapse (up to approximately 22 weeks)

  6. Time to Disease Progression

    Time frame: From first dose until disease progressed (Up to 16 weeks)

  7. Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA)

    Time frame: Baseline up to Week 21

  8. Change from Baseline in Physician's Erythroderma Severity Assessment

    Time frame: Baseline, Week 20

  9. Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres

    Time frame: Up to Week 20

Sponsors and collaborators

Lead sponsor

Genmab

Industry

Registry information

Official study title

An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients With Advanced Stage (IIA-IVB) Cutaneous T-cell Lymphoma

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Oct 15, 2003
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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