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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cutaneous T-Cell Lymphoma

Intervention / Treatment
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* Drug: HuMax-CD4
* Drug: HuMax-CD4


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HuMax-CD4 280 milligrams (mg)<br> | Drug: HuMax-CD4<br>* HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 16 weeks.<br>* Other names: Zanolimumab;|
| Experimental: HuMax-CD4 980 mg<br> | Drug: HuMax-CD4<br>* HuMax-CD4 980 mg was administered as a SC infusion OD up to 16 weeks.<br>* Other names: Zanolimumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale |  | Up to 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) and Graded as per Severity |  | From Baseline (Day 0) up to end of study (Week 20) | 
| Percentage of Participants With Physician's Global Assessment of Clinical Condition (PGA) Response |  | Up to 20 weeks | 
| Percentage of Participants with Change from Baseline in Participant's Assessment of Pruritus Scale | 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. | Baseline, up to Week 20 | 
| Time to Response |  | From first dose to achieving a response (up to approximately 12 weeks) | 
| Response Duration |  | From achieving first response to last response/until relapse (up to approximately 22 weeks) | 
| Time to Disease Progression |  | From first dose until disease progressed (Up to 16 weeks) | 
| Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA) |  | Baseline up to Week 21 | 
| Change from Baseline in Physician's Erythroderma Severity Assessment |  | Baseline, Week 20 | 
| Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres |  | Up to Week 20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin cancer, Lymphoma, Mycosis fungoides, Sezary syndrome