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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HuMax-CD4 280 milligrams (mg) | Experimental |
| |
| HuMax-CD4 560 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HuMax-CD4 | Drug | HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 18 weeks. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | From Baseline (Day 0) up to end of study (Week 20) | |
| Percentage of Participants With Physician's Global Assessment of Clinical Condition (PGA) Response at Weeks 2, 4 and 12 | At Weeks 2, 4 and 12 |
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Inclusion criteria
Exclusion Criteria
Note: Other protocol defined Inclusion and Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Med. Ctr., Dept. of Dermatology | Stanford | California | 94305-5152 | United States | ||
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| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D012878 | Skin Neoplasms |
| D008223 | Lymphoma |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C520522 | zanolimumab |
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| HuMax-CD4 | Drug | HuMax-CD4 560 mg was administered as a SC infusion OD up to 18 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 11 weeks) |
| Response Duration | From achieving first response to last response/until relapse (up to approximately 92 weeks) |
| Time to Disease Progression | From first dose until disease progressed (Up to 20 weeks) |
| Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA) | Baseline up to Week 20 |
| Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres | Up to Week 20 |
| University of Texas, M.D. Anderson Cancer Center |
| Houston |
| Texas |
| 77030-4009 |
| United States |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |