Cutaneous T-Cell Lymphoma
Conditions
Keywords
Skin cancer, Lymphoma, Mycosis fungoides, Sezary syndrome
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.
Interventions
DRUGHuMax-CD4
HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 18 weeks.
Sponsors
Genmab
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Note: Other protocol defined Inclusion and
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Percentage of Participants With Change from Baseline in Participant's Assessment of Pruritus Scale | 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. |
| Time to Response | From first dose to achieving a response (up to approximately 11 weeks) | — |
| Number of Participants with Adverse Events (AEs) | From Baseline (Day 0) up to end of study (Week 20) | — |
| 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 | — |
| Response Duration | From achieving first response to last response/until relapse (up to approximately 92 weeks) | — |
Countries
United States
Outcome results
None listed