NCT00071071已完成2 期
An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients With Refractory or Persistent Early Stage (IA-IIA) Cutaneous T-Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Genmab
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
HuMax-CD4 280 milligrams (mg)
Experimental
干预措施: HuMax-CD4 (Drug)
HuMax-CD4 560 mg
Experimental
干预措施: HuMax-CD4 (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale
时间窗: Up to 20 weeks
次要结局
- 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)
- Percentage of Participants With Change from Baseline in Participant's Assessment of Pruritus Scale(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)
研究者
研究点 (2)
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