NCT04745234进行中（未招募）2 期
Open-Label, Phase 2 Study to Assess the Safety of Mogamulizumab Given Every 4 Weeks Following Induction in Participants With Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 16
- 主要终点
- Number, percentage and severity of treatment emergent adverse events
研究概览
简要总结
This is an open-label, multicenter, Phase 2 study to evaluate the safety and tolerability of mogamulizumab given Q4W following initial weekly induction in adult participants with relapsed/refractory MF and SS subtypes of CTCL. The study is composed of a 28-day Screening Period during which participants are screened for entry into this study, followed by a treatment period of up to 2 years from Cycle 1 Day 1.
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
- •Histologically confirmed diagnosis of MF or SS
- •Stage IB, II-A, II-B, III, or IV;
- •Participants who have failed at least one prior course of systemic therapy (e.g., interferon, bexarotene, photopheresis, anti-neoplastic chemotherapy). Psoralen plus ultraviolet light therapy (PUVA) is not considered a systemic therapy.
排除标准
- •Current evidence of large cell transformation;
- •Prior treatment with mogamulizumab;
- •History of allogeneic transplant.
研究组 & 干预措施
Mogamulizumab
Experimental
干预措施: Mogamulizumab (Drug)
结局指标
主要结局
Number, percentage and severity of treatment emergent adverse events
时间窗: From date of consent, at every treatment and follow up visit, up to 27 months
Adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (v. 5.0).
次要结局
未报告次要终点
研究者
研究点 (16)
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