Phase IIA Study on Therapy With the NF-κB Inhibiting and Apoptosis Inducing Drug Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- safety (via occurrence of AE/SAE) of DMF treatment in CTCL
研究概览
简要总结
The main objective of the trial is to investigate whether oral treatment of patients suffering from cutaneous T cell lymphoma with dimethylfumarate is leading to a significant improvement of modified severity assessment tool (mSWAT) values in the skin after 24 weeks of treatment (primary endpoint). Secondary endpoints are dermatologic life quality index, itching and pain measured by a NRS and the blood involvement if applicable.
Primary: safety and efficacy of DMF treatment in CTCL Secondary: Dermatologic Life Quality index, NRS for itching and pain, blood involvement if appl.
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
treatment arm
patients are treated with dimethylfumarate over 24 weeks. Dosage will be escalated weekly from 30 mg/d to 720 mg/d over 9 weeks. The dose escalation scheme is the same as approved for psoriasis treatment in Germany
干预措施: Dimethyl fumarate (Drug)
结局指标
主要结局
safety (via occurrence of AE/SAE) of DMF treatment in CTCL
时间窗: every 2 weeks until 24 weeks of treatment are finished
Number of patients with Treatment-related Adverse Events as assessed by CTCAE v4.0
efficacy (via improvement of Skin involvement measured by the standardized modified severity weighted assessment tool (mSWAT))of DMF treatment in CTCL
时间窗: every 2 weeks until 24 weeks of treatment are finished
Changes in the mSWAT scores range from 0 \[no patches, Plaques or tumors on the Skin \] to 400 \[complete Body covered by Tumors\]
次要结局
- changes in dermatologic life quality index(every 2 weeks until 24 weeks of treatment are finished)
- changes in pruritus intensity measured by a visual analog scale(every 2 weeks until 24 weeks of treatment are finished)
- changes in blood involvement measured by Sezary cell count (if applicable, only in stage IV patients)(every 2 weeks until 24 weeks of treatment are finished)
研究者
Jan Nicolay
MD MSc
Universitätsmedizin Mannheim