B-lymphocyte Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Severely Affected Chronic Fatigue Syndrome Patients. An Open Label Phase II Study With Rituximab Induction and Maintenance Treatment for Patients in WHO Performance Status III-IV
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes
研究概览
简要总结
Based on pilot patient observations, and experience from the prior study KTS-1-2008, the investigators anticipate that severely affected chronic fatigue syndrome patients may benefit from B-cell depletion therapy using Rituximab induction with maintenance treatment.
The hypothesis is that at least a subset of chronic fatigue syndrome (CFS) patients have an activated immune system involving B-lymphocytes, and that prolonged B-cell depletion may alleviate symptoms.
An approved amendment (April 15th 2011): the study will be extended with up to 5 patients. For up to 5 patients in the study, standard plasma exchange may be performed 2-3 weeks prior to start of B-lymphocyte depletion using Rituximab (as in the protocol).
Approved amendment (December 2011): for patients with gradual improvement in CFS/ME symptoms after 12 months follow-up, but not having reached a clear response, up to 6 additional Rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months period.
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 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients severely affected by chronic fatigue syndrome, in WHO performance status III or IV.
- •age 18-66 years
- •informed consent
排除标准
- •patients with fatigue, not fulfilling criteria for CFS
- •pregnancy or lactation
- •previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
- •previous major immunological disease, except autoimmune diseases such as diabetes mellitus or thyroiditis
- •endogenous depression
- •lack of ability to comply by the protocol
- •multi-allergy with risk of serious drug reaction
- •reduced renal function (creatinin > 1.5 x upper normal limit [UNL])
- •reduced liver function (bilirubin or transaminases > 1.5 x UNL)
- •HIV positivity
- •evidence of clinically significant infection
研究组 & 干预措施
Rituximab
Rituximab induction two infusions (500 mg/m2, max 1000 mg) two weeks apart, followed by maintenance Rituximab infusions (500 mg/m2, max 1000 mg) after 3, 6, 10 and 15 months.
干预措施: Rituximab (Drug)
结局指标
主要结局
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes
时间窗: Major response of at least six weeks duration, independent on when occuring, during the follow-up period
The primary endpoint is defined as major response of the CFS symptoms, of at least six weeks duration, independent on when during 36 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.
次要结局
- Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.(At 3, 6, 10, 15, 20, 24, 30, 36 months after intervention)