Pretreatment With Valproate Prior to Immunotherapy Targeting Cluster of Differentiation Antigen 20 in Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Levels of CD20 protein and messengerRNA in response to treatment with valproate in patients with chronic lymphatic leukemia.
研究概览
简要总结
This trial includes patients with chronic lymphocytic leukemia, the most common kind of malignant lymphoma. Monoclonal antibodies directed against cluster of differentiation antigen 20 have improved treatment results in different forms of lymphomas; however in chronic lymphocytic leukemia treatment with monoclonal antibodies is less effective, and it has been suggested that this is depending on a lower expression of the cluster of differentiation antigen 20 protein on the chronic lymphocytic leukemia cells.
Valproate, an anticonvulsant drug, has been shown to increase the cluster of differentiation antigen 20 expression, and the rationale in this study is that an increasement of cluster of differentiation antigen 20 would make treatment with monoclonal antibodies in patients with chronic lymphocytic leukemia more effective.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Histologically confirmed chronic lymphocytic leukemia
- •Leucocyte count more than 20 x 10 9/L
- •No other simultaneous treatment for lymphoma
- •No treatment indicated for chronic lymphocytic leukemia
- •WHO performance status 0-2
- •HIV negativity
- •Negativity for hepatitis C virus , HBsAG, anti-hepatitis B core antigen, or other active infection uncontrolled by treatment
- •Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy
- •Agree not to share study medication with another person and to return all unused study drug to the investigator
- •Written informed concent
排除标准
- •Psychiatric illness or condition which could interfere with the subjects' ability to understand the requirements of the study
- •Neurological or neuropsychiatric disorder, interfering with the requirements of the study
- •Hearing impairment over grade 2
- •Porphyria
- •History of acute or chronic hepatitis
- •Family history of severe drug-induced hepatitis
- •Pregnancy and lactation
研究组 & 干预措施
Valproate
干预措施: Valproate (Drug)
结局指标
主要结局
Levels of CD20 protein and messengerRNA in response to treatment with valproate in patients with chronic lymphatic leukemia.
时间窗: Blood samples to determine the level of CD20 and messengerRNA are taken day 1 and 4 at each cycle; 3 cycles are given with a cycle length of 21 days. Valproate concentration are taken day 1, 2, 3 and 4 at each cycle.
次要结局
- Translational blood samples.(Blood tests for translational studies of the epigenetic and transcriptional regulation of the CD20 promotor are taken prestudy, day 1, 2, 3 and 4 at each cycle and 3 months post treatment.)