Administration of Selenious Yeast Tablets in Chronic Lymphocytic Leukemia Patients Without Indication of Chemotherapy: A Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 2-year DPR
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of Selenious Yeast Tablets in Chronic Lymphocytic Leukemia Patients without Indication of Chemotherapy
详细描述
A large portion of CLL patients has no indications of chemotherapy when diagnosed. In patients with CLL, the mean serum selenium levels are lower than normal. There is a correlation between the selenium level and the clinical stage. We discovered that sodium selenite inhibited the expression of CXCL-1 and restored the defective necroptotic pathway of CLL cells together with TNF-α and z-VAD in vitro. The purpose of this study is to evaluate the safety and effectiveness of Selenious Yeast Tablets in preventing CLL patients without indication of chemotherapy from disease development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed CLL/small lymphocytic lymphoma (SLL) that meets criteria below:
- •Newly diagnosed (< 12 months from pre-registration on this study) CLL according to the National Cancer Institute (NCI) criteria or SLL according to the World Health Organization (WHO) criteria; this includes previous documentation of: Biopsy-proven small lymphocytic lymphoma OR Diagnosis of CLL according to NCI working group criteria as evidenced by all of the following: Peripheral blood lymphocyte count of > 5,000/mm^3; if present, prolymphocytes should be < 55% AND Immunophenotyping consistent with CLL defined as:The predominant population of lymphocytes share both B-cell antigens (cluster of differentiation [CD]19, CD20, or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc.) Dim surface immunoglobulin expression Restricted surface kappa or lambda light chain expression Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative fluorescent in situ hybridization (FISH) analysis for t(11;14)(immunoglobulin H [IgH]/cyclin D 1 [CCND1]) on peripheral blood or tissue biopsy or negative immunohistochemical stains for cyclin D1 on involved tissue biopsy
- •Rai stage 0 or 1
- •Previously untreated
- •Asymptomatic with the plan for observation(NOT meet iwCLL indication of chemotherapy)
- •Life expectancy of at least 12 months
- •Willing to provide tissue for correlative research purpose
排除标准
- •Concentration of serum Se exceed the normal range
- •Active other malignancy requiring treatment that would interfere with the assessments of this study
- •Hepatitis B or C
- •Autoimmune disease history
- •Organ transplant recipients need to receive drug therapy
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Low Dose Selenious Yeast
Receive 200μg Selenious Yeast per day.
干预措施: Low Dose Selenious Yeast Tablets (Drug)
High Dose Selenious Yeast
Receive 400μg Selenious Yeast per day.
干预措施: High Dose Selenious Yeast Tablets (Drug)
结局指标
主要结局
2-year DPR
时间窗: 2 years from enrollment
2-year Disease Progression Rate
Decrease rate of Lymphocyte
时间窗: 2 years from enrollment
Decrease rate of peripheral lymphocyte counts
次要结局
- Selenium Concentration, Serum(Enrollment, 1 Month(from enrollment), 3 Months, 6 Months)
- adverse events(Enrollment, 1 Month (from enrollment), 3 Months, 6 Months)
- progression free survival (PFS)(2 years from enrollment)
- overall survival (OS)(2 years from enrollment)