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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Low dose of Selenious Yeast Tablets
High Dose Selenious Yeast Tablets
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITING2-year DPR
2-year Disease Progression Rate
Time frame: 2 years from enrollment
Decrease rate of Lymphocyte
Decrease rate of peripheral lymphocyte counts
Time frame: 2 years from enrollment
Selenium Concentration, Serum
Serum selenium concentration
Time frame: Enrollment, 1 Month(from enrollment), 3 Months, 6 Months
adverse events
safety profile of the subjects from enrollment
Time frame: Enrollment, 1 Month (from enrollment), 3 Months, 6 Months
progression free survival (PFS)
Time frame: 2 years from enrollment
overall survival (OS)
Time frame: 2 years from enrollment
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