Chronic Lymphocytic Leukaemia Stage B(I), Chronic Lymphocytic Leukemia Stage A(0), Chronic Lymphocytic Leukemia Stage A(I), Chronic Lymphocytic Leukemia Stage A(II)
Conditions
Keywords
Chronic Lymphocytic Leukemia, Humans, Prospective Studies, Selenium
Brief summary
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
Detailed description
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.
Interventions
DRUGLow Dose Selenious Yeast Tablets
Low dose of Selenious Yeast Tablets
DRUGHigh Dose Selenious Yeast Tablets
High Dose Selenious Yeast Tablets
Sponsors
Shanghai Changzheng Hospital
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
\- Newly diagnosed CLL/small lymphocytic lymphoma (SLL) that meets criteria below: 1. 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 2. Rai stage 0 or 1 3. Previously untreated 4. Asymptomatic with the plan for observation(NOT meet iwCLL indication of chemotherapy) 5. Life expectancy of at least 12 months 6. Willing to provide tissue for correlative research purpose
Exclusion criteria
1. Concentration of serum Se exceed the normal range 2. Active other malignancy requiring treatment that would interfere with the assessments of this study 3. Hepatitis B or C 4. Autoimmune disease history 5. Organ transplant recipients need to receive drug therapy 6. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year DPR | 2 years from enrollment | 2-year Disease Progression Rate |
| Decrease rate of Lymphocyte | 2 years from enrollment | Decrease rate of peripheral lymphocyte counts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Selenium Concentration, Serum | Enrollment, 1 Month(from enrollment), 3 Months, 6 Months | Serum selenium concentration |
| adverse events | Enrollment, 1 Month (from enrollment), 3 Months, 6 Months | safety profile of the subjects from enrollment |
| progression free survival (PFS) | 2 years from enrollment | — |
| overall survival (OS) | 2 years from enrollment | — |
Countries
China
Outcome results
None listed