Selenious Yeast in CLL Patients w/o Indication of Chemotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Administration of Selenious Yeast Tablets in Chronic Lymphocytic Leukemia Patients Without Indication of Chemotherapy: A Multicenter Study

Conditions
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Chronic Lymphocytic Leukemia Stage A(0), Chronic Lymphocytic Leukemia Stage A(I), Chronic Lymphocytic Leukemia Stage A(II), Chronic Lymphocytic Leukaemia Stage B(I)

Intervention / Treatment
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* Drug: Low Dose Selenious Yeast Tablets
* Drug: High Dose Selenious Yeast Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Wait and Watch. | |
| Experimental: Low Dose Selenious Yeast<br>Receive 200μg Selenious Yeast per day. | Drug: Low Dose Selenious Yeast Tablets<br>* Low dose of Selenious Yeast Tablets<br>|
| Experimental: High Dose Selenious Yeast<br>Receive 400μg Selenious Yeast per day. | Drug: High Dose Selenious Yeast Tablets<br>* High Dose Selenious Yeast Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year DPR | 2-year Disease Progression Rate | 2 years from enrollment | 
| Decrease rate of Lymphocyte | Decrease rate of peripheral lymphocyte counts | 2 years from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Selenium Concentration, Serum | Serum selenium concentration | Enrollment, 1 Month(from enrollment), 3 Months, 6 Months | 
| adverse events | safety profile of the subjects from enrollment | Enrollment, 1 Month (from enrollment), 3 Months, 6 Months | 
| progression free survival (PFS) |  | 2 years from enrollment | 
| overall survival (OS) |  | 2 years from enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Lymphocytic Leukemia, Humans, Prospective Studies, Selenium