Selenious Yeast in CLL Patients w/o Indication of Chemotherapy

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Collaborator: Shanghai Changzheng Hospital

Criteria

Inclusion Criteria:

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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.