Using Selenious Yeast to Help CLL Patients Without Chemotherapy Needs
Administration of Selenious Yeast Tablets in Chronic Lymphocytic Leukemia Patients Without Indication of Chemotherapy: A Multicenter Study
NA · Shanghai Zhongshan Hospital · NCT05136378
This study is testing if Selenious Yeast Tablets can help people with Chronic Lymphocytic Leukemia who don't need chemotherapy and have low selenium levels, to see if it can slow down their disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 17 Years to 99 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05136378 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of Selenious Yeast Tablets in patients diagnosed with Chronic Lymphocytic Leukemia (CLL) who do not require chemotherapy. It focuses on patients with low serum selenium levels, which have been correlated with the clinical stage of CLL. The study aims to prevent disease progression in these patients by administering either low or high doses of Selenious Yeast. The research is based on previous findings that sodium selenite can inhibit certain pathways in CLL cells, potentially improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed CLL patients who meet specific clinical criteria and have not yet started chemotherapy.
Not a fit: Patients with advanced CLL requiring immediate chemotherapy or those with other types of lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help prevent disease progression in CLL patients who are not candidates for chemotherapy.
How similar studies have performed: While there is some preliminary evidence supporting the role of selenium in CLL, this specific approach using Selenious Yeast is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai
- Zhongshan Hospital — Shanghai, Shanghai, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Lymphocytic Leukemia Stage A, Chronic Lymphocytic Leukaemia Stage B, Chronic Lymphocytic Leukemia, Humans, Prospective Studies, Selenium