Selenious Yeast in CLL Patients w/o Indication of Chemotherapy

Chronic Lymphocytic Leukemia Stage A(0) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05136378
• Other study ID #: 2020ZSLC56
• Secondary ID: B2021-447R
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2021
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia Stage A(0)
• Chronic Lymphocytic Leukemia Stage A(I)
• Chronic Lymphocytic Leukemia Stage A(II)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Low Dose Selenious Yeast Tablets
Low dose of Selenious Yeast Tablets
• High Dose Selenious Yeast Tablets
High Dose Selenious Yeast Tablets

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year DPR	2-year Disease Progression Rate	2 years from enrollment
Primary	Decrease rate of Lymphocyte	Decrease rate of peripheral lymphocyte counts	2 years from enrollment
Secondary	Selenium Concentration, Serum	Serum selenium concentration	Enrollment, 1 Month(from enrollment), 3 Months, 6 Months
Secondary	adverse events	safety profile of the subjects from enrollment	Enrollment, 1 Month (from enrollment), 3 Months, 6 Months
Secondary	progression free survival (PFS)		2 years from enrollment
Secondary	overall survival (OS)		2 years from enrollment