Selenious Yeast in CLL Patients w/o Indication of Chemotherapy

Not Applicable

Recruiting

• Conditions: Chronic Lymphocytic Leukemia Stage A(0); Chronic Lymphocytic Leukemia Stage A(I); Chronic Lymphocytic Leukemia Stage A(II); Chronic Lymphocytic Leukaemia Stage B(I)
• Interventions: Drug: Low Dose Selenious Yeast Tablets; Drug: High Dose Selenious Yeast Tablets

• Registration Number: NCT05136378
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-01
• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-26
• Last Update Submitted: 2021-11-26
• Study First Posted: 2021-11-29
• Last Update Posted: 2021-11-29
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose Selenious Yeast	Low Dose Selenious Yeast Tablets	Receive 200μg Selenious Yeast per day.
High Dose Selenious Yeast	High Dose Selenious Yeast Tablets	Receive 400μg Selenious Yeast per day.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
overall survival (OS)	2 years from enrollment
progression free survival (PFS)	2 years from enrollment

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China