Selenious Yeast in CLL Patients w/o Indication of Chemotherapy

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05136378

Collaborator

Shanghai Changzheng Hospital (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia Stage A(0) Chronic Lymphocytic Leukemia Stage A(I) Chronic Lymphocytic Leukemia Stage A(II) Chronic Lymphocytic Leukaemia Stage B(I)	Drug: Low Dose Selenious Yeast Tablets Drug: High Dose Selenious Yeast Tablets	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Arm Wait and Watch.
Experimental: Low Dose Selenious Yeast Receive 200μg Selenious Yeast per day.	Drug: Low Dose Selenious Yeast Tablets Low dose of Selenious Yeast Tablets
Experimental: High Dose Selenious Yeast Receive 400μg Selenious Yeast per day.	Drug: High Dose Selenious Yeast Tablets High Dose Selenious Yeast Tablets

Arm

Intervention/Treatment

No Intervention: Control Arm

Wait and Watch.

Experimental: Low Dose Selenious Yeast

Receive 200μg Selenious Yeast per day.

Drug: Low Dose Selenious Yeast Tablets

Low dose of Selenious Yeast Tablets

Experimental: High Dose Selenious Yeast

Receive 400μg Selenious Yeast per day.

Drug: High Dose Selenious Yeast Tablets

High Dose Selenious Yeast Tablets

Outcome Measures

Primary Outcome Measures

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

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
progression free survival (PFS) [2 years from enrollment]
overall survival (OS) [2 years from enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.