Selenious Yeast in CLL Patients w/o Indication of Chemotherapy

November 26, 2021 updated by: Shanghai Zhongshan Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zheng Wei, M.D.
        • Sub-Investigator:
          • Yi-an Zhang, M.D.
        • Sub-Investigator:
          • Shi-yang Gu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year DPR
Time Frame: 2 years from enrollment
2-year Disease Progression Rate
2 years from enrollment
Decrease rate of Lymphocyte
Time Frame: 2 years from enrollment
Decrease rate of peripheral lymphocyte counts
2 years from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Selenium Concentration, Serum
Time Frame: Enrollment, 1 Month(from enrollment), 3 Months, 6 Months
Serum selenium concentration
Enrollment, 1 Month(from enrollment), 3 Months, 6 Months
adverse events
Time Frame: Enrollment, 1 Month (from enrollment), 3 Months, 6 Months
safety profile of the subjects from enrollment
Enrollment, 1 Month (from enrollment), 3 Months, 6 Months
progression free survival (PFS)
Time Frame: 2 years from enrollment
2 years from enrollment
overall survival (OS)
Time Frame: 2 years from enrollment
2 years from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Shanghai Changzheng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

November 26, 2021

First Posted (Actual)

November 29, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2021

Last Update Submitted That Met QC Criteria

November 26, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020ZSLC56
  • B2021-447R (Other Identifier: EC, Zhongshan Hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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