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Selenious Yeast in CLL Patients w/o Indication of Chemotherapy

Primary Purpose

Chronic Lymphocytic Leukemia Stage A(0), Chronic Lymphocytic Leukemia Stage A(I), Chronic Lymphocytic Leukemia Stage A(II)

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low Dose Selenious Yeast Tablets
High Dose Selenious Yeast Tablets
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Lymphocytic Leukemia Stage A(0) focused on measuring Chronic Lymphocytic Leukemia, Humans, Prospective Studies, Selenium

Eligibility Criteria

17 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Arm

Low Dose Selenious Yeast

High Dose Selenious Yeast

Arm Description

Wait and Watch.

Receive 200μg Selenious Yeast per day.

Receive 400μg Selenious Yeast per day.

Outcomes

Primary Outcome Measures

2-year DPR
2-year Disease Progression Rate
Decrease rate of Lymphocyte
Decrease rate of peripheral lymphocyte counts

Secondary Outcome Measures

Selenium Concentration, Serum
Serum selenium concentration
adverse events
safety profile of the subjects from enrollment
progression free survival (PFS)
overall survival (OS)

Full Information

First Posted
November 23, 2021
Last Updated
November 26, 2021
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shanghai Changzheng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05136378
Brief Title
Selenious Yeast in CLL Patients w/o Indication of Chemotherapy
Official Title
Administration of Selenious Yeast Tablets in Chronic Lymphocytic Leukemia Patients Without Indication of Chemotherapy: A Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shanghai Changzheng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia Stage A(0), Chronic Lymphocytic Leukemia Stage A(I), Chronic Lymphocytic Leukemia Stage A(II), Chronic Lymphocytic Leukaemia Stage B(I)
Keywords
Chronic Lymphocytic Leukemia, Humans, Prospective Studies, Selenium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Wait and Watch.
Arm Title
Low Dose Selenious Yeast
Arm Type
Experimental
Arm Description
Receive 200μg Selenious Yeast per day.
Arm Title
High Dose Selenious Yeast
Arm Type
Experimental
Arm Description
Receive 400μg Selenious Yeast per day.
Intervention Type
Drug
Intervention Name(s)
Low Dose Selenious Yeast Tablets
Intervention Description
Low dose of Selenious Yeast Tablets
Intervention Type
Drug
Intervention Name(s)
High Dose Selenious Yeast Tablets
Intervention Description
High Dose Selenious Yeast Tablets
Primary Outcome Measure Information:
Title
2-year DPR
Description
2-year Disease Progression Rate
Time Frame
2 years from enrollment
Title
Decrease rate of Lymphocyte
Description
Decrease rate of peripheral lymphocyte counts
Time Frame
2 years from enrollment
Secondary Outcome Measure Information:
Title
Selenium Concentration, Serum
Description
Serum selenium concentration
Time Frame
Enrollment, 1 Month(from enrollment), 3 Months, 6 Months
Title
adverse events
Description
safety profile of the subjects from enrollment
Time Frame
Enrollment, 1 Month (from enrollment), 3 Months, 6 Months
Title
progression free survival (PFS)
Time Frame
2 years from enrollment
Title
overall survival (OS)
Time Frame
2 years from enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng Wei, M.D.
Phone
021-64041990
Ext
692225
Email
wei.zheng@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Yi-an Zhang, M.D.
Phone
021-64041990
Ext
692325
Email
zhang.yi_an@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Zheng Wei, M.D.
First Name & Middle Initial & Last Name & Degree
Yi-an Zhang, M.D.
First Name & Middle Initial & Last Name & Degree
Shi-yang Gu, M.D.

12. IPD Sharing Statement

Learn more about this trial

Selenious Yeast in CLL Patients w/o Indication of Chemotherapy

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