Chronic Lymphocytic Leukemia Stage A(0)NCT05136378
Selenious Yeast in CLL Patients w/o Indication of Chemotherapy
A study testing Low Dose Selenious Yeast Tablets and High Dose Selenious Yeast Tablets in people with Chronic Lymphocytic Leukemia Stage A(0) and Chronic Lymphocytic Leukemia Stage A(I), run by Shanghai Zhongshan Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 17 to 99 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia Stage A(0), Chronic Lymphocytic Leukemia Stage A(I), Chronic Lymphocytic Leukemia Stage A(II)
- What is being tested?
- Low Dose Selenious Yeast Tablets and High Dose Selenious Yeast Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Zheng Wei, M.D., 021-64041990 ext. 692225, wei.zheng@zs-hospital.sh.cn
Yi-an Zhang, M.D., 021-64041990 ext. 692325, zhang.yi_an@zs-hospital.sh.cn
About this study
Official title: 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
Read the 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.
- 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)
- Being tested
- Low Dose Selenious Yeast Tablets, High Dose Selenious Yeast Tablets
- Keywords
- Chronic Lymphocytic Leukemia, Humans, Prospective Studies, Selenium
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose Selenious Yeast TabletsDrug
Low dose of Selenious Yeast Tablets
High Dose Selenious Yeast TabletsDrug
High Dose Selenious Yeast Tablets
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Wait and Watch. |
| Low Dose Selenious Yeast | Experimental | Receive 200μg Selenious Yeast per day. Receives: Drug: Low Dose Selenious Yeast Tablets |
| High Dose Selenious Yeast | Experimental | Receive 400μg Selenious Yeast per day. Receives: Drug: High Dose Selenious Yeast Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year DPR
2-year Disease Progression Rate
Measured: 2 years from enrollment
Decrease rate of Lymphocyte
Decrease rate of peripheral lymphocyte counts
Measured: 2 years from enrollment
Secondary outcomes (4)
Selenium Concentration, Serum
Serum selenium concentration
Measured: Enrollment, 1 Month(from enrollment), 3 Months, 6 Months
adverse events
safety profile of the subjects from enrollment
Measured: Enrollment, 1 Month (from enrollment), 3 Months, 6 Months
progression free survival (PFS)
Measured: 2 years from enrollment
overall survival (OS)
Measured: 2 years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia Stage A(0)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Changzheng Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136378
- Sponsor's protocol ID
- 2020ZSLC56
- Other IDs
- B2021-447R
- Status last verified
- Nov 2021
- First submitted
- 23 Nov 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Selenious Yeast Tablets in Chronic Lymphocytic Leukemia Patients Without Indication of Chemotherapy: A Multicenter Study
- ClinicalTrials.gov ID
- NCT05136378
- Acronym / sponsor ID
- 2020ZSLC56
- 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)
- Keywords
- Chronic Lymphocytic Leukemia, Humans, Prospective Studies, Selenium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Changzheng Hospital
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Wait and Watch. |
| Low Dose Selenious Yeast | Experimental | Drug: Low Dose Selenious Yeast TabletsReceive 200μg Selenious Yeast per day. |
| High Dose Selenious Yeast | Experimental | Drug: High Dose Selenious Yeast TabletsReceive 400μg Selenious Yeast per day. |
Who may qualify
- Ages
- 17 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- -
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose Selenious Yeast TabletsLow dose of Selenious Yeast Tablets | Drug | Low Dose Selenious Yeast |
| High Dose Selenious Yeast TabletsHigh Dose Selenious Yeast Tablets | Drug | High Dose Selenious Yeast |
Primary outcome
2-year DPR
Time frame: 2 years from enrollment
2-year Disease Progression Rate
Decrease rate of Lymphocyte
Time frame: 2 years from enrollment
Decrease rate of peripheral lymphocyte counts
4 secondary outcomes
Selenium Concentration, Serum
Time frame: Enrollment, 1 Month(from enrollment), 3 Months, 6 Months
adverse events
Time frame: Enrollment, 1 Month (from enrollment), 3 Months, 6 Months
progression free survival (PFS)
Time frame: 2 years from enrollment
overall survival (OS)
Time frame: 2 years from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dose Selenious Yeast Tablets and High Dose Selenious Yeast Tablets in people with Chronic Lymphocytic Leukemia Stage A(0) and Chronic Lymphocytic Leukemia Stage A(I), run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year DPR (time frame: 2 years from enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.