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Selenious Yeast in CLL Patients w/o Indication of Chemotherapy

NCT ID: NCT05136378

Last Updated: 2021-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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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

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Chronic Lymphocytic Leukemia Humans Prospective Studies Selenium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Arm

Wait and Watch.

Group Type NO_INTERVENTION

No interventions assigned to this group

Low Dose Selenious Yeast

Receive 200μg Selenious Yeast per day.

Group Type EXPERIMENTAL

Low Dose Selenious Yeast Tablets

Intervention Type DRUG

Low dose of Selenious Yeast Tablets

High Dose Selenious Yeast

Receive 400μg Selenious Yeast per day.

Group Type EXPERIMENTAL

High Dose Selenious Yeast Tablets

Intervention Type DRUG

High Dose Selenious Yeast Tablets

Interventions

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Low Dose Selenious Yeast Tablets

Low dose of Selenious Yeast Tablets

Intervention Type DRUG

High Dose Selenious Yeast Tablets

High Dose Selenious Yeast Tablets

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Changzheng Hospital

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Zheng Wei, M.D.

Role: primary

Yi-an Zhang, M.D.

Role: backup

Other Identifiers

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B2021-447R

Identifier Type: OTHER

Identifier Source: secondary_id

2020ZSLC56

Identifier Type: -

Identifier Source: org_study_id