Clinical trial NCT05136378: 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
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Changzheng Hospital
First posted: 2021-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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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.

Primary outcomes:
measure: 2-year DPR
timeFrame: 2 years from enrollment
measure: Decrease rate of Lymphocyte
timeFrame: 2 years from enrollment
Secondary outcomes:
measure: Selenium Concentration, Serum
timeFrame: Enrollment, 1 Month(from enrollment), 3 Months, 6 Months
measure: adverse events
timeFrame: Enrollment, 1 Month (from enrollment), 3 Months, 6 Months
measure: progression free survival (PFS)
timeFrame: 2 years from enrollment
measure: overall survival (OS)
timeFrame: 2 years from enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
References: