Selenious Yeast in CLL Patients w/o Indication of Chemotherapy

NCT05136378 | Unknown

• 2 other identifiers: 2020ZSLC56B2021-447R
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• 2-year DPR

  2-year Disease Progression Rate

  2 years from enrollment

• Decrease rate of Lymphocyte

  Decrease rate of peripheral lymphocyte counts

  2 years from enrollment

Secondary Outcomes (4)

• Selenium Concentration, Serum

  Enrollment, 1 Month(from enrollment), 3 Months, 6 Months

• adverse events

  Enrollment, 1 Month (from enrollment), 3 Months, 6 Months

• progression free survival (PFS)

  2 years from enrollment

• overall survival (OS)

  2 years from enrollment

Study Arms (3)

Control Arm

NO INTERVENTION

Wait and Watch.

Low Dose Selenious Yeast

EXPERIMENTAL

Receive 200μg Selenious Yeast per day.

Drug: Low Dose Selenious Yeast Tablets

High Dose Selenious Yeast

EXPERIMENTAL

Receive 400μg Selenious Yeast per day.

Drug: High Dose Selenious Yeast Tablets

Interventions

Low Dose Selenious Yeast Tablets DRUG

Low dose of Selenious Yeast Tablets

Low Dose Selenious Yeast

High Dose Selenious Yeast Tablets DRUG

High Dose Selenious Yeast Tablets

High Dose Selenious Yeast

Eligibility Criteria

• Age: 17 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Shanghai Changzheng Hospital: collaborator

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: November 29, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

CN (1)