Neoplasms

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All Conditions

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Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Micronutrients

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Selenium

Low Dose Selenious Yeast Tablets

High Dose Selenious Yeast Tablets

Zheng Wei, M.D.

Yi-an Zhang, M.D.

Shi-yang Gu, M.D.

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

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.

Selenious Yeast in CLL Patients w/o Indication of Chemotherapy

Administration of Selenious Yeast Tablets in Chronic Lymphocytic Leukemia Patients Without Indication of Chemotherapy: A Multicenter Study

Decrease rate of peripheral lymphocyte counts

safety profile of the subjects from enrollment

Shanghai Changzheng Hospital

Shanghai Zhongshan Hospital

Fortunato Morabito, MD

Emanuela A Pesce, BSc

Massimo Federico, MD

Manlio Ferrarini, MD

The purpose of the present study is to develop a biological prognostic index in patients with Binet stage A Chronic Lymphocytic Leukemia (CLL) who do not necessitate therapy according to NCI guidelines and to prospectively validate the proposed score system based on the absence/presence of 1, 2 or 3 unfavorable prognostic markers such as cluster of differentiation 38 (CD38) expression, Zap-70 expression and immunoglobulin heavy chain variable region (IgVH) configuration.

Clinical data including information on disease localization and laboratory parameters will be collected at study entry, during follow up and at disease progression (or after 36 months after registration) Biological markers will be evaluated at centralized laboratory, at study entry and at time of disease progression (or after 24 months of follow-up for non progressed patients) Using the scoring system, patients can be separated into 3 risk groups: low-risk (score 0), intermediate-risk (score 1) and high-risk (score 2-3), with significantly different clinical courses.

Prospective Collection of Biological Data of Prognostic Relevance in Patients With B-Cell Chronic Lymphocytic Leukemia

Prospective Collection of Biological Data of Prognostic Relevance in Patients

Gruppo Italiano Studio Linfomi

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Selenious Yeast in CLL Patients w/o Indication of Chemotherapy	NCT05136378	Chronic Lymphoc... Chronic Lymphoc... Chronic Lymphoc... Chronic Lymphoc...	Low Dose Seleni... High Dose Selen...	17 Years - 99 Years	Shanghai Zhongshan Hospital
Prospective Collection of Biological Data of Prognostic Relevance in Patients With B-Cell Chronic Lymphocytic Leukemia	NCT00917540	Chronic Lymphoc... Chronic Lymphoc... Chronic Lymphoc...		18 Years - 80 Years	Gruppo Italiano Studio Linfomi
Prospective Collection of Biological Data of Prognostic Relevance in Patients With B-Cell Chronic Lymphocytic Leukemia	NCT00917540	Chronic Lymphoc... Chronic Lymphoc... Chronic Lymphoc...		18 Years - 80 Years	Gruppo Italiano Studio Linfomi

Spots Global Cancer Trial Database for chronic lymphocytic leukemia stage a(ii)