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| ID | Type | Description | Link |
|---|---|---|---|
| B2021-447R | Other Identifier | EC, Zhongshan Hospital |
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| Name | Class |
|---|---|
| Shanghai Changzheng Hospital | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | Wait and Watch. | |
| Low Dose Selenious Yeast | Experimental | Receive 200μg Selenious Yeast per day. |
|
| High Dose Selenious Yeast | Experimental | Receive 400μg Selenious Yeast per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Selenious Yeast Tablets | Drug | Low dose of Selenious Yeast Tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Selenium Concentration, Serum | Serum selenium concentration | Enrollment, 1 Month(from enrollment), 3 Months, 6 Months |
| adverse events | safety profile of the subjects from enrollment |
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Inclusion Criteria:
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Newly diagnosed CLL/small lymphocytic lymphoma (SLL) that meets criteria below:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| High Dose Selenious Yeast Tablets |
| Drug |
High Dose Selenious Yeast Tablets |
|
| Enrollment, 1 Month (from enrollment), 3 Months, 6 Months |
| progression free survival (PFS) | 2 years from enrollment |
| overall survival (OS) | 2 years from enrollment |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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