Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290407
Status:
TERMINATED
Last Update Posted:
2018-05-04
First Post:
2006-02-09
Brief Title:
Rituximab Plus Beta-Glucan in Chronic Lymphocytic LeukemiaCLLSmall Lymphocytic Lymphoma SLL
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Phase II Study of Rituximab Plus B-Glucan in Patients With Chronic Lymphocytic LeukemiaCLLSmall Lymphocytic Lymphoma SLL
Status:
TERMINATED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
terminated due to lack of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine how well subjects respond to treatment with Rituximab plus Beta-Glucan
Detailed Description:
Chronic lymphocytic leukemia CLL is the most common form of leukemia in adults CLL is a cancer of the B-lymphocytes which make antibodies that help protect the body against harmful foreign substances such as bacteria and viruses Similar to CLL small lymphocytic lymphoma SLL is a less-common cancer of the B-lymphocytes In SLL the abnormal lymphocytes mainly affect the lymph nodes in CLL the abnormal lymphocytes mainly affect the blood and bone marrow
Current drug therapies for CLLSLL are known to increase the severity of pre-existing low blood cell counts which in turn increase the risk of infections in patients Research to improve the safety and effectiveness of CLLSLL therapy is currently ongoing One such therapy being investigated is Rituximab
Rituximab is a type of drug known as a therapeutic antibody Therapeutic antibodies are laboratory-created substances that attach onto a protein on the surface of a cell After binding to the cell the therapeutic antibody can block the growth of the tumor andor trigger the bodys immune system to attack the target and can also sensitize a cancer cell to chemotherapy Rituximab is approved by the Food and Drug Administration FDA for the treatment of CLLSLL
Beta-Glucan Imucell WGP is an over-the-counter dietary supplement that enhances the bodys immune system ImucellTM WGP is extracted from food-grade bakers yeast which is permitted for use in food by the FDA Animal studies have shown that Imucell WGP helps trigger the white blood cells to destroy cancer cells Other animal studies combining Rituximab with Imucell WGP have shown greater tumor regression and tumor-free survival
Current drug therapies for CLLSLL are known to increase the severity of pre-existing low blood cell counts which in turn increase the risk of infections in patients Research to improve the safety and effectiveness of CLLSLL therapy is currently ongoing One such therapy being investigated is Rituximab
Rituximab is a type of drug known as a therapeutic antibody Therapeutic antibodies are laboratory-created substances that attach onto a protein on the surface of a cell After binding to the cell the therapeutic antibody can block the growth of the tumor andor trigger the bodys immune system to attack the target and can also sensitize a cancer cell to chemotherapy Rituximab is approved by the Food and Drug Administration FDA for the treatment of CLLSLL
Beta-Glucan Imucell WGP is an over-the-counter dietary supplement that enhances the bodys immune system ImucellTM WGP is extracted from food-grade bakers yeast which is permitted for use in food by the FDA Animal studies have shown that Imucell WGP helps trigger the white blood cells to destroy cancer cells Other animal studies combining Rituximab with Imucell WGP have shown greater tumor regression and tumor-free survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BCC-HEM-06-001 | OTHER | James Graham Brown Cancer Center Clinical Trials Office | None |