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Sponsors and Collaborators: |
James Graham Brown Cancer Center University of Louisville |
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Information provided by: | James Graham Brown Cancer Center |
ClinicalTrials.gov Identifier: | NCT00290407 |
The purpose of this study is to determine how well subjects respond to treatment with Rituximab plus Beta-Glucan.
Condition | Intervention | Phase |
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Leukemia, Lymphocytic, Chronic Lymphoma, Small Lymphocytic |
Drug: Rituximab Dietary Supplement: Beta-Glucan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Rituximab Plus B-Glucan in Patients With Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL) |
Estimated Enrollment: | 20 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
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 CLL/SLL 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 CLL/SLL 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 and/or trigger the body's 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 CLL/SLL. Beta-Glucan (Imucell WGP) is an over-the-counter dietary supplement that enhances the body's immune system. ImucellTM WGP is extracted from food-grade baker's 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stephanie B Copeland, BSN | (502) 562-3429 | sbcope01@louisville.edu |
Contact: Kate K Rodger, MSHCM, BSN | (502) 562-3429 | kkrodg01@louisville.edu |
United States, Kentucky | |
James Graham Brown Cancer Center | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Stephanie B Copeland, BSN 502-562-3429 sbcope01@louisville.edu | |
Principal Investigator: Roger H Herzig, MD | |
Sub-Investigator: Geoffrey P Herzig, MD | |
Sub-Investigator: Jun Yan, PhD |
Principal Investigator: | Roger H Herzig, MD | James Graham Brown Cancer Center/University of Louisville |
Responsible Party: | James Graham Brown Cancer Center ( Roger H. Herzig, MD ) |
Study ID Numbers: | 008.06, BCC-HEM-06-001 |
Study First Received: | February 9, 2006 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00290407 History of Changes |
Health Authority: | United States: Food and Drug Administration |
chronic lymphocytic leukemia small lymphocytic lymphoma rituximab beta-glucan |
Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Rituximab Leukemia Lymphatic Diseases Chronic Lymphocytic Leukemia |
Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic Antirheumatic Agents Lymphoma |
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Pharmacologic Actions |
Leukemia Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Antirheumatic Agents Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma |