Phase II Study of Rituximab Plus B-Glucan in Patients With Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL)
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
CT Scan to Measure Clinical Effect (Response)
Study terminated, results data not available
3 months after starting treatment, 6 months after starting treatment, and every 6 months (after completing treatment) until disease progression
Roger H Herzig, MD
James Graham Brown Cancer Center/University of Louisville
United States: Food and Drug Administration
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