Rituximab Plus Beta-Glucan in Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL)
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|ClinicalTrials.gov Identifier: NCT00290407|
Recruitment Status : Terminated (terminated due to lack of accrual)
First Posted : February 13, 2006
Results First Posted : June 24, 2013
Last Update Posted : May 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Lymphocytic, Chronic Lymphoma, Small Lymphocytic||Drug: Rituximab Dietary Supplement: Beta-Glucan||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Rituximab Plus B-Glucan in Patients With Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL)|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
- Drug: Rituximab
375 mg/m2, IV (in the vein), once a week for 4 weeksOther Name: Rituxan
- Dietary Supplement: Beta-Glucan
250 mg, orally (tablet), three times a day for 9 weeksOther Name: Imucell WGP
- CT Scan to Measure Clinical Effect (Response) [ Time Frame: 3 months after starting treatment, 6 months after starting treatment, and every 6 months (after completing treatment) until disease progression ]Study terminated, results data not available
- Blood Specimens Will be Collected to Measure Immunologic Effect [ Time Frame: at weeks 4, 8, 12, and at month 6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290407
|United States, Kentucky|
|James Graham Brown Cancer Center|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Roger H Herzig, MD||James Graham Brown Cancer Center/University of Louisville|