In a Phase II clinical trial, the combination of Treanda® (bendamustine)®and Rituxan® (rituximab)®produced promising results among patients with relapsed chronic lymphocytic leukemia (CLL). These results were presented at the 50th Annual Meeting of the American Society of Hematology.
CLL is a disease characterized by high numbers of circulating abnormal lymphocytes (B-cells) in the peripheral blood. The disease often involves enlargement of lymph nodes in various parts of the body as well as enlargement of the spleen. It typically occurs in individuals between 65 and 70 years of age.
CLL is the most common adult leukemia, with over 15,000 new cases per year in the United States and more than 4,000 deaths. CLL is not a rapidly growing cancer, but the abnormal cells accumulate in the blood, bone marrow, lymph nodes, and spleen, resulting in enlargement of these organs and decreased bone marrow and immune function. This disease interferes with the normal production of antibodies and immunoglobulins, so the body cannot properly fight infections.
Treanda is a chemotherapy agent that has been approved for the treatment of CLL and certain types of non-Hodgkin®s lymphoma.
Rituxan is a targeted therapy that binds to a marker known as CD20 on the surface of B-cells. This binding prompts the immune system to destroy the cell, and may also have direct anticancer effects on the cell. Rituxan is commonly used in the treatment of non-Hodgkin®s lymphoma, and studies suggest that it®s also active against CLL.
To evaluate the combination of Treanda and Rituxan in the treatment of CLL, researchers in Germany conducted a Phase II clinical trial among 81 patients with relapsed or refractory CLL (CLL that had returned after prior treatment, or that was resistant to prior treatment). All patients were treated with both drugs.
- 77% of patients experienced a complete or partial disappearance of detectable cancer following treatment:
- 63% of patients had a partial response.
- 14% of patients had a complete response.
- Severe side effects included low blood counts and infection.
These results suggest that the combination of Treanda and Rituxan is active against relapsed or refractory CLL. These results have led to a new trial comparing the efficacy of Treanda and Rituxan to Fludara® (fludarabine), Cytoxan® (cyclophosphamide) and Rituxan for treatment of newly diagnosed patients.
Reference: Fischer K, Stilgenbauer S, Schweighofer CD et al. Bendamustine in combination with rituximab (BR) for patients with relapsed chronic lymphocytic leukemia (CLL): a multicentre phase II trial of the German CLL Study Group (GCLLSG). Presented at the 50th Annual Meeting of the American Society of Hematology, San Francisco, CA, December 6-9, 2008. Abstract 330.
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