According to the results of a Phase II clinical trial, the combination of Treanda® (bendamustine) and Rituxan® (rituximab) is effective and safe for the initial treatment of patients with advanced chronic lymphocytic leukemia (CLL). These results were presented at the 2009 annual meeting of the American Society of Hematology.
Chronic lymphocytic leukemia is the most common adult leukemia with over 15,000 new cases per year in the United States and almost 5,000 deaths. CLL is not a rapidly growing cancer, but the abnormal cells accumulate in blood, bone marrow, lymph nodes, and spleen, resulting in enlargement of these organs and decreased bone marrow and immune function.
Treanda is a chemotherapy agent that combines the action of two types of agents, which attack cancerous cells through distinct pathways. In addition to being approved for CLL and relapsed non-Hodgkin’s lymphoma, Treanda is also being evaluated in clinical trials for the treatment of other types of cancer.
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.
The combination of Treanda and Rituxan has produced promising results among patients with previously treated CLL. To evaluate the combination of Treanda and Rituxan in the initial treatment of patients with advanced CLL, researchers in Germany conducted a Phase II clinical trial among 144 patients.
- Overall response rate was 91%, with 33% of patients experiencing a complete remission.
- 2.6% of patients died as a result of treatment.
- At 18 months, 76% of patients were still in remission.
These results suggest that the combination of Treanda and Rituxan may be safe and effective for the initial treatment of advanced CLL. This combination is being further evaluated in Phase III clinical trials.
Fischer K, Cramer P, Stilgenbauer S, et al. Bendamustine combined with rituximab (BR) in first-line therapy of advanced CLL: A multicenter phase II trial of the German CLL Study Group (GCLLSG). Blood 2009;114:89, abstract number 205.