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.
The chemotherapy agent Treanda® (bendamustine) was been added to the treatment guidelines of the National Comprehensive Cancer Network (NCCN) as an accepted treatment option for chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL).
The NCCN is an alliance of 21 leading cancer centers. The NCCN has developed treatment guidelines for most types of cancer, including NHL and leukemia, and updates their guidelines annually. This year, the chemotherapy agent Treanda was added to updated guidelines including follicular NHL, mantle-cell NHL, and CLL. Treanda was recently approved by the U.S. Food and Drug Administration for the treatment of CLL among patients who had stopped responding to the chemotherapy agent chlorambucil (Leukeran®).2
The 2008 NCCN treatment guideline updates that include Treanda are the following:
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- Treanda as a single agent as initial therapy for CLL
- Treanda as a single agent or in combination with Rituxan® (rituximab) for treatment of CLL that has recurred following prior therapy (second-line therapy)
- Treanda with or without Rituxan as second-line therapy for follicular lymphoma or mantle-cell lymphoma
Treanda + Rituxan
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.1
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.
- The National Comprehensive Cancer Network. NCCN Updates Non-Hodgkin’s Lymphoma Guidelines. Available at: . Accessed May 2008.