A clinical trial that will evaluate the effectiveness of the addition to Leukine® (sargramostim) to Rituxan® (rituximab) in patients with follicular lymphoma whose cancer has progressed following prior therapies is now enrolling patients.

Non-Hodgkin’s lymphoma (NHL) is a form of cancer that begins in the cells of the lymph system. The lymph system includes the spleen, thymus, tonsils, bone marrow, lymph nodes, and circulating immune cells. The main cells in the lymph system are lymphocytes, of which there are two types: B- and T-cells. Each cell type has a specific function in helping the body fight infection. The vast majority of NHL cases involve B-cells.

NHL is characterized by the excessive accumulation of atypical (cancerous) lymphocytes. These lymphocytes can crowd the lymph system and suppress the formation and function of other immune and blood cells. NHL is categorized by the type of lymphocyte it involves and by the rate at which the cancer grows. Follicular lymphoma comprises 30% of all NHL diagnoses and is considered a low-grade or indolent lymphoma, which means that it is a slow-growing form of lymphoma.

Rituxan is a targeted therapy that binds to specific components of B-lymphocytes, the most common cancerous cells in NHL. The binding of Rituxan to the B-lymphocytes ultimately causes the destruction of the cancer cells. Rituxan is a commonly used agent in the treatment of various forms of NHL. Researchers continue to evaluate ways to improve anticancer responses to Rituxan.

Leukine is a growth factor, or cytokine, which is an agent that can stimulate the immune system to help fight or prevent infection or disease. It is commonly used among patients with leukemia who are undergoing stem cell transplantation. Leukine is also thought to have properties that improve Rituxan’s cancer-killing effects by stimulating the immune system. Side effects associated with Leukine are generally mild to moderate. Results from previous clinical trials have indicated that Leukine improves the effectiveness of Rituxan without causing side effects associated with chemotherapy.[[1]](http://news.cancerconnect.com/novel-treatment-strategy-evaluating-rituxan-plus-leukine-in-lymphoma-patients-begining-clinical-trials/#_edn1 "_ednref1")

Results from a recent animal study compared the addition of cytokines and Rituxan to either Rituxan alone or cytokines alone in the treatment of NHL. Overall, the combination of a cytokine and Rituxan improved overall survival compared with either Rituxan alone or cytokines alone.[[2]](http://news.cancerconnect.com/novel-treatment-strategy-evaluating-rituxan-plus-leukine-in-lymphoma-patients-begining-clinical-trials/#_edn2 "_ednref2") Furthermore, laboratory data has indicated that cytokines in addition to targeted therapy improve the ability of immune cells to kill cancer cells when compared to treatment with cytokines alone.[[3]](http://news.cancerconnect.com/novel-treatment-strategy-evaluating-rituxan-plus-leukine-in-lymphoma-patients-begining-clinical-trials/#_edn3 "_ednref3")

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To further evaluate the combination of Leukine plus Rituxan, researchers have initiated a clinical trial for patients with follicular lymphoma whose cancer has progressed following prior therapy, including Rituxan. One group of patients in the trial will be treated with Leukine plus Rituxan, and the other group will be treated with Rituxan alone. Patients will be assessed according to how their cancer responds to treatment.

For more information on enrollment for this clinical trial, go to www.eCancerTrials.com and choose clinical trials for low-grade non-Hodgkin’s lymphoma. The title of the trial is “A Randomized, open-label, phase II trial comparing rituximab plus sargramostim to rituximab monotherapy for the treatment of relapsed follicular B-cell lymphoma”.

References:

[[1]](http://news.cancerconnect.com/novel-treatment-strategy-evaluating-rituxan-plus-leukine-in-lymphoma-patients-begining-clinical-trials/#_ednref1 "_edn1") Berlex Pharmaceuticals. Berlex Oncology Evaluating Combination Therapy for Common Form of Non-Hodgkin’s Lymphoma. Available at: http://www.berlex.com/html/press/articles/10312006.html. Accessed November 2006.

[[2]](http://news.cancerconnect.com/novel-treatment-strategy-evaluating-rituxan-plus-leukine-in-lymphoma-patients-begining-clinical-trials/#_ednref2 "_edn2") Hernandez-Ilizaliturri F, Jupudy V, Reising S, et al. Concurrent Administration of Granulocyte Colony-Stimulating Factor or Granulocyte-Monocyte Colony-Stimulating Factor Enhances the Biological Activity in Rituximab in a Severe Combined Immunodeficiency Mouse Lymphoma Mode. Leukemia and Lymphoma. 2005;46:1775-1784.

[[3]](http://news.cancerconnect.com/novel-treatment-strategy-evaluating-rituxan-plus-leukine-in-lymphoma-patients-begining-clinical-trials/#_ednref3 "_edn3") Ragnhammar P, Frodin J, Trotta P, Mellstedt H. Cytotoxicity of White Blood Cells Activated by Granulocyte-Colony-Stimulating Factor, Granulocyte/Macrophage-Colony-Stimulating Factor and Macrophage-Colony-Stimulating Factor Against Tumor Cells in the Presence of Various Monoclonal Antibodies. Cancer Immunol Immunother. 1994;39:254-262.

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