According to the results of a Phase III clinical trial, treatment with the experimental drug Mozobil™ (plerixafor) increases the number of stem cells that can be collected from patients with non-Hodgkin’s lymphoma who are preparing for an autologous hematopoietic stem-cell transplant.
Non-Hodgkin’s lymphoma (NHL) is a form of cancer that begins in the cells of the lymph system, which includes the spleen, thymus, tonsils, bone marrow, lymph nodes, and circulating immune cells. Lymphocytes are the main cells in the lymph system and exist in two forms: B- and T-cells. Each of these cells serves a specific function in aiding the body fight infection. In NHL an excessive amount of atypical (cancerous) lymphocytes accumulates in the lymph system.
Depending on the type and stage of NHL, treatment may involve high-dose chemotherapy with autologous stem cell transplantation. High-dose chemotherapy generally kills more cancer cells than standard-dose chemotherapy, but also kills more healthy cells. Hematopoietic stem cells (immature blood cells) are particularly vulnerable to high-dose therapy.
To replace hematopoietic stem cells that are destroyed during high-dose cancer therapy, patients often receive a hematopoietic stem cell transplant. An autologous hematopoietic stem cell transplant makes use of a patient’s own stem cells. The stem cells are collected prior to therapy and stored, then administered to the patient after high-dose therapy.
Prior to stem cell collection, the patient may be treated with a drug known as a granulocyte colony stimulating factor (G-CSF) in order to increase the number of available stem cells. In order to evaluate whether the addition of Mozobil to G-CSF improved stem cell collection compared to G-CSF alone, researchers conducted a Phase III clinical trial among 298 patients with non-Hodgkin’s lymphoma.
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- Patients treated with G-CSF and Mozobil were three times more likely than patients treated with G-CSF alone to reach the target threshold for collection with four or fewer days of blood removal and separation (apheresis).
- Mozobil was generally well tolerated. The most common adverse effects of treatment were mild gastrointestinal effects and redness at the injection site. Serious adverse effects occurred in two patients treated with G-CSF and Mozobil and one patient treated with G-CSF alone.
Based on these results, the company that makes Mozobil plans to apply for approval of the drug.
Reference: Genzyme Corp. Press Release. Genzyme Announces Phase 3 Trial of Mozobil in non-Hodgkin’s Lymphoma Meets Primary Endpoint. July 19, 2007. Available at: http://www.genzyme.com/corp/investors/GENZ%20PR-071907.asp (Accessed July 31, 2007).
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