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PREMIER: Primary Evaluation Measuring Improved Efficacy of Rituximab with Sargramostim
What is non-Hodgkins lymphoma?
Why is the study being conducted?
Who can participate?
How will participants benefit?
What is a clinical trial?
Health Care Professionals

What is non-Hodgkin's lymphoma?

Follicular B-cell lymphoma, which is a type of NHL, is classed as a low grade (indolent) lymphoma and has a relatively slow rate of progression. Currently there are no standard treatments for this type of lymphoma.

Depending on the extent of the disease, treatment options include 'watchful waiting', radiation, chemotherapy, immunotherapy, radio-immunotherapy and combinations of these treatments. Using these therapies the interval between disease progressions (remissions) has been extended. Additional re-treatments are typically associated with a lower chance for survival and shorter remissions.

The long term side effects of chemotherapies, radio-immunotherapies, and chemo-radiation are unknown and may include the risk of developing other cancers of the blood.

Rituximab (Rituxan®) is a monoclonal antibody that is approved by the FDA for the treatment of relapsed or refractory follicular B-cell lymphoma. Rituxan® is a registered trademark of Biogen Idec. It has been used successfully, both alone and in combination with standard chemotherapy. Rituximab attaches to the cells that cause the lymphoma and signals the immune system to destroy them. Most of the time, side effects with rituximab are mild to moderate.

The study drug sargramostim is a synthetic granulocyte macrophage-colony stimulating factor (GM-CSF). It stimulates the bone marrow to make new white blood cells and may also stimulate the body's immune system.

The PREMIER research study will determine if the study drug sargramostim boosts the effects of rituximab allowing the patient a complete remission and extended period to relapse with fewer long term side effects.

 
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