Trial Information

Summary: A Phase 2 study comparing rituximab plus sargramostim to rituximab monotherapy for treatment of relapsed, follicular B-cell lymphoma.

This is an open-label, randomized study in patients with relapsed, follicular B cell lymphoma. This study will investigate the efficacy and safety of repeat doses of sargramostim and rituximab when compared to rituximab monotherapy. This study will enroll 196 subjects from approximately 40 sites in the U.S.

Rituximab is a monoclonal antibody that is approved by the FDA for the treatment of relapsed or refractory follicular B-cell lymphoma. The study drug sargramostim is a synthetic human 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. This 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.

This study is specifically for adults who meet the following criteria:

• At least 18 years old
• Must have histologically confirmed follicular B-cell lymphoma
• Must have a B-cell population which is CD-20 positive
• Must have received prior therapy for this condition
• May have previously received rituximab alone or in combination but must not have proven refractory to rituximab by relapsing within 6 months of treatment with this agent
• Must not have CNS lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma,or a diagnosis of previous hematological malignancy
• No prior therapy for at least 3 weeks in general

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.