Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma

Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma

The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.

On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. As of 29 August 2009, Genzyme assumed responsibility for the close out of the study. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

The study was terminated early due to low enrollment; significant changes to the protocol would have been required to keep pace with the changing therapeutic landscape of indolent lymphoma.

Inclusion Criteria (abbreviated list):

• Relapsed follicular B-cell lymphoma
• One or more previous therapies for non-Hodgkin's
• At least one measurable tumor by CT scan or MRI
• Additional criteria to be determined at screening visit

Exclusion Criteria (abbreviated list):

• Rituximab refractory (less than 6 months from last treatment with rituximab to relapse)
• Currently receiving treatment for another cancer
• Infection currently being treated
• Active Hepatitis B
• History of HIV infection
• Pregnant
• Additional criteria to be determined at screening visit