Conditions: Lymphoma, Follicular
Keywords: Sargramostim Leukine NHL
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 75
Healthy volunteers: no

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

Detailed description:
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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Sargramostim (Leukine) intervention 2: Rituximab
Intervention descriptions: intervention 1: Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab intervention 2: Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks

Protocol document: