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

Summary

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

Timeline

Start

2006-05

Primary completion

2009-06

Completion

2009-06

Outcome

Missed primary endpoint

Stopped (Enrollment): “Terminated by sponsor due to low enrollment; see details below”

registry analysis (superiority or other test); Rituximab vs Rituximab + Sargramostim; p = 0.6182; 2-sided Exact Conditional Test NCT00308087 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sargramostim	Protein / enzyme biologic	250 ug	Subcutaneous
Background	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous

Indications