A CRC Trial of Rituximab in Combination With Sargramostim (GM-CSF) in Patients With Chronic Lymphocytic Leukemia
- Determine the complete and overall response rate in patients with B-cell chronic
lymphocytic leukemia treated with rituximab and sargramostim (GM-CSF).
- Determine the time to progression in patients treated with this regimen.
- Determine the effects of this regimen on CD20 antigen expression and soluble CD20
levels in these patients.
OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to
Patients receive rituximab IV on days 4, 11, 18, and 25 and sargramostim (GM-CSF)
subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, 40,
43, 45, 47, 50, 52, and 54 (course 1). Patients with responding disease may receive an
additional course of treatment.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.
Primary Purpose: Treatment
Overall response rate
Ian W. Flinn, MD, PhD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government