Leukemia Clinical Trial
Official title:
A CRC Trial of Rituximab in Combination With Sargramostim (GM-CSF) in Patients With Chronic Lymphocytic Leukemia
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells
and help kill them or carry cancer-killing substances to them. Colony-stimulating factors,
such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral
blood. Giving rituximab together with GM-CSF may be an effective treatment for chronic
lymphocytic leukemia.
PURPOSE: This phase II trial is studying how well giving rituximab together with GM-CSF
works in treating patients with B-cell chronic lymphocytic leukemia.
OBJECTIVES:
- 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
disease status
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
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