drugset / Trial / NCT00562328
Rituximab, Alemtuzumab, and GM-CSF As First-Line Therapy in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia
NaSingle-groupOpen-labelTreatment
Summary
RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, 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 monoclonal antibody therapy together with GM-CSF may be an effective treatment for early-stage chronic lymphocytic leukemia. PURPOSE: This phase II trial is studying the side effects of giving rituximab and alemtuzumab together with GM-CSF and to see how well it works in treating patients with early-stage chronic lymphocytic leukemia.
Timeline
- Start
- 2008-01
- Primary completion
- 2010-02-05
- Completion
- 2014-12-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alemtuzumab | Monoclonal antibody | 30 mg | Subcutaneous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | sargramostim | Protein / enzyme biologic | 250 ug | Subcutaneous |