drugset / Trial / NCT00381004
FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide, and rituximab, with sargramostim (GM-CSF) can help to control previously untreated chronic lymphocytic leukemia (CLL). The safety of this combination will also be studied. This study will evaluate antibody-dependent cellular cytotoxicity (ADCC) and its relationship to response.
Timeline
- Start
- 2006-09
- Primary completion
- 2014-12
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 250 mg/m2 | Intravenous |
| Subject | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | sargramostim | Protein / enzyme biologic | 250 ug/m2 | Subcutaneous |