drugset / Trial / NCT00558181
High-dose Methylprednisolone and Rituximab in High Risk B-CLL
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Studies have shown that both high-dose Methylprednisolone and Rituximab used as single agents are effective in relapsed and refractory B-CLL. Methylprednisolone acts independently of p53 apoptosis pathway. The combination of both drugs may improve response and outcome in previously treated high-risk B-CLL patients. Study Objectives Primary: To determine the clinical benefit of high-dose Methylprednisolone and Rituximab in previously treated high-risk B-CLL patients in terms of clinical and flowcytometric response rate. Secondary: To determine progression free and overall survival. To characterize the safety profile of high-dose Methylprednisolone and Rituximab.
Timeline
- Start
- 2007-09
- Primary completion
- 2009-01
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylprednisolone | Other / unclassified | — | Intravenous |
| Subject | Rituximab | Monoclonal antibody | — | Intravenous |