High-dose Methylprednisolone and Rituximab in High Risk B-CLL
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
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.