High-dose Methylprednisolone and Rituximab in High Risk B-CLL
- Sponsor
- Vilnius University
- Study ID
- NCT00558181
- Phase
- PHASE2
- Status
- Completed
Conditions
- Chronic B-Lymphocytic Leukemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- rituximab, methylprednisolone — DRUGSubjects will receive up-to 6 courses of IV infusion of Methylprednisolone and Rituximab every 21 day.
Study Details
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.
Key Dates
- Start date
- Sep 30, 2007
- Status verified
- Feb 2010
- Primary completion
- Jan 31, 2009
- Completion
- Dec 31, 2009
Study Design
- Enrollment
- 29 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Rituximab, Methylprednisolone
Primary Outcome Measure
Primary endpoint will be the ORR defined as the proportion of patients achieving CR, CR with MRD negativity (Complete Flow Cytometric Remission), nPR and PR. [ Time Frame: End of treatment. ]