NCT00558181

High-dose Methylprednisolone and Rituximab in High Risk B-CLL

Phase II Study of High-dose Methylprednisolone and Rituximab in Previously Treated Patients With High Risk Chronic B Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Vilnius University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Patient Population Patients with previously treated symptomatic high risk B-CLL 18 years of age and older. Study Duration The study period for each subject is expected to be 21 months. Subjects will receive up-to 6 cycles of IV infusion of Methylprednisolone and Rituximab. Maximum duration of treatment is expected to be 9 months. All infusions of study treatment will be administered by medically qualified site staff in an inpatient or outpatient clinic under the supervision of an Investigator. Subjects will complete scheduled visits not later than Study Month 21, after which time they will enter into the long term follow up period. Subjects will be followed every 3 months for disease progression, initiation of subsequent leukemia treatment or survival, except in cases lost to follow up, or if a subject withdraws informed consent. Study Design Phase II, multicenter, non-randomized, open label study. Maximum Recruitment Period 2 years Number of Planned Subjects Approximately 50 patients.

Conditions

• Chronic B-Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	rituximab, methylprednisolone	Subjects will receive up-to 6 courses of IV infusion of Methylprednisolone and Rituximab every 21 day.

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-01-01
• Completion: 2009-12-01
• First posted: 2007-11-14
• Last updated: 2010-02-23

Locations

2 sites across 1 country: Lithuania