Phase II Study of High-dose Methylprednisolone and Rituximab in Previously Treated Patients With High Risk Chronic B Lymphocytic Leukemia
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.
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
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
Study Design Phase II, multicenter, non-randomized, open label study.
Maximum Recruitment Period 2 years
Number of Planned Subjects Approximately 50 patients.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
End of treatment.
Laimonas Griskevicius, PhD, MD
Lithuania: Bioethics Committee