RITUXIMAB IN COMBINATION WITH HIGH DOSE METHYLPREDNISOLONE FOR THE TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA

We observed that high-dose methylprednisolone (HDMP) and rituximab (R) was well tolerated and had promising activity when used in combination to treat patients with fludarabine-refractory chronic lymphocytic leukemia (CLL). This prompted us to evaluate the use of these agents in frontline therapy. Twenty-eight patients with a median age of 65 enrolled in this study. Patients received HDMP at 1 g/m(2) each day for three days during each of the three four-week cycles together with rituximab and prophylactic anti-microbial therapy. The treatment was well tolerated with few adverse events of grade III or higher. The overall response rate was 96% (N=27). Nine patients (32%) achieved a complete remission (CR), two of which were without detectable minimal residual disease (MRD). Six patients with MRD received consolidation with alemtuzumab; five of these patients achieved an MRD-negative CR. With over three years of follow-up median progression free survival was 30.3 months with only 39% of patients requiring additional therapy, and an overall survival was 96%. This study demonstrates that HDMP and rituximab is an effective non-myelosuppressive treatment combination for patients with CLL that warrants consideration particularly for patients with limited myeloid reserve that might not tolerate standard treatment regimens.