Pentostatin, Cyclophosphamide And Rituximab (PCR) For B-Cell Chronic Lymphocytic Leukemia (CLL) And Small B-Cell Lymphocytic Lymphoma (SLL): Four Phase II Trials With Patient Stratification Based On Prior Therapy
- Determine the efficacy of pentostatin, cyclophosphamide, and rituximab, in terms of
response rate, time to treatment failure, time to disease progression, durability of
response, and overall survival, in patients with B-cell chronic lymphocytic leukemia or
small B-cell lymphocytic lymphoma.
- Determine the safety of this regimen, in terms of acute, subacute, and chronic
toxicity, in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (no prior chemotherapy for chronic lymphocytic leukemia vs prior purine
analog-based therapy [fludarabine or cladribine] but no alkylator therapy vs prior
alkylator-based therapy [chlorambucil or cyclophosphamide] but no prior purine analog
therapy vs prior therapy with alkylators and purine analogs, but not as combination
- First course: Patients receive rituximab IV over 1-4 hours on days 1-3 and pentostatin
IV over 10-30 minutes and cyclophosphamide IV over 30-60 minutes on day 1.
- All subsequent courses: Patients receive rituximab IV over 60 minutes, pentostatin IV
over 10-30 minutes, and cyclophosphamide IV over 30-60 minutes on day 1. Treatment
repeats every 3 weeks for up to 6 courses in the absence of disease progression or
Patients are followed every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 160-240 patients (40-60 per stratum) will be accrued for this
Masking: Open Label, Primary Purpose: Treatment
Robert O. Dillman, MD, FACP
Hoag Memorial Hospital Presbyterian
United States: Federal Government
|Hoag Cancer Center at Hoag Memorial Hospital Presbyterian||Newport Beach, California 92663|