Pentostatin and Rituximab for CLL or Low-Grade B-Cell NHL

Pan-Pacific Lymphoma Conference, Mauna Lani, Hawaii, July 2003
American Society of Hematology Annual Meeting, Atlanta, GA, December 2005

R Mena, J Smith, G Geils, G Geils, Jr., F Yunus, D Nyman, S George East Valley Hem/Onc Medical Group, Burbank, CA; Cancer and Blood Institute of the Desert, Rancho Mirage, CA; Charleston Hem/Onc, Charleston, SC; Pharmatech Oncology, Inc., Denver, CO; University of TN Cancer Institute, Memphis, TN

Background

Recent studies have suggested that combination chemotherapy with a purine analog and a monoclonal antibody may have additive as well as synergistic activity in the treatment of NHL and CLL. The first immunochemotherapeutic regimen combined fludarabine (F) and rituximab (R). Although it was efficacious, it was also myelotoxic and immunosuppressive. This multicenter Phase II trial investigated the efficacy and safety of another purine analog, pentostatin (P), in combination with R in the treatment of NHL and CLL patients.

Methods

One hundred forty-seven patients were enrolled in this study. Eligibility criteria allowed previously treated (PT) and treatment naïve (UT) patients diagnosed with low-grade NHL (REAL classification) or stage II, III, or IV CLL (mod. Rai staging). Treatment consisted of intravenous infusions of R (375 mg/mg²) on day 1 and R (375 mg/mg²) plus dose intensive P (4 mg/mg²) on days 8, 15, 22, 36, 43, and 50, completing 1 cycle. Clinical evaluation was performed after 60 days. If complete response was determined, the treatment was stopped. All other patients then received cycle 2. Patients were stratified by disease and by prior treatment status.