A phase II study of chlorambucil plus rituximab followed by maintenance versus observation in elderly patients with previously untreated chronic lymphocytic leukemia: Results of the induction phase.

6629 Background: The FCR regimen (fludarabine, cyclophosphamide, rituximab) significantly improves the outcome of patients (pts) with chronic lymphocytic leukemia (CLL). However, myelotoxicity and immunosuppression are a limitation to the use of this regimen in elderly patients and in those with co-morbidities. The combination of rituximab (R) with chlorambucil (CLB; R-CLB) is an attractive therapeutic option for this subset of patients considering the expected good tolerability and potentially increased activity of this schedule. This study was designed to determine whether the R-CLB combination is a feasible and beneficial first-line treatment for elderly patients with CLL and to define the role of maintenance with R. Methods: 97 elderly patients requiring first-line therapy received CLB (8 mg/m²/day p.o., d1-d7, courses 1-8) and R (375 mg/m², course 3 and 500 mg/m², courses 4-8) every 28 days. Responsive patients were subsequently randomized to receive R maintenance (375 mg/m² every 2 months for 2 year...