A Study of MabThera (Rituximab) Plus Chlorambucil in Participants With Chronic Lymphocytic Leukemia.
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
This single arm study will assess the safety and effect on response rate of a combination of
rituximab and chlorambucil in previously untreated participants with B-cell chronic
lymphocytic leukemia. Participants will receive 6 monthly cycles of combination treatment,
followed by up to 6 cycles of chlorambucil alone. Rituximab will be administered on Day 1 of
each cycle, at a dose of 375 milligrams per square meter (mg/m^2) intravenously (IV) in Cycle
1, and 500 mg/m^2 in subsequent cycles, and chlorambucil will be administered on Days 1-7 of
each cycle at a dose of 10 mg/m^2/day per oral (PO).