A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.
Status:
Completed
Trial end date:
2013-01-14
Target enrollment:
Participant gender:
Summary
This single arm study will assess the efficacy and safety of MabThera + chlorambucil as
induction therapy, followed in responders by maintenance therapy or observation in elderly
patients with previously untreated chronic lymphocytic leukemia. During the induction phase
patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses
of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses
of MabThera given every 8 weeks, or no further treatment. The anticipated time on study
treatment is 2+ years, and the target sample size is <100 individuals.