Conditions: Lymphocytic Leukemia, Chronic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 97
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: chlorambucil
Intervention descriptions: intervention 1: 375mg/m2 iv on day 1 of course 3; 500mg/m2 iv on day 1 of courses 4-8 (induction phase); 375mg/m2 iv every 8 weeks (maintenance phase). intervention 2: 8mg/m2 po on days 1-7 of courses 1-8

Protocol document: