Conditions: Lymphocytic Leukemia, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 357
Healthy volunteers: no

Brief summary:
This randomized, open-label, parallel group study will assess the effect on response rate and the safety of MabThera added to either bendamustine or chlorambucil in patients with chronic lymphocytic leukemia. Patients will be randomized to receive six 4-week cycles of either A) MabThera (375mg/m2 iv day 1 of cycle 1, 500mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as first-line or 70mg/m2 as second-line therapy, iv on days 1 and 2, cycles 1-6), or B)MabThera plus chlorambucil (10mg/m2 po daily, days 1-7, cycles 1-6). Patients in group B can receive up to 6 further cycles of chlorambucil as monotherapy. Anticipated time on study treatment is 6-12 months, and target sample size is 600-700 individuals.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: bendamustine intervention 2: chlorambucil intervention 3: rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: 90mg/m2 (first-line) or 70mg/m2 (second-line) iv, days 1 and 2 every 4 weeks, cycles 1-6 intervention 2: 10mg/m2 po days 1-7 every 4 weeks, for up to 12 cycles intervention 3: 375mg/m2 iv day 1 of cycle 1, followed by 500mg/m2 iv every 4 weeks cycles 2-6

Protocol document: