Conditions: Lymphocytic Leukemia, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 26
Healthy volunteers: no

Brief summary:
This multi-center, randomized study compared the efficacy and safety of MabThera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in participants with previously untreated B-cell chronic lymphocytic leukemia and unfavorable somatic status. Participants were randomized to receive Mabthera (375 mg/m2 intravenously \[IV\] Day 1 of Cycle 1, 500 mg/m2 IV Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 IV or 32 mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 IV or orally Days 1-3) or with chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study treatment was 24 weeks.

Detailed description:

Arms:
arm 1: Rituximab, fludarabine, and cyclophosphamide arm 2: Rituximab and chlorambucile

Interventions: intervention 1: Chlorambucil intervention 2: Cyclophosphamide intervention 3: Fludarabine intervention 4: Rituximab
Intervention descriptions: intervention 1: 10 mg/m\^2 orally on Days 1-7 of each 28-day cycle for 6 cycles intervention 2: 150 mg/m\^2 IV or orally on Days 1-3 of each 28-day cycle for 6 cycles intervention 3: 20 mg/m\^2 IV or 32 mg/m2 orally Days 1-3 of each 28-day cycle for 6 cycles intervention 4: 375 mg/m2 IV on Day 1 of Cycle 1; 500 mg/m2 IV on Day 1 of Cycles 2-6 (28-day cycles)

Protocol document: