Extract

This multi-center, randomized study will compare the efficacy and safety of MabThera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in patients with previously untreated B-cell chronic lymphocytic leukemia and unfavourable somatic status. Patients will be 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 is 24 weeks.

Inclusion criteria

• Lymphocytic Leukemia, Chronic

Links

• ictrp
• nct