A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

Prospective Randomized Study to Compare Efficacy and Safety of RFC-Lite (Rituximab, Fludarabine, Cyclophosphamide) Regimen With LR (Rituximab, Chlorambucil) as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

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.

Inclusion Criteria:

• Adult patients, 60-70 or >70 years of age
• Cumulative Illness Rating Scale (CIRS) comorbidity score >/=7 if patient is 60-70 years old
• Previously untreated B-cell chronic lymphocytic leukemia
• Binet stage B, C or A with progression
• ECOG performance status 0-2

Exclusion Criteria:

• Small-cell lymphoma
• Autoimmune hemolytic anemia
• Concomitant malignant disease during enrollment, except for basal cell carcinoma of the skin
• Chemotherapy for concomitant malignant disease within 12 months prior to study enrollment
• Richter's syndrome