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

• Status: Terminated
• Trial end date: 2016-03-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Chlorambucil; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab; Vidarabine

Criteria

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