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Sponsor: Hoffmann-La Roche
Conditions: Lymphocytic Leukemia, Chronic
Interventions: Chlorambucil, Cyclophosphamide, Fludarabine, Rituximab
Countries: Russia
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.
Sex: ALL
Age: 60 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Irkutsk, Russia
- Kemerovo, Russia
- Moscow, Russia
- Moscow, Russia
- Saint Petersburg, Russia
- Saint Petersburg, Russia
- Tula, Russia
- Ufa, Russia