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Sponsor: Hoffmann-La Roche
Conditions: Lymphocytic Leukemia, Chronic
Interventions: rituximab [MabThera/Rituxan], chlorambucil
Countries: Italy
This single arm study will assess the efficacy and safety of MabThera + chlorambucil as induction therapy, followed in responders by maintenance therapy or observation in elderly patients with previously untreated chronic lymphocytic leukemia. During the induction phase patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses of MabThera given every 8 weeks, or no further treatment. The anticipated time on study treatment is 2+ years, and the target sample size is \<100 individuals.
Sex: ALL
Age: 60 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * adult patients, \>=60 years of age; * CD20+ chronic lymphocytic leukemia (CLL); * no previous treatment for CLL; * ECOG performance status 0-1. Exclusion Criteria: * co-morbid conditions requiring long term use of systemic corticosteroids during study treatment; * history of severe cardiac disease; * transformation to aggressive B-cell malignancy.
- Bari, Apulia, Italy
- Catanzaro, Calabria, Italy
- Cosenza, Calabria, Italy
- Reggio Calabria, Calabria, Italy
- Naples, Campania, Italy
- Bologna, Emilia-Romagna, Italy
- Ferrara, Emilia-Romagna, Italy
- Rome, Lazio, Italy
- Rome, Lazio, Italy
- Genoa, Liguria, Italy
- Milan, Lombardy, Italy
- Milan, Lombardy, Italy
- Turin, Piedmont, Italy
- Turin, Piedmont, Italy
- Messina, Sicily, Italy
- Via S. Sofia 78, Sicily, Italy
- Florence, Tuscany, Italy
- Siena, Tuscany, Italy
- Padova, Veneto, Italy
- Verona, Veneto, Italy