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Sponsor: Hoffmann-La Roche
Conditions: Lymphocytic Leukemia, Chronic
Interventions: Cladribine, Cyclophosphamide, Rituximab
Countries: Belarus, Poland
This study will assess the effect of maintenance treatment with rituximab in comparison with observation period (no treatment), in participants with progressive B-cell CLL who have had previous first-line induction treatment with rituximab, cladribine and cyclophosphamide (RCC regimen). After 6 months of RCC induction therapy, participants will be randomized either to receive maintenance treatment with rituximab or to receive no treatment (observation only) for 96 weeks. Participants completing maintenance/observation period will be followed-up for approximately 3 years.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Immunologically confirmed diagnosis of B-cell CLL * Rai stage I-IV disease with evidence of progression * No previous chemotherapy, radiotherapy, or immunotherapy for B-cell CLL * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: * Active secondary malignancy or transformation to aggressive lymphoma * Medical condition requiring chronic use of oral corticosteroids at a dose of 1 mg/kg or 60 mg/m\^2 over 2 weeks * Prior treatment with interferon, rituximab or another monoclonal antibody, immunosuppressive treatment or radiotherapy before inclusion to the study * History of other malignancies within 2 years before study entry, except for dequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent
- Minsk, Belarus
- Bialystok, Poland
- Krakow, Poland
- Lodz, Poland
- Warsaw, Poland
- Wroclaw, Poland