CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy

• Status: Completed
• Trial end date: 2012-09-24
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• B-cell CLL

• No previous chemotherapy, radiotherapy, or immunotherapy

Exclusion Criteria:

• Reduced organ function, or bone marrow dysfunction not due to CLL

• Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer

• Patients with a history of severe cardiac disease.