A Study of Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.

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

Details

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

Criteria

Inclusion Criteria:

• Adult participants greater than or equal to (≥) 18 years of age

• B-cell CLL

• No previous treatment for leukemia

Exclusion Criteria:

• History of other malignancies within 2 years before study entry, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer

• Comorbid condition requiring long-term (greater than [>] 1 month) systemic corticosteroids during study treatment

• Known infection with hepatitis B or C virus or with human immunodeficiency virus (HIV)