A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status

Prospective Study of Efficacy and Safety of RFC (Rituximab, Fludarabine, Cyclophosphamide) Regimen as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Favorable Somatic Status

This multi-center, single-arm study evaluated the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide in participants with B-cell chronic lymphocytic leukemia (CLL) and favorable somatic status.

Inclusion Criteria:

• Diagnosis of previously untreated B-cell CLL confirmed immunophenotypically
• For participants, age 60-70 years: Cumulative Illness Rating Scale (CIRS) comorbidity score less than or equal to (</=) 6
• Binet stage B, C or A with progression
• Life expectancy greater than or equal to (>/=) 12 months
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
• Women of child bearing potential and men should agree to use highly reliable contraceptive method throughout the treatment period and within 12 months after treatment completion

Exclusion Criteria:

• Participants with small-cell lymphoma
• Participants with auto-immune hemolytic anemia
• Concomitant malignant disease during enrollment, except basal cell carcinoma of the skin
• Chemotherapy for concomitant malignant disease given within 12 months prior to study enrollment
• Participants with Richter's Syndrome
• Participants with symptomatic Hepatitis B infection
• Any clinically significant infection that could not be cured prior to enrollment, including Human Immunodeficiency Virus (HIV) infection
• Creatinine clearance less than (<) 30 milliliters per minute (mL/min)
• Participants with congestive heart failure (CHF) New York Heart Association (NYHA) III-IV
• Participants with liver failure and acute hepatitis of any etiology
• Any other medical or mental condition which may preclude from receiving the entire course of protocol specified treatment or signing the informed consent
• History of an anaphylactic reaction to murine antibodies, proteins, or any other ingredient of rituximab
• Pregnancy and breast-feeding women