Phase III, open-label, randomised, multicentre efficacy and safety study of bendamustine hydrochloride versus chlorambucil in treatment-naive patients with (Binet Stage B/C) chronic B-Cell Lymphocytic Leukaemia (B-CLL) requiring therapy

INTERVENTION: Arm A: Bendamustine 100 mg/m^2 days 1 + 2 repeated every 28 days Arm B: Chlorambucil 0.8 mg/kg (Broca's normal weight) day 1 + day 15 every 28 days CONDITION: B‐Cell Lymphocytic Leukaemia (B‐CLL) ; Cancer ; Leukaemia PRIMARY OUTCOME: 1. Overall response rate; 2. Progression‐free survival SECONDARY OUTCOME: 1. Time to progression; 2. Duration of response; 3. Overall survival; 4. Infection rate; 5. Quality of life; 6. Toxicity INCLUSION CRITERIA: 1. Treatment‐naive 2. Confirmed chronic B‐cell lymphocytic leukemia 3. Symptomatic Binet stage B or Binet stage C disease 4. Written informed consent 5. World Health Organization (WHO) performance status 0 ‐ 2 6. Life expectancy greater than 3 months