PHASE III, OPEN-LABEL, RANDOMIZED, MULTICENTER EFFICACY AND

INTERVENTION: Trade Name: Ribomustin Product Name: Ribomustin Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Bendamustin CAS Number: 16506‐27‐7 Other descriptive name: Bendamustin hydrochlorid Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 25 and 100‐ Trade Name: Leukeran 2 mg Filmtabletten Product Name: Chlorambucil Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Chlorambucil CAS Number: 305‐03‐3 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 2‐ CONDITION: Hematopoietic insufficiency with non‐hemolysis‐induced Hb <10 g/dL Thrombocytopenia <100x109/L (equivalent to Binet stage C) B symptoms Rapidly progressive disease (such as rapid lymphoma growth, rapid increase in lymphocyte count, rapid fall in Hb or platelet count not due to autoimmune phenomena) Risk of organ complications from bulky lymphomas. B symptoms are defined as unexplained > 10% weight loss in the last 6 months, persistent or recurrent FUO >38°C, night sweats. ; MedDRA version: 7 Level: LLT Classification code 10008956 PRIMARY OUTCOME: Main Objective: overall remission rate (CR/PR); progression free survival Primary end point(s): The primary endpoints of this Phase III study are the overall remission rate (CR+PR) and progression‐free survival in chemo‐naïve Binet stage B/C B‐CLL patients requiring therapy. Secondary Objective: time to progression; duration of remission; overall survival; infection rate; quality of life; side effects (toxicities) INCLUSION CRITERIA: Treatment‐naïve, legally competent adult patients = 75 years of age capable of following study instructions. Patient has given written informed consent (Appendix I). WHO Performance Status 0‐2 (Appendix III). Life expectancy = 3 months. Contraception for at least 6 months after therapy Confirmed chronic B‐cell lymphocytic leukemia (Coexpression of CD5, CD23 and either CD19 or CD20 or both). Symptomatic Binet stage B or Binet stage C of the disease requiring treatment acc. to the criteria defined by the NCIWG1996. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range