Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Inclusion Criteria:

• Patients must have a diagnosis of CLL;
• No prior or no standard treatment for CLL;
• Binet stage B, C or symptomatic stage A;
• Needs treatment to control diseases;
• (Eastern Cooperative Oncology Group)ECOG performance status ≤ 2
• Life expectancy ≥3 months
• Written informed consent

Exclusion Criteria:

• Patients were diagnosed with or treated for malignant tumors other than CLL (including active central nervous system lymphoma) within one year prior to entering the study
• Transformation to Richter's syndrome, or prolymphocytic leukemia(PLL)
• Autoimmune hemolytic anemia requiring glucocorticoid therapy
• Autoimmune thrombocytopenia requiring glucocorticoid therapy
• Alanine aminotransferase(ALT)>3 times upper limits of normal value, Aspartate aminotransferase(AST)>3 times upper limits of normal value, Total bilirubin(TBIL)>2 times upper limits of normal value, serum creatinine>1.5 times upper limits of normal value;
• Other serious Concomitant diseases which affect participation of this study(uncontrolled diabetes, gastric ulcer, cardiac and pulmonary diseases, at active phases of autoimmune diseases;
• Serious or uncontrolled infections;
• Central nervous system dysfunction with clinical symptoms;
• Patients received major surgery within 30 days prior to study entry;
• Pregnant or lactating women
• Allergic to study drug or mannitol
• Participation in any other clinical trials within 3 months prior to study entry