Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients

To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia

Patients will be assessed for response after three cycles of treatment. Two additional cycles are recommended for CR, PR or SD patients, up to a maximum limit of six cycles in total. Patients will be followed up every three months until disease progression or death.

Inclusion Criteria:

• Patients must have a diagnosis of CLL according to National Cancer Institute (NCI) Working Group criteria
• No prior treatment for CLL
• Binet stage B or C
• ECOG performance status ≤ 2
• Life expectancy ≥3 months
• AST and ALT ≤ 3 x ULN; Total bilirubin ≤ 2 x ULN; Creatinine clearance ≥ 40 mL/min
• Written informed consent

Exclusion Criteria:

• Patients were diagnosed with or treated for malignant tumors other than CLL (including 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
• Participation in any other clinical trials within 4 weeks prior to study entry
• Any of the following conditions: severe heart failure; cardiomyopathy; myocardial infarction within 6 months; severe, uncontrolled diabetes; severe, uncontrolled hypertension; active, uncontrolled infection; central nervous system dysfunction
• Patients received major surgery within 30 days prior to study entry
• Pregnant or lactating women
• Allergic to study drug or mannitol