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