Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Bendamustine Hydrochloride; Chlorambucil

Criteria

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