Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether bendamustine is effective in the treatment of initial treatment of Chronic Lymphocytic Leukemia (CLL).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd
• Treatments: Bendamustine Hydrochloride; Chlorambucil

Criteria

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