Chronic Lymphocytic Leukemia, Leukemia, Neoplasms
Conditions
Brief summary
The purpose of this study is to determine whether bendamustine is effective in the treatment of initial treatment of Chronic Lymphocytic Leukemia (CLL).
Interventions
DRUGChlorambucil
Sponsors
Shandong Lanjin Pharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival(PFS) | 24 months |
| Duration of Response (DR) | 24 months |
| Overall Survival(OS) | 24 months |
Countries
China
Contacts
Primary ContactLu G Qiu, M.D.
Backup ContactJian J Yu, Master
Outcome results
None listed