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

Phase 3
18 Years
75 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia, Leukemia, Neoplasms

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Trial Information

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (ORR)

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Lu G Qiu, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hematologic Hospital of Chinese Academy of Medical Sciences


China: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

December 2013

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Neoplasms
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid