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

Phase 2
18 Years
75 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia

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Trial Information

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

Patients will be assessed for response after three cycles of treatment. Two additional
cycles are recommended for CR, PR or SD patients, up to a maximum limit of six cycles in
total. Patients will be followed up every three months until disease progression or death.

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Objective Response Rate (ORR)

Outcome Time Frame:

after 3 cycles and 6 cycles

Safety Issue:


Principal Investigator

Zhixiang Shen, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine


China: Food and Drug Administration

Study ID:




Start Date:

March 2010

Completion Date:

December 2013

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Chronic Lymphocytic Leukemia
  • Bendamustine Hydrochloride
  • Chlorambucil
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid