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Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

This study has been completed.
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd. Identifier:
First received: April 19, 2010
Last updated: August 21, 2013
Last verified: August 2013
To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia

Condition Intervention Phase
Chronic Lymphocytic Leukemia Drug: Bendamustine hydrochloride injection Drug: Chlorambucil Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients

Resource links provided by NLM:

Further study details as provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: after 3 cycles and 6 cycles ]

Secondary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: December 2013 ]
  • Duration of Remission (DR) [ Time Frame: December 2013 ]
  • Overall Survival (OS) [ Time Frame: December 2013 ]
  • The incidence and severity of adverse events [ Time Frame: Up to 2 years after enrollment ]

Enrollment: 147
Study Start Date: March 2010
Study Completion Date: August 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bendamustine Hydrochloride Drug: Bendamustine hydrochloride injection
d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles
Active Comparator: Chlorambucil Drug: Chlorambucil
d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01109264

Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, China
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Principal Investigator: Zhixiang Shen, Dr. Ruijin Hospital
  More Information

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd. Identifier: NCT01109264     History of Changes
Other Study ID Numbers: SIM-79-001
Study First Received: April 19, 2010
Last Updated: August 21, 2013

Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
Chronic Lymphocytic Leukemia
Bendamustine Hydrochloride

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Bendamustine Hydrochloride
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on September 19, 2017