Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01109264
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : August 23, 2013
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief Summary:
To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Bendamustine hydrochloride injection Drug: Chlorambucil Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
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
Study Start Date : March 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
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

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

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd. Identifier: NCT01109264     History of Changes
Other Study ID Numbers: SIM-79-001
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: August 23, 2013
Last Verified: August 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