Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01109264
First received: April 19, 2010
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: December 2013 ] [ Designated as safety issue: No ]
  • Duration of Remission (DR) [ Time Frame: December 2013 ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: December 2013 ] [ Designated as safety issue: No ]
  • The incidence and severity of adverse events [ Time Frame: Up to 2 years after enrollment ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109264

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

No publications provided

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01109264     History of Changes
Other Study ID Numbers: SIM-79-001
Study First Received: April 19, 2010
Last Updated: August 21, 2013
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Chlorambucil
Bendamustine
Nitrogen Mustard Compounds
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014