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Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bendamustine hydrochloride injection
Chlorambucil
Sponsored by
Jiangsu Simcere Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Chronic Lymphocytic Leukemia, Bendamustine Hydrochloride, Chlorambucil

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bendamustine Hydrochloride

Chlorambucil

Arm Description

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

Secondary Outcome Measures

Progression-free Survival (PFS)
Duration of Remission (DR)
Overall Survival (OS)
The incidence and severity of adverse events

Full Information

First Posted
April 19, 2010
Last Updated
August 21, 2013
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01109264
Brief Title
Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia
Official Title
Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
Chronic Lymphocytic Leukemia, Bendamustine Hydrochloride, Chlorambucil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bendamustine Hydrochloride
Arm Type
Experimental
Arm Title
Chlorambucil
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bendamustine hydrochloride injection
Intervention Description
d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles
Intervention Type
Drug
Intervention Name(s)
Chlorambucil
Intervention Description
d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
after 3 cycles and 6 cycles
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Time Frame
December 2013
Title
Duration of Remission (DR)
Time Frame
December 2013
Title
Overall Survival (OS)
Time Frame
December 2013
Title
The incidence and severity of adverse events
Time Frame
Up to 2 years after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhixiang Shen, Dr.
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine
City
Shanghai
Country
China

12. IPD Sharing Statement

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Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

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