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Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Primary Purpose

Chronic Lymphocytic Leukemia, Leukemia, Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Bendamustine Hydrochloride Injection
Chlorambucil
Sponsored by
Shandong Lanjin Pharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must have a diagnosis of CLL;
  • No prior or no standard treatment for CLL;
  • Binet stage B, C or symptomatic stage A;
  • Needs treatment to control diseases;
  • (Eastern Cooperative Oncology Group)ECOG performance status ≤ 2
  • Life expectancy ≥3 months
  • Written informed consent

Exclusion Criteria:

  • Patients were diagnosed with or treated for malignant tumors other than CLL (including active 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
  • Alanine aminotransferase(ALT)>3 times upper limits of normal value, Aspartate aminotransferase(AST)>3 times upper limits of normal value, Total bilirubin(TBIL)>2 times upper limits of normal value, serum creatinine>1.5 times upper limits of normal value;
  • Other serious Concomitant diseases which affect participation of this study(uncontrolled diabetes, gastric ulcer, cardiac and pulmonary diseases, at active phases of autoimmune diseases;
  • Serious or uncontrolled infections;
  • Central nervous system dysfunction with clinical symptoms;
  • Patients received major surgery within 30 days prior to study entry;
  • Pregnant or lactating women
  • Allergic to study drug or mannitol
  • Participation in any other clinical trials within 3 months prior to study entry

Sites / Locations

  • Hematologic hospital of Chinese academy of medical sciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bendamustine Hydrochloride Injection

Chlorambucil

Arm Description

d1-d2,i.v.gtt, 100mg/m2/d, 28 days per cycle, at most 6 cycles.

d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles(if WBC≥4×109 /L at d12-d14 ); d1-d2, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles(if WBC<4×109 /L at d12-d14 );

Outcomes

Primary Outcome Measures

Overall response rate (ORR)

Secondary Outcome Measures

Progress free survival(PFS)
Duration of Response (DR)
Overall Survival(OS)

Full Information

First Posted
August 2, 2012
Last Updated
August 3, 2012
Sponsor
Shandong Lanjin Pharmaceuticals Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01657955
Brief Title
Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia
Acronym
CLL
Official Title
Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong Lanjin Pharmaceuticals Co.,Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether bendamustine is effective in the treatment of initial treatment of Chronic Lymphocytic Leukemia (CLL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Leukemia, Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bendamustine Hydrochloride Injection
Arm Type
Experimental
Arm Description
d1-d2,i.v.gtt, 100mg/m2/d, 28 days per cycle, at most 6 cycles.
Arm Title
Chlorambucil
Arm Type
Active Comparator
Arm Description
d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles(if WBC≥4×109 /L at d12-d14 ); d1-d2, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles(if WBC<4×109 /L at d12-d14 );
Intervention Type
Drug
Intervention Name(s)
Bendamustine Hydrochloride Injection
Intervention Type
Drug
Intervention Name(s)
Chlorambucil
Other Intervention Name(s)
Leukeran
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Progress free survival(PFS)
Time Frame
24 months
Title
Duration of Response (DR)
Time Frame
24 months
Title
Overall Survival(OS)
Time Frame
24 months

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; No prior or no standard treatment for CLL; Binet stage B, C or symptomatic stage A; Needs treatment to control diseases; (Eastern Cooperative Oncology Group)ECOG performance status ≤ 2 Life expectancy ≥3 months Written informed consent Exclusion Criteria: Patients were diagnosed with or treated for malignant tumors other than CLL (including active 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 Alanine aminotransferase(ALT)>3 times upper limits of normal value, Aspartate aminotransferase(AST)>3 times upper limits of normal value, Total bilirubin(TBIL)>2 times upper limits of normal value, serum creatinine>1.5 times upper limits of normal value; Other serious Concomitant diseases which affect participation of this study(uncontrolled diabetes, gastric ulcer, cardiac and pulmonary diseases, at active phases of autoimmune diseases; Serious or uncontrolled infections; Central nervous system dysfunction with clinical symptoms; Patients received major surgery within 30 days prior to study entry; Pregnant or lactating women Allergic to study drug or mannitol Participation in any other clinical trials within 3 months prior to study entry
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu G Qiu, M.D.
Phone
+86-02223909172
First Name & Middle Initial & Last Name or Official Title & Degree
Jian J Yu, Master
Phone
+86-15336402751
Email
yujj@lanjin.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lu G Qiu, M.D.
Organizational Affiliation
Hematologic Hospital of Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematologic hospital of Chinese academy of medical sciences
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu G Qiu, M.D.
Ext
+8602223909172
First Name & Middle Initial & Last Name & Degree
Jian J Yu, Master
Phone
+8615336402752
Email
yujj@lanjin.cn
First Name & Middle Initial & Last Name & Degree
Lu G Qiu, M.D.

12. IPD Sharing Statement

Links:
URL
http://lanjin.cn
Description
Related Info

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Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia

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