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Safety and Efficacy Study of Bendamustine to Treat Non-Hodgkin Lymphoma

Primary Purpose

Non-Hodgkin Lymphoma by Clinical Course

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

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma by Clinical Course focused on measuring Single arm, Open label, Bendamustine HCl, Non-hodgkin's lymphoma

Eligibility Criteria

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

Inclusion Criteria:

  • 18 to 75 years
  • B-cell indolent lymphoma proved by biopsy, exclude CLL/SLL
  • Rituximab refractory or relapsed lymphoma patients
  • At least 1 measurable tumor with shortest diameter being of > 1.0cm and longest diameter being of > 1.5cm
  • ECOG PS ≤ 2
  • Anticipated Survival is more than 3 months
  • Hematopoietic function is normal during 14 days before enrollment (unless those abnormities related to lymphoma aggression), including: hemoglobin (Hb) ≥ 8.0g/dl (5.0mmol/L); absolute neutrophil count (ANC) ≥ 1.5X109/L; Platelet count (PLT) ≥ 80X109/L. Acceptable range for abnormities related to lymphoma aggression: Platelet count (PLT) ≥ 50X109/L; White blood cell count (WBC) ≥ 3.5X109/L; Absolute neutrophil count (ANC) ≥ 1.0X109/L
  • Female subjects should not be pregnant and breast-feed, should have contraceptive method during the clinical trial and 12 months thereafter.
  • Subject (or his/her legal representative) agrees to participate the trial and sign the informed consent form

Exclusion Criteria:

  • Those who can not tolerate bendamustine treatment according to investigators view
  • Transferred to high grade malignant lymphoma (from low grade follicular lymphoma)
  • 3b grade follicular lymphoma
  • With central nervous system diseases or medical history (e.g., central nervous system lymphoma or lymphoma related meningitis )
  • With other anticancer treatment during the last 4 weeks
  • Regularly administrated corticosteroid during the last 4 weeks, unless the dose is less or equivalent to 20mg/d prednisone
  • Had tumors or have other tumors, not including non-melanoma skin cancers and cervical carcinoma in situ be treated properly
  • Underwent surgical operation within 28 days before enrollment (exclude lymph node biopsy)
  • Renal disfunction: serum creatinine is more than 1.5 times of upper limit of normal value
  • Hepatic insufficiency: serum total bilirubin is > 1.5 times of upper limit of normal value; AST, ALT is > 2.5 times of upper limit of normal value
  • Known HIV infection or HBV, HCV related active infections; HBsAg is positive; HBcAb is positive and virus copy number is > 1000
  • For patients with other severe medical diseases interfering with their participations of this study(e.g., infections and diabetes not controlled well, gastric ulcer, other lung diseases, active autoimmune diseases), the suitability of participation is judged by investigators
  • Patients participated in other clinical studies and got medical treatments within 30 days prior to enrollment of this trial
  • Other medical and psychological conditions that influence the patients participation or signing of informed consent form

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting
  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bendamustine

Arm Description

Dose of 120 mg/m2/day on Day 1 and Day 2 of each treatment cycle (every 21 days), to a maximum of 8 cycles.

Outcomes

Primary Outcome Measures

Overall response rate (ORR=CR+PR) of bendamustine hydrochloride in patients who are refractory to rituximab therapy.

Secondary Outcome Measures

Safety profile of Bendamustine hydrochloride in this patient population
Progression free survival (PFS)
Overall survival (OS)

Full Information

First Posted
March 29, 2012
Last Updated
August 1, 2012
Sponsor
Shandong Lanjin Pharmaceuticals Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01570049
Brief Title
Safety and Efficacy Study of Bendamustine to Treat Non-Hodgkin Lymphoma
Official Title
A Multicenter, Single Arm Clinical Trial in Patients With Rituximab Refractory B-cell Indolent Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
December 2012 (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 HCl for injection is safe and effective in the treatment of Rituximab refractory or relapsed B-cell indolent lymphoma.
Detailed Description
This is multicenter, open label study to evaluate the safety and efficacy of bendamustine HCl in patients with indolent Non-hodgkin's lymphoma and relapsed after rituximab treatment. This injection will be given through i.v. infusion in >= 60 minutes on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for up to 8 cycles unless progressive disease or unacceptable toxicity take place. Patients will be followed for up to 1 year before evaluating progression free survival (PFS) and overall survival (OS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma by Clinical Course
Keywords
Single arm, Open label, Bendamustine HCl, Non-hodgkin's lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bendamustine
Arm Type
Experimental
Arm Description
Dose of 120 mg/m2/day on Day 1 and Day 2 of each treatment cycle (every 21 days), to a maximum of 8 cycles.
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Intervention Description
for injection
Primary Outcome Measure Information:
Title
Overall response rate (ORR=CR+PR) of bendamustine hydrochloride in patients who are refractory to rituximab therapy.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Safety profile of Bendamustine hydrochloride in this patient population
Time Frame
18 months
Title
Progression free survival (PFS)
Time Frame
18 months
Title
Overall survival (OS)
Time Frame
18 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: 18 to 75 years B-cell indolent lymphoma proved by biopsy, exclude CLL/SLL Rituximab refractory or relapsed lymphoma patients At least 1 measurable tumor with shortest diameter being of > 1.0cm and longest diameter being of > 1.5cm ECOG PS ≤ 2 Anticipated Survival is more than 3 months Hematopoietic function is normal during 14 days before enrollment (unless those abnormities related to lymphoma aggression), including: hemoglobin (Hb) ≥ 8.0g/dl (5.0mmol/L); absolute neutrophil count (ANC) ≥ 1.5X109/L; Platelet count (PLT) ≥ 80X109/L. Acceptable range for abnormities related to lymphoma aggression: Platelet count (PLT) ≥ 50X109/L; White blood cell count (WBC) ≥ 3.5X109/L; Absolute neutrophil count (ANC) ≥ 1.0X109/L Female subjects should not be pregnant and breast-feed, should have contraceptive method during the clinical trial and 12 months thereafter. Subject (or his/her legal representative) agrees to participate the trial and sign the informed consent form Exclusion Criteria: Those who can not tolerate bendamustine treatment according to investigators view Transferred to high grade malignant lymphoma (from low grade follicular lymphoma) 3b grade follicular lymphoma With central nervous system diseases or medical history (e.g., central nervous system lymphoma or lymphoma related meningitis ) With other anticancer treatment during the last 4 weeks Regularly administrated corticosteroid during the last 4 weeks, unless the dose is less or equivalent to 20mg/d prednisone Had tumors or have other tumors, not including non-melanoma skin cancers and cervical carcinoma in situ be treated properly Underwent surgical operation within 28 days before enrollment (exclude lymph node biopsy) Renal disfunction: serum creatinine is more than 1.5 times of upper limit of normal value Hepatic insufficiency: serum total bilirubin is > 1.5 times of upper limit of normal value; AST, ALT is > 2.5 times of upper limit of normal value Known HIV infection or HBV, HCV related active infections; HBsAg is positive; HBcAb is positive and virus copy number is > 1000 For patients with other severe medical diseases interfering with their participations of this study(e.g., infections and diabetes not controlled well, gastric ulcer, other lung diseases, active autoimmune diseases), the suitability of participation is judged by investigators Patients participated in other clinical studies and got medical treatments within 30 days prior to enrollment of this trial Other medical and psychological conditions that influence the patients participation or signing of informed consent form
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huaqing Wang, Master
Phone
+86-022-2334-0123
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huaqing Wang, master
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaqing Wang, Master
Phone
+86-022-2334-0123
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaqing Wang, Master
First Name & Middle Initial & Last Name & Degree
Jian J Yu, Master
Phone
+8615336402751
Email
yujj@lanjin.cn

12. IPD Sharing Statement

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Safety and Efficacy Study of Bendamustine to Treat Non-Hodgkin Lymphoma

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