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

August 1, 2012 updated by: Shandong Lanjin Pharmaceuticals Co.,Ltd

A Multicenter, Single Arm Clinical Trial in Patients With Rituximab Refractory B-cell Indolent Lymphoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer institute and hospital
        • Contact:
          • Huaqing Wang, Master
        • Contact:
          • Jian J Yu, Master
          • Phone Number: +8615336402751
          • Email: yujj@lanjin.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bendamustine
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.
Drug: Bendamustine
for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate (ORR=CR+PR) of bendamustine hydrochloride in patients who are refractory to rituximab therapy.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety profile of Bendamustine hydrochloride in this patient population
Time Frame: 18 months
18 months
Progression free survival (PFS)
Time Frame: 18 months
18 months
Overall survival (OS)
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Lanjin Pharmaceuticals Co.,Ltd

Investigators

  • Principal Investigator: Huaqing Wang, master, Tianjin Medical University Cancer institute and hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGB-NHL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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