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

This study is currently recruiting participants.
Verified August 2012 by Shandong Lanjin Pharmaceuticals Co.,Ltd
Sponsor:
Information provided by (Responsible Party):
Shandong Lanjin Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01570049
First received: March 29, 2012
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin Lymphoma by Clinical Course
 Drug: Bendamustine
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Single Arm Clinical Trial in Patients With Rituximab Refractory B-cell Indolent Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources

Further study details as provided by Shandong Lanjin Pharmaceuticals Co.,Ltd:

Primary Outcome Measures:
  • Overall response rate (ORR=CR+PR) of bendamustine hydrochloride in patients who are refractory to rituximab therapy. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety profile of Bendamustine hydrochloride in this patient population [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Progression free survival (PFS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570049

Contacts
Contact: Huaqing Wang, Master +86-022-2334-0123

Locations
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Huaqing Wang, Master     +86-022-2334-0123        
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Huaqing Wang, Master            
Contact: Jian J Yu, Master     +8615336402751     yujj@lanjin.cn    
Sponsors and Collaborators
Shandong Lanjin Pharmaceuticals Co.,Ltd
Investigators
Principal Investigator: Huaqing Wang, master Tianjin Medical University Cancer Institute and Hospital
  More Information

No publications provided

Responsible Party: Shandong Lanjin Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT01570049     History of Changes
Other Study ID Numbers: RGB-NHL
Study First Received: March 29, 2012
Last Updated: August 1, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Shandong Lanjin Pharmaceuticals Co.,Ltd:
Single arm
Open label
Bendamustine HCl
Non-hodgkin's lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Bendamustine
Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013