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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01570049
Recruitment Status : Unknown
Verified August 2012 by Shandong Lanjin Pharmaceuticals Co.,Ltd.
Recruitment status was:  Recruiting
First Posted : April 4, 2012
Last Update Posted : August 2, 2012
Information provided by (Responsible Party):
Shandong Lanjin Pharmaceuticals Co.,Ltd

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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma by Clinical Course Drug: Bendamustine Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single Arm Clinical Trial in Patients With Rituximab Refractory B-cell Indolent Lymphoma
Study Start Date : April 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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

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

Secondary Outcome Measures :
  1. Safety profile of Bendamustine hydrochloride in this patient population [ Time Frame: 18 months ]
  2. Progression free survival (PFS) [ Time Frame: 18 months ]
  3. Overall survival (OS) [ Time Frame: 18 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01570049

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

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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   
Sponsors and Collaborators
Shandong Lanjin Pharmaceuticals Co.,Ltd
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Principal Investigator: Huaqing Wang, master Tianjin Medical University Cancer Institute and Hospital

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Responsible Party: Shandong Lanjin Pharmaceuticals Co.,Ltd Identifier: NCT01570049     History of Changes
Other Study ID Numbers: RGB-NHL
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012
Keywords provided by Shandong Lanjin Pharmaceuticals Co.,Ltd:
Single arm
Open label
Bendamustine HCl
Non-hodgkin's lymphoma
Additional relevant MeSH terms:
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Bendamustine Hydrochloride
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents