Safety and Efficacy Study of Bendamustine to Treat Non-Hodgkin Lymphoma
Conditions
Non-Hodgkin Lymphoma by Clinical Course
Conditions: official terms
Lymphoma - Lymphoma, Non-Hodgkin
Conditions: Keywords
Single arm, Open label, Bendamustine HCl, Non-hodgkin's lymphoma
Study Type
Interventional
Study Phase
Phase 3
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Bendamustine
Type: Drug
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
Locations
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China
Status: Recruiting
Contact: Huaqing Wang, Master - +86-022-2334-0123
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China
Status: Recruiting
Contact: Huaqing Wang, Master
Start Date
April 2010
Completion Date
December 2012
Sponsors
Shandong Lanjin Pharmaceuticals Co.,Ltd
Source
Shandong Lanjin Pharmaceuticals Co.,Ltd
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page