Clinical trial NCT01570049: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-Hodgkin Lymphoma by Clinical Course
Keywords: Single arm
Open label
Bendamustine HCl
Non-hodgkin's lymphoma
Lead sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2012-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Overall response rate (ORR=CR+PR) of bendamustine hydrochloride in patients who are refractory to rituximab therapy.
timeFrame: 18 months
Secondary outcomes:
measure: Safety profile of Bendamustine hydrochloride in this patient population
timeFrame: 18 months
measure: Progression free survival (PFS)
timeFrame: 18 months
measure: Overall survival (OS)
timeFrame: 18 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Huaqing Wang, master
role: PRINCIPAL_INVESTIGATOR
References: