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

Shandong Lanjin Pharmaceuticals

Status and phase

Unknown

Phase 3

Conditions

Non-Hodgkin Lymphoma by Clinical Course

Treatments

Drug: Bendamustine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01570049

RGB-NHL

Details and patient eligibility

About

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.

Full 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).

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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