Know Cancer

forgot password

A Multicenter, Single Arm Clinical Trial in Patients With Rituximab Refractory B-cell Indolent Lymphoma

Phase 3
18 Years
75 Years
Open (Enrolling)
Non-Hodgkin Lymphoma by Clinical Course

Thank you

Trial Information

A Multicenter, Single Arm Clinical Trial in Patients With Rituximab Refractory B-cell Indolent Lymphoma

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).

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

- Renal disfunction: serum creatinine is more than 1.5 times of upper limit of normal

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (ORR=CR+PR) of bendamustine hydrochloride in patients who are refractory to rituximab therapy.

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Huaqing Wang, master

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tianjin Medical University Cancer Institute and Hospital


China: Food and Drug Administration

Study ID:




Start Date:

April 2010

Completion Date:

December 2012

Related Keywords:

  • Non-Hodgkin Lymphoma by Clinical Course
  • Single arm
  • Open label
  • Bendamustine HCl
  • Non-hodgkin's lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin