Follicular lymphoma
Conditions
Interventions
The administration of bendamustine hydrochloride is conducted for 28 days as 1 course and infused 90 mg/m2 in day 1 and day 2 (or day 2 and day 3) and discontinued until day 28. Rituximab is adminis
s judgement at the time of the progression. The follow-up CT is photographed at 12th month and 18th month later from the registration date.
Sponsors
Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with first relapse or recurrent follicular lymphoma (grade1-3a), with treatment history of one regimen of chemotherapy or rituximab. (cf. radiation therapy and steroid treatment alone are not regarded as one regimen.) 2) Patients who were diagnosed as pathologically follicular lymphoma in histological diagnosis at onset. 3) Patients who relapsed after complete response (CR) or a recurred after partial response (PR) by immunotherapy, chemotherapy (adrenocortical hormone monotherapy is excluded) or immunochemotherapy. (not matter for the stage of disease) 4) Patients who had 4wks washout period from the former treatment of anticancer drug (2 months washout period in the case of rituximab and ibritumomab tiuxetan). 5) Patients with CD20 positive (initial visit and visit with relapse) 6) Patients with measurable legion (CT minor axis >1.0cm). 7) Both genders at more than 20 years old (age at registration). 8) ECOG Performance Status 0-2 (PS3 is eligible when it is caused by a lymphoma) 9) Patients meet following all criteria within 2 weeks before registration. - Neutrophil >=1,000/mm^3 - Hemoglobin >=8.0g/dL - Platelets >=75,000/mm^3 - AST and ALT <= 3x ULN (eligible when the permeation of lymphoma is regarded as the cause of the liver damage) - Total bilirubin <=2.0mg/dL (eligible when the permeation of lymphoma is regarded as the cause of the liver damage) - Creatinine <=2.0mg/dL - Ejection fraction >=50% - PaO2 >=60mmHg (or SpO2 >=90%) without oxygen inhalation 10) Patients with more than 3 months survival. 11) Patients providing written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients who were determined histologic transformation by biopsy in recurrence (not mandatory). 2) Patients with histological grade 3b. 3) Patients with former treatment of radiation therapy or steroid treatment alone. 4) Pregnant or lactating women. Female patients of childbearing potential, or cannot use or not intent to use an appropriate sterilization within 1year under menopause during a treatment period. 5) Patients with active double cancer (simultaneous double cancer and disease free period of allochronic double cancer is within 5 years. Basal cell cancer, squamous carcinoma, carcinoma in situ judged to be cured by local treatment, and lesion correspond to intramucosal carcinoma are not included in active double cancer.) 6) Patients who are judged to have difficulty in study participation by complication with mental disease or mental manifestation. 7) Patients with HBs antigen positive (cf. patients with HBs antibody and HBc antibody positive are not excluded, but patients who are detected HBV-DNA are excluded.) 8) Patients with HIV antibody positive. 9) Patients with autologous and allogeneic hematopoietic stem cell transplantation 10) Patients with comorbidity of interstitial pneumonia, radiation pneumonia and pulmonary fibrosis checked by a chest CT (within 3 months before registration). 11) Patients with infiltration to CNS. 12) Patients who had received bendamustine or judged to be inadequate of bendamustine administration 13) Patients with severe drug hypersensitivity. 14) Any other patients who are regarded as unsuitable for study enrollment by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression free survival(1-yr PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall response rate (ORR) - Complete response rate (CRR) - 1 year overall survival (1-yr OS) - Event free survival (EFS) - Safety - Relationship between SUV max in standardized PET and response rate/PFS - Relationship between delta SUV and PFS in standardized PET conduct case before treatment | — |
Countries
Japan
Contacts
Public ContactTsutomu Takahashi
Shimane University Hospital Cancer Center
Outcome results
None listed