relapsed or refractory follicular lymphoma
Conditions
Interventions
bendamustine plus rituximab treatment
Sponsors
Kanagawa Clinical Oncology study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1: diagnosed as follicular lymphoma histologically 2: relapse or progression after rituximab containing treatment or anti-body treatment 3: CD20 positive 4: measurable lesion (long axis on CT scan > 1.5cm) 5: age 20-79 years 6: ECOG performance status 0-2 7: adequate organ function as follows; 1)absolute neutrophil count > 1.5 x 10*9/L 2)hemoglobin > 8.0mg/dl 3)platelet count > 100 x 10*9/L 4)AST and ALT levels < 2.5 times the upper limit of the normal range 5)total bilirubin level < 2.0 mg/dL 6)serum creatinine level < 2.0 mg/dL 7)normal ECG 8)SpO2 > 95% 8: life expectancy more than 3 months 9: written informed consent
Exclusion criteria
Exclusion criteria: 1: pregnancy or breast feeding 2: any other malignancy 3: mental illness 4: positive test for HBV surface antigen 5: positive test for HCV anti body 6: positive test for HIV anti body 7: lymphoma cell count > 25 x 10*9/L in peripheral blood 8: post allogenic stem cell transplantation 9: interstitial pneumonia or pulmonary fibrosis 10: central nervous system involvement with lymphoma 11: history of bendamustine treatment 12: inappropriate for rituximab treatment 13: severe hypersensitivity for any drugs 14: inappropriate for entry by physician's decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| complete remission rate, event free survival, progression free survival, toxicity | — |
Countries
Japan
Contacts
Public ContactKen Ohmachi
Tokai University Division of hematology/oncology, department of internal medicine
Outcome results
None listed