relapsed or refractory follicular lymphoma or mantle cell lymphoma
Conditions
Interventions
BRAC therapy Rituximab 375mg/sqm Day 1 Bendamustine 90mg/sqm Day 2,3 Cytarabine 600mg/sqm Day 2,3,4 Filgrastim 300ug/m2/day sc after Day 5
Sponsors
Gifu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with pathologically confirmed follicular lymphoma or mantle cell lymphoma. 2) Patients had received prior treatment of rituximab in combination with chemotherapy or rituximab alone, and were considered no response or relapse after CR or PR. 3) CD20 positive. 4) Patients have measurable lesion that measured >=1.5cm in a single dimension by CT. 5) Patients aged 20-80 years. 6) PS(ECOG) 0-2 7) Patients meet all following standard Absolute neutrophil count >= 1,000/mm3 Hemoglobin >= 8.0 g/dL Platelet count >= 75,000/mm3 AST and ALT < 2.5 times facility criteria. Total bilirubin < 2.5 times facility criteria. Creatinine < 1.5 times facility criteria. Cardiac electro gram: no abnormality required treatment 8) Patients have a life expectancy > 3 months. 9) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients are pregnant or lactating women. Patients (<1 year after menopause without surgical infertility) can not or will not use birth control during the treatment. 2) Patients have active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment. 3) Patients have mental disease or disorder with difficulty in participating in the clinical trial. 4) HIV antibody positive, HBs antigen positive, HCV antibody positive 5) Patients have much tumor cell in peripheral blood (>=25,000/mm3). 6) Patients received allogeneic hematopoietic stem cell transplant. 7) Patients have interstitial lung disease or fibroid lung. 8) Patients have CNS invasion. 9) Patients are inappropriate for rituximab treatment. 10) Patients have severe allergic symptoms. 11) Inadequate for clinical trial entry by the attending physicians.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| overall response rate event free survival progression free survival safty peripheral blood stem cell harvest (transplant case) | — |
Primary
| Measure | Time frame |
|---|---|
| complete response rate | — |
Countries
Japan
Contacts
Public ContactNobuhiko Nakamura
Gifu University Hospital First Department of Internal Medicine
Outcome results
None listed