Follicular lymphoma
Conditions
Interventions
Standerd dose bendamusutine 90mg/sqm day1-2 rituximab 375mg/sqm day1 1 cycle of 28days
Standerd dose bendamusutine 120mg/sqm day1-2 rituximab 375mg/sqm day1 1 cycle of 28days
Sponsors
Juntendo, Yamanashi Clinical Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Pathological diagnosis of follicular lymphoma on the basis of biopsy. 2 Patients who did not enter in partial remission (PR) by chemotherapy(except single adrenocortical hormones), or relapsed after attaining complete remission (CR) or PR.Regardless of the number and the type of ex-chemotherapy. 3 CD20 positive. 4 With measurable lesion (>1.5cm on the CT scan) 5 Age 20 to 80 at the time of registration. 6 ECOG Performance Status 0-2. 7 Patients who meet all the following standards. Neutrophil count : More than 1,000/mm3 Hemoglobin :>= 8.0 g/dL blood platelet count :>=75,000/mm3 AST, ALT, T-BIL in the blood: less than 2.5 times normal level Electrocardiogram :normal or not required to be treated. 8 Expected at least 3 months survival. 9 Agree to participate in this study with written consent.
Exclusion criteria
Exclusion criteria: 1 Pregnant women or nursing mothers. In postmenopausal women within a year. Women and men who cannot prevent pregnancy or do not have intension to prevent during the treatment period 2 With active double cancer (synchronous double cancer or metachronous double cancer which have 5-years of disease-free, except for basal cell carcinoma, squamous cell carcinoma, carcinoma in situ which goes into remission by topical treatment, or lesion part equivalent to intramucosal carcinoma.) 3 With mental disease or neurologic manifestation considered to be difficult to participate in this study. 4 HBV-DNA positive. HIV antibody-positive. HCV antibody-positive. 5 Patients have much tumor cell in peripheral blood (>=25,000/microL). 6 Having received hematopoietic stem cell transplantation. 7 With interstitial pneumonia, radiation pneumonia, or pulmonary fibrosis on the chest CT scan (within 3-months before registration). 8 With CNS infiltration. 9 Have experience with bendamustine treatment or diagnosed unsuitable for bendamustine treatment. 10 With severe drug hypersensitivity. 11 Judged as inappropriate for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR | — |
Countries
Japan
Outcome results
None listed