A randomized phase2 study of bendamustine monotherapy for relapsing or refractory low-grade B-cell non-Hodgkin's lymphoma or mantle cell lymphoma comparing administration schedule.
- Conditions
- ow-grade B-cell non-Hodgkin's lymphoma or mantle cell lymphoma
- Registration Number
- JPRN-UMIN000008702
- Lead Sponsor
- Shimousa blood study group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 54
Not provided
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.HBs antigen positive. 5.HIV antibody-positive. 6.With a lot of tumor cells in peripheral blood (more than 25,000/µL). 7.having received hematopoietic stem cell transplantation. 8.With interstitial pneumonia, radiation pneumonia, or pulmonary fibrosis on the chest CT scan (within 3-months before registration). 9.With CNS infiltration. 10.Have experience with bendamustine treatment or diagnosed unsuitable for bendamustine treatment. 11.With severe drug hypersensitivity. 12.Judged as inappropriate for this study by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Completion rate of 6 cycles
- Secondary Outcome Measures
Name Time Method Overall response rate;ORR Complete response rate;CR Event-free survival;EFS Progression-free survival;PFS Safety(frequency and severity of adverse events and adverse drug reactions) Immune-function monitoring(CD4 lymphocyte count, CD4 / 8 ratios )