A randomized phase2 study of bendamustine plus Rituximab for relapsing or refractory follicular lymphoma comparing 90 mg/sqm BR vs. 120 mg/sqm BR.
- Conditions
- Follicular lymphoma
- Registration Number
- JPRN-UMIN000009243
- Lead Sponsor
- Juntendo, Yamanashi Clinical Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 36
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CR
- Secondary Outcome Measures
Name Time Method