Clinical PhII Study: Investigation for safety and efficacy of bendamustine and rituximab, B-R combination therapy for the patients of recurrent and/or refractory low-grade B cell lymphoma or mantle cell lymphoma previously treated with one or two regimen including rituximab
- Conditions
- Relapsed and/or refractory low-grade B cell non-Hodgkin lymphoma
- Registration Number
- JPRN-UMIN000005613
- Lead Sponsor
- Keio BRB Study group
- Brief Summary
Fifty-three patients were enrolled in this study and analyzed. The diagnosis included follicular lymphoma (FL) (77 %), mucosa-associated lymphoid tissue lymphoma (13 %) and others (10 %). Forty-seven (90 %) patients completed four cycles of treatment as per schedule. Best overall response rate (ORR) and complete response rate (CRR) was 94 and 71 %, respectively (for FL, ORR 95 % and CRR 80 %). The treatment was well tolerated and the primary toxicity was myelosuppression; the incidence of grade 3/4 leukopenia and neutropenia were 42 and 40 %, respectively. There were no grade 5 toxicities. For the evaluation of late toxicity, especially infection, longer follow-up of this cohort is needed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Not provided
1. Pregnancy, brest-feedings, or pts who would be pregnant 2. Active double cancer 3. Psychotics judged could not be difficutlt to attend 4. Severe complication and/or infection 5. Liver cirrhosis 6. Interstitial pneumonitis 7. Tumor cells in PB are 25000/uL or more 8. CNS invasion 9. Past history of bendamustine administration 10.Inappropriate to administer rituximab 11.Sever hypersensitity on any agents 12.Judged to be inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (best response)
- Secondary Outcome Measures
Name Time Method Adverse events Complete response rate TTP OS HT rate SPM rate