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 - BRB Study

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.