Bendamustine/Mitoxantrone/Rituximab (BMR): A Very Effective and Well Tolerated Immuno-Chemotherapy for Relapsed and Refractory Indolent Lymphomas - Results of a Multicentre Phase-II-Study of the German Low Grade Lymphoma Study Group (GLSG).

In a previous phase-I-study we could demonstrate that the combination of the two chemotherapeutic agents bendamustine and mitoxantrone in combination with the lymphocyte-specific antibody rituximab (BMR) is a highly effective regimen in the treatment of relapsed or refractory indolent lymphomas and CLL (Leukemia and Lymphoma 2002, 43(2):327–331). Based on these data we have conducted a multicenter phase-II-study to further evaluate the efficacy and toxicity of BMR. BMR treatment schedule consisted of Bendamustine 90mg/m² (days 1+2), Mitoxantrone 10mg/m² (day 1) and Rituximab 375mg/m² (day 8). Treatment was repeated on day 29 for a total of 4 cycles. Between 04/03 and 07/04, 39 patients (pts) with symptomatic stage III/IV indolent lymphomas were treated with BMR (18 follicular, 11 mantle cell, 3 marginal zone, 6 immunocytoma and 1 patient with hairy cell leukemia). All pts were treated on an outpatient base. Median age was 67 years (40 – 83) and their performance score ranged from 0–2. Median number of previous treatment regimens was 1 (1–8). 16 pts (41%) had rituximab pretreatment. Currently, 25 pts are evaluable: A reversible grade 3/4 hematotoxicity occurred in 19 pts (76%), no treatment related death was reported. The overall response rate was 92% with 36% complete remissions and 56% partial remissions. Updated results on progression-free and overall survival rates will be presented. We conclude that BMR is a very effective and well tolerated immuno-chemotherapy for relapsed or refractory indolent lymphomas.