A Phase II study of Bendamustine in Combination With Rituximab as Initial Treatment for Patients With Indolent non-follicular non-Hodgkin's Lymphoma

The purpose of this phase 2 study was to determine the activity and safety of 6 cycles of bendamustine and 8 rituximab (RB) as first-line treatment of adult patients with advanced stage non-follicular indolent non-Hodgkin lymphomas (INFL). The primary endpoint was the complete response rate (CRR) with expected CRR of 75%. Sixty-nine patients were enrolled; median age was 65 years (45-75), 65% were male, 93% of patients had stage IV disease. Complete and overall response rates were 48% (95% IC 35.6-60.2), and 86% (IC 75.0-92.8). The most common grade 3/4 adverse events were neutropenia (43%), thrombocytopenia (7%), anemia (4%); whereas the rate of febrile neutropenia was very low (3%). At a median follow up of 22 months (1-43 months), 2-year progression free survival was 89% (IC: 79-95), and 2-year overall survival was 96% (IC: 87-99). RB combination is active and well tolerated in patients with advanced stage previously untreated INFL.