A randomized phase II study of standard-dose versus high-dose rituximab with BEAM in autologous stem cell transplantation for relapsed aggressive B-cell non-hodgkin lymphomas: long term results.

ABSTRACT: High-dose rituximab (HD-R) combined with carmustine, cytarabine, etoposide and melphalan (BEAM) and autologous stem cell transplant (ASCT) was effective and tolerable in a single-arm prospective study of relapsed aggressive B-cell non-Hodgkin lymphoma (R-NHL). We performed a randomized phase 2 study comparing HD-R versus standard-dose rituximab (SD-R) in R-NHL. Ninety-three patients were randomized to HD-R (1000 mg/m² ) (n = 42) or SD-R (375 mg/m² ) (n = 51) administered on post-transplant days +1 and +8, using a Bayesian adaptive algorithm. The 2 treatment arms were balanced in regards to patient demographic and clinical characteristics. At a median follow-up of 7·92 years, the 5-year disease-free survival (DFS) and overall survival (OS) were 40% and 48%, respectivel

SUBMITTER: Srour SA 

PROVIDER: S-EPMC5672904 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature