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Pixantrone plus rituximab vs gemcitabine plus rituximab in patients with relapsed aggressive B-cell non-Hodgkin lymphoma not eligible for stem cell transplantation: A phase 3, randomized, multicentre trial (PIX306)

British Journal of Haematology Jan 08, 2020

Pettengell R, Długosz-Danecka M, Andorsky D, et al. - By performing this phase 3, randomised, single-blind, multicentre trial, named PIX306, researchers assessed progression-free survival (PFS; primary endpoint) as well as overall survival (OS), complete response (CR) rate, overall response rate (ORR) and safety of pixantrone + rituximab (PIX + R) vs gemcitabine + rituximab (GEM + R) in adult patients suffering from diffuse large B-cell lymphoma or follicular lymphoma grade 3 who relapsed after ≥ 1 rituximab-containing regimen and were not eligible for a stem cell transplant. Randomly, patients were given (1:1) pixantrone 50 mg/m2 or gemcitabine 1000 mg/m2 on days 1, 8 and 15 of a 28-day cycle, combined with rituximab 375 mg/m2 on day 1, for up to six cycles. Patients were thereafter observed for 96 weeks. The primary endpoint was not met. With PIX + R vs GEM + R, the median PFS was 7·3 months vs 6·3 months, median OS was 13·3 months vs 19·6 months, and ORR was 61·9% and 43·9% respectively and CR rate was 35·5% and 21·7%. PIX + R vs GEM + R did not render statistically significantly different incidence of adverse events, including cardiac events.
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