Multinational phase 3 trial of oral azacitidine versus standard therapy for relapsed or refractory follicular helper T-cell lymphoma

The phase 3 ORACLE trial, at university hospitals in five European countries and Japan, compared oral azacitidine versus investigator’s choice of therapy (ICT: gemictabine, bendamustine, or romidepsin) for relapsed or refractory follicular helper T-cell lymphoma (R/R TFHL). The median progression-free survival was 5.6 months with azacitidine versus 2.8 months with ICT (HR 0.63; p=0.042). Grade 3 or 4 adverse events were seen in 76% of patients in the azacitidine group and 98% of patients in the ICT group. There were two treatment related deaths in the azacitidine group (4.7%) and three in the ICT group (6.8%). The authors conclude that azacitidine could add to the treatment options for R/R TFHL.