Phase II
toxicities, death
LYMPHOMA, DISEASE PROGRESSION, SECONDARY
The primary objective of phase II was to evaluate the activity in term of PFS and to confirm the safety of Ro-CHOEP.The primary endpoint was the PFS, calculated from the date of enrollment to the date of disease progression, relapse, or death from any cause.The secondary endpoints included the ORR and the CR, after Ro-CHOEP and after HDT and transplantation, the OS (defined as the time between the date of enrollment and the date of death from any cause in the ITT population enrolled in the study). Safety secondary endpoints included toxicities during the induction and in all treatments, recorded and classified according to the definitions of NCI CTCAE, v4.0. The treatment-related mortality is defined as any death that was not attributable to the lymphoma.