Phase Ib
toxicity
ADVERSE EVENT, SECONDARY
The primary objective of phase Ib was to define the MTD of romidepsin in addition to CHOEP; the secondary objective was to assess the feasibility of Ro-CHOEP in a program including high-dose chemotherapy and transplantation.The primary endpoint was to determine the incidence of dose-limiting toxicity (DLT) of romidepsin, considering as maximum dose the one causing any grade ≥3 non-hematologic toxicity or a delay >15 days of planned cycle, during the first two cycles according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009).Secondary endpoints were to evaluate the proportion of patients reaching SCT and the overall response rate (ORR) at the end of the induction with Ro-CHOEP.