Phase II
PTCL-NOS, ALK-negative
The sample size of the phase II part of the trial was calculated using the PFS as the primary endpoint, according to the two-stage design proposed by Case and Morgan [To demonstrate an absolute improvement from 55% (literature data) to 70% of the 18 months PFS, with an alpha error of 0.05 (one tail), a beta error of 0.10, and assuming 3 years of constant accrual and at least 18 months of follow-up after the enrollment of the last patient, the required total sample size calculated to minimize the expected total study length was 110 (sample size calculated with the Sample Size Tables for Clinical Studies, 3rd edition, by Machin et al. [An exploratory analysis of prognostic factors for PFS and OS was also performed using multivariable Cox models, evaluating histological subgroups (PTCL-NOS, ALK-negative, AITL/THF), age at enrollment, bone marrow involvement, abnormal LDH, Ann Arbor stage, ECOG PS, extranodal involvement.Statistical analyses were performed using Stata, version 14 (StataCorp).