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Background  Cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP)/CHOP-like chemotherapy is widely used in peripheral T cell lymphoma (PTCL). Here we conducted a phase 2, multicenter, randomized, controlled trial, comparing the efficacy and safety of CEOP/IVE/GDP alternating regimen with CEOP in newly diagnosed PTCL.    Methods  PTCL patients, except for anaplastic large cell lymphoma-anaplastic lymphoma kinase positive, were 1:1 randomly assigned to receive CEOP/IVE/GDP (CEOP, cyclophosphamide 750 mg/m 2 , epirubicin 70 mg/m 2 , vincristine 1.4 mg/m 2  [maximum 2 mg] on day 1, and prednisone 60 mg/m 2  [maximum 100 mg] on days 1–5 every 21 days, at the first and fourth cycle; IVE, ifosfamide 2000 mg/m 2  on days 1–3, epirubicin 70 mg/m 2  on day 1, and etoposide 100 mg/m 2  on days 1–3 every 21 days, at the second and fifth cycle; and GDP, gemcitabine 1000 mg/m 2  on days 1 and 8, cisplatin 25 mg/m 2  on days 1–3, and dexamethasone 40 mg on days 1–4 every 21 days, at the third and sixth cycle) and CEOP (every 21 days for 6 cycles). Analysis of efficacy and safety was of the intent-to-treatment population. The primary endpoint was a complete response rate at the end of treatment. Meanwhile, whole exome sequencing and targeted sequencing were performed in 62 patients with available tumor samples to explore prognostic biomarkers in this cohort as an exploratory post hoc analysis.    Results  Among 106 patients, 53 each were enrolled to CEOP/IVE/GDP and CEOP. With 51 evaluable patients each in two groups, a complete response rate of the CEOP/IVE/GDP group was similar to that of the CEOP group (37.3% vs. 31.4%,  p  = 0.532). There was no difference in median progression-free survival (PFS; 15.4 months vs. 9.2 months,  p  = 0.122) or overall survival (OS; 24.3 months vs. 21.9 months,  p  = 0.178). Grade 3–4 hematological and non-hematological adverse events were comparable. Histone modification genes were most frequently mutated (25/62, 40.3%), namely  KMT2D ,  KMT2A ,  SETD2 ,  EP300 , and  CREBBP . Multivariate analysis indicated that  CREBBP  and  IDH2  mutations were independent factors predicting poor PFS and OS (all  p  < 0.001), while  KMT2D  predicting poor PFS ( p  = 0.002).    Conclusions  CEOP/IVE/GDP alternating regimen showed no remission or survival advantage to standard chemotherapy. Future clinical trials should aim to develop alternative regimen targeting disease biology as demonstrated by recurrent mutations in epigenetic factors.    Trial registration  The study was registered on ClinicalTrial.gov (NCT02533700) on August 27, 2015.supplementary material   Supplementary information  accompanies this paper at 10.1186/s13073-020-00739-0.

genome medicine

CEOP/IVE/GDP alternating regimen compared with CEOP as the first-line therapy for newly diagnosed patients with peripheral T cell lymphoma: results from a phase 2, multicenter, randomized, controlled clinical trial