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FIL‐PTCL13: PHASE IB/II STUDY OF ROMIDEPSIN/CHOEP FOLLOWED BY HIGH‐DOSE CHEMOTHERAPY AND TRANSPLANTATION IN UNTREATED PERIPHERAL T‐CELL LYMPHOMAS. A. Chiappella* | C. Carniti | M. Ceccarelli | M.G. Cabras | A. Re | F. Salvi | A. Santoro | V. Stefoni | S. Pileri | G. Ciccone | P. Corradini Hematology, AOU Città della Salute e della Scienza, On behalf of Fondazione Italiana Linfomi (FIL), Torino, Italy; Division of Hematology and Bone Marrow Transplant, Fondazione IRCCS Istituto Nazionale dei Tumori; Department of Oncology and Hemato‐Oncology, University of Milan, On behalf of Fondazione Italiana Linfomi (FIL), Milan, Italy; Unit of Clinical Epidemiology, CPO, AOU Città della Salute e della Scienza di Torino, On behalf of Fondazione Italiana Linfomi (FIL), Torino, Italy; Hematology, Ospedale “A. Businco” Cagliari, Haematology & Transplant Centre “Wilma Deplano”, On behalf of Fondazione Italiana Linfomi (FIL), Cagliari, Italy; Hematology, Azienda Ospedaliera Spedali Civili di Brescia, On behalf of Fondazione Italiana Linfomi (FIL), Brescia, Italy; Hematology, Azienda Ospedaliera Nazionale SS.Antonio e Biagio e C. Arrigo, On behalf of Fondazione Italiana Linfomi (FIL), Alessandria, Italy; Hematology, Istituto Clinico Humanitas and IRCCS, On behalf of Fondazione Italiana Linfomi (FIL), Rozzano, Italy; Hematology, Istituto L e A Seragnoli, Policlinico S. Orsola‐Malpighi, On behalf of Fondazione Italiana Linfomi (FIL), Bologna, Italy; 9 Institute of Hematology "L. e A. Seràgnoli", Universita degli Studi di Bologna and Haematopathology Unit, Istituto Europeo di Oncologia, On behalf of Fondazione Italiana Linfomi (FIL), Milan, Italy Introduction: Peripheral T‐cell lymphomas (PTCL), with the exception of anaplastic ALK positive subtype, have a poor prognosis. New therapeutic options are needed. Consolidation with autologous stem cell transplantation (autoSCT) can be considered a standard strategy in young patients with chemo‐sensitive disease; however, 25–30% of patients do not become transplant eligible due to primary refractory or early progressive disease. To increase the response rate pre‐ autoSCT, we designed the PTCL13 study (NCT02223208), with CHOEP in combination with romidepsin (Ro‐CHOEP), a non‐cross resistant agent that showed antitumor activity in T‐cell lymphomas and a manageable toxicity profile in combination with chemotherapy, followed by high‐dose chemotherapy plus SCT. Methods: PTCL13 is a phase Ib/II study. Inclusion criteria are stage II– IV patients aged 18–65, with newly diagnosis of peripheral T‐cell lymphomas including PTCL not otherwise specified, angioimmunoblastic, ALK negative anaplastic; no other subtypes are included. The primary endpoint of the phase Ib part of the study is to define the maximum tolerated dose (MTD) of romidepsin in combination to CHOEP chemotherapy; the primary endpoint of the phase II is progression free survival at 18 months. Here, we describe the phase Ib: PTCL13 has 6 CHOEP courses every 21 days combined with romidepsin at the dose of 10 or 12 or 14 mg/ms at days 1 and 8 of each cycle. Responsive patients after will continue the program with one cycle of DHAP (cisplatin, citarabine, desamethasone) followed by stem cell harvest. Patients in complete remission after the 6 Ro‐ CHOEP will proceed to autologous stem cell transplant; patients in partial remission and with an available donor will be considered for alloSCT upfront. Results: The first patient was enrolled in September 2014. As of March 11th 2017, 17 patients were enrolled into the phase Ib part. The first 3 patients were treated with romidepsin at 12 mg/ms; no dose limiting toxicities (DLT) were observed. According to the continual reassessment method, the following 3 patients were treated with romidepsin at 14 mg/ms and one DLT was reported. The following triplets of patients were all treated with romidepsin at 14 mg/ms. All diagnoses were centrally reviewed and tissue samples and blood cells were collected in order to perform additional biological analysis. Conclusions: Enrollment began in September 2014, with the goal of enroll 21–24 patients in the phase Ib part and 110 patients in the phase II part of the trial. The MTD of romidepsin in addition to CHOEP followed by high dose chemotherapy and SCT is not yet defined. We expect to open the enrollment into the phase II part of the study in the next few months.