Introduction
ALK-positive ALCL, ALK-negative ALCL, Peripheral T-cell lymphomas, toxicities, AITL, PTCL, PTCL-NOS, non-Hodgkin lymphomas, PTCLs, anaplastic lymphoma, peripheral T-cell lymphoma, advanced-stage disease
PERIPHERAL T-CELL LYMPHOMA, LYMPHOMA, DISEASE, ANAPLASTIC LARGE CELL LYMPHOMA, REMISSION, NON-HODGKIN LYMPHOMA, ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA
Peripheral T-cell lymphomas (PTCLs) represent 10–15% of all non-Hodgkin lymphomas, are composed by several histological subtypes with different prognoses. With the exception of anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALK-positive ALCL), their outcome is still unsatisfactory [Considering the most frequent entities, such as peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and ALK-negative ALCL, the common first-line treatment for advanced-stage disease is based on cyclophosphamide, doxorubicin, vincristine, prednisone, (CHOP) with or without etoposide (CHOEP), usually followed by consolidation with high dose chemotherapy (HDT) and autologous stem cell transplantation (auto-SCT), in patients aged less than 65 years [The intensification with auto-SCT in patient achieving first remission after induction, has been tested in several phase 2 studies in which ~30% of patients did not reach the transplant phase due to refractory disease [Romidepsin, a histone deacetylase (HDAC) inhibitor, was tested in relapsed or refractory PTCLs, showing a promising activity, with objective responses ranging from 25 to 38%. The safety profile was acceptable, and the most frequent toxicities were hematological [The Lymphoma Study Association conducted a phase Ib-II dose escalation and expansion study evaluating the combination of romidepsin with CHOP in untreated PTCLs. Thirty-seven patients were enrolled and received eight courses of CHOP in association with varying doses of romidepsin (8–10–12 mg/ms) on days 1 and 8; based on a 3 + 3 design, the investigators chose romidepsin at 12 mg/ms as the recommended dose for phase II trials [On these premises, we designed a phase Ib/II trial (PTCL13) in young patients with newly diagnosed PTCL to define the maximum tolerated dose (MTD) and to evaluate the safety, tolerability and efficacy of romidepsin in addition to CHOEP, in a program containing a final consolidation with SCT. Here, we report the final analysis of the phase Ib and the phase II part of PTCL13 trial.