20Jan 2023
Romidepsin-CHOEP followed by high-dose chemotherapy and stem-cell transplantation in untreated Peripheral T-Cell Lymphoma: results of the PTCL13 phase Ib/II study

Romidepsin-CHOEP followed by high-dose chemotherapy and stem-cell transplantation in untreated Peripheral T-Cell Lymphoma: results of the PTCL13 phase Ib/II study

The standard treatment for young patients with untreated PTCLs is based on anthracycline containing-regimens followed by high-dose-chemotherapy and stem-cell-transplantation (HDT + SCT), but only 40% of them can be cured. Romidepsin, a histone-deacetylase inhibitor, showed promising activity in relapsed PTCLs; in the first line, Romidepsin was added with CHOP. A phase Ib/II trial was conducted to define the maximum tolerated dose (MTD) of Ro-CHOEP and to assess the efficacy and safety of 6 Ro-CHOEP as induction before HDT. The study hypothesis was to achieve an 18-month PFS of 70%. Twenty-one patients were enrolled on phase Ib; 7 dose-limiting toxicities were observed, which led to defining the MTD at 14 mg/ms. Eighty-six patients were included in phase II. At a median follow-up of 28 months, the 18-month PFS was 46.2%, and the 18-month overall survival was 73.1%. The overall response after induction was 71%, with 62% CRs. No unexpected toxicities were reported. The primary endpoint was unmet; therefore, the enrollment was stopped at a planned interim analysis. Adding Romidepsin to CHOEP did not improve the PFS of untreated PTCL patients.

  • #oncology

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