Romidepsin in relapsed/refractory T-cell lymphomas: Italian experience and results of a named patient program

Leuk Lymphoma. 2016 Oct;57(10):2370-4. doi: 10.3109/10428194.2015.1137292. Epub 2016 Feb 17.


Clinical trial results indicate that romidepsin, a histone deacetylase inhibitor, is a promising treatment in relapsed/refractory T-cell lymphomas (TCLs). This retrospective multicenter study was conducted in patients with relapsed/refractory TCL treated with romidepsin monotherapy through a Named Patient Program (NPP) in Italy. Principal endpoints were overall response rate (ORR), safety, and overall survival (OS). The ORR in 33 evaluable patients was 24.2% with an ORR in the cutaneous TCL of 35.7%. Global OS was 39.3% at 30 months. There were not any specific differences on hematological and extrahematological adverse events. Data from patients treated with romidepsin outside a controlled clinical trial give additional information about the clinical use, efficacy, and toxicity of the drug given to relapsed or refractory TCL patients in a real life context as TCLs are rare diseases and more information is needed. These findings suggest that romidepsin is effective and safe for heavily pretreated TCL patients.

Keywords: Real life; T-cell lymphoma; refractory; relapsed; romidepsin.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Antibiotics, Antineoplastic / administration & dosage
  • Antibiotics, Antineoplastic / adverse effects
  • Antibiotics, Antineoplastic / therapeutic use*
  • Depsipeptides / administration & dosage
  • Depsipeptides / adverse effects
  • Depsipeptides / therapeutic use*
  • Drug Resistance, Neoplasm
  • Female
  • Humans
  • Lymphoma, T-Cell / drug therapy*
  • Lymphoma, T-Cell / mortality
  • Lymphoma, T-Cell / pathology*
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Recurrence
  • Retreatment
  • Retrospective Studies
  • Survival Analysis
  • Treatment Outcome


  • Antibiotics, Antineoplastic
  • Depsipeptides
  • romidepsin