Phase II Trial Using Romidepsin after Gemcitabine, Dexamethasone, and Cisplatin Therapy in Elderly Transplant-Ineligible Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma: Study Protocol

Acta Med Okayama. 2019 Oct;73(5):469-474. doi: 10.18926/AMO/57379.

Abstract

Romidepsin is an important therapeutic option for patients with peripheral T-cell lymphoma (PTCL). However, the timing of romidepsin administration remains controversial. Romidepsin was launched in Japan as a consolidation therapy agent after conventional salvage chemotherapy with gemcitabine, dexamethasone, and cisplatin (GDP). GDP therapy will be administered every 3 weeks. If complete response, partial response, or stable disease is confirmed after 2-4 GDP cycles, romidepsin will be administered every 4 weeks. The primary endpoint is a 2-year progression-free survival rate. Patients participating in this study and undergoing treatment can expect results similar to or better than those of conventional therapies.

Keywords: angioimmunoblastic T-cell lymphoma; cisplatin, romidepsin; gemcitabine; peripheral T-cell lymphoma not otherwise specified.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Cisplatin / administration & dosage
  • Clinical Trials, Phase II as Topic
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Depsipeptides / administration & dosage
  • Dexamethasone / administration & dosage
  • Gemcitabine
  • Humans
  • Lymphoma, T-Cell, Peripheral* / drug therapy
  • Lymphoma, T-Cell, Peripheral* / mortality
  • Multicenter Studies as Topic

Substances

  • Cisplatin
  • Deoxycytidine
  • Depsipeptides
  • Dexamethasone
  • Gemcitabine
  • romidepsin