A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell Lymphoma
Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
Extranodal NK/T-cell lymphoma is a rare disease entity with aggressive clinical course and
poor prognosis. Currently, there is no treatment option for relapsed or refractory extranodal
NK/T-cell lymphoma. Romidepsin is a histone deacetylase inhibitor which was approved for
cutaneous T-cell lymphoma. A recent phase II study of romidepsin for relapsed/refractory
peripheral T-cell lymphoma reported an overall response rate of 38% (95% confidence interval
24%-53%). The median duration of overall response was 8.9 months. Considering the median
number of previous treatments in these patients was three (range 1-11), romidepsin has single
agent activity against relapsed/refractory T-cell lymphoma. Thus, if the single agent
activity of romidepsin is demonstrated, it could be a therapeutic agent for combination with
salvage treatment.