Pooled analyses of two international, multicenter clinical studies of romidepsin in 167 patients with cutaneous T-cell lymphoma (CTCL).

@article{Demierre2009PooledAO,
  title={Pooled analyses of two international, multicenter clinical studies of romidepsin in 167 patients with cutaneous T-cell lymphoma (CTCL).},
  author={Marie France Demierre and Sean Whittaker and Yeul Hong Kim and Ellen Kim and Richard L. Piekarz and Mark Prince and Jean Brashear Nichols and John P Balser and Archibald Prentice and Susan Bates},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  year={2009},
  volume={27 15_suppl},
  pages={8546}
}
8546 Background: Romidepsin is a novel pan-HDAC inhibitor with demonstrated single-agent activity in 2 open-label clinical studies of 167 patients (pts) with CTCL [mycosis fungoides or Sézary Syndrome (SS)]. Data for these 2 studies were pooled for more accurate estimates of endpoints and investigation of subpopulations. METHODS GPI-04-0001 (pivotal study) enrolled 96 pts with confirmed CTCL who had recieved ≥1 prior systemic therapy. NCI 1312 (supportive study) enrolled 71 pts with CTCL. Pts… CONTINUE READING