Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma

Richard L. Piekarz, Robin Frye, H. Miles Prince, Mark H. Kirschbaum, Jasmine Zain, Steven L. Allen, Elaine S. Jaffe, Alexander Ling, Maria Turner, Cody J. Peer, William D. Figg, Seth M. Steinberg, Sonali Smith, David Joske, Ian Lewis, Laura Hutchins, Michael Craig, A. Tito Fojo, John J. Wright, Susan E. Bates

Research output: Contribution to journalArticlepeer-review

417 Scopus citations

Abstract

Romidepsin (depsipeptide or FK228) is a histone deacetylase inhibitor, one of a new class of agents active in T-cell lymphoma. A phase 2 trial was conducted in cutaneous (CTCL) and peripheral (PTCL) T-cell lymphoma. Major and durable responses in CTCL supported the approval of romidepsin for CTCL. Forty-seven patients with PTCL of various subtypes including PTCL NOS, angioimmunoblastic, ALK-negative anaplastic large cell lymphoma, and enteropathy-associated T-cell lymphoma were enrolled. All patients had received prior therapy with a median of 3 previous treatments (range 1-11); 18 (38%) had undergone stem-cell transplant. All patients were evaluated for toxicity; 2 patients discovered to be ineligible were excluded from response assessment. Common toxicities were nausea, fatigue, and transient thrombocytopenia and granulocytopenia. Complete responses were observed in 8 and partial responses in 9 of 45 patients, for an overall response rate of 38% (95% confidence interval 24%-53%). The median duration of overall response was 8.9 months (range 2-74). Responses were observed in various subtypes, with 6 responses among the 18 patients with prior stem-cell transplant. The histone deacetylase inhibitor romidepsin has single agent clinical activity associated with durable responses in patients with relapsed PTCL. This study has been registered at clinical-trials. gov as NCT00007345.

Original languageEnglish
Pages (from-to)5827-5834
Number of pages8
JournalBlood
Volume117
Issue number22
DOIs
StatePublished - 2 Jun 2011
Externally publishedYes

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