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

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.

• Authors: 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
• Journal: Blood (Blood) Vol. 117 Issue 22 Pg. 5827-34 (Jun 02 2011) ISSN: 1528-0020 [Electronic] United States
• PMID: 21355097 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Intramural, Research Support, Non-U.S. Gov't)

Chemical References

• Antibiotics, Antineoplastic
• Depsipeptides
• romidepsin

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibiotics, Antineoplastic (pharmacokinetics, therapeutic use)
• Depsipeptides (pharmacokinetics, therapeutic use)
• Disease Progression
• Female
• Humans
• Lymphoma, Large-Cell, Anaplastic (drug therapy)
• Lymphoma, T-Cell, Cutaneous (drug therapy)
• Lymphoma, T-Cell, Peripheral (drug therapy)
• Male
• Middle Aged
• Remission Induction
• Skin Neoplasms (drug therapy)
• Survival Rate
• Tissue Distribution
• Treatment Outcome