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

R.L. Piekarz, R. Frye, H.M. Prince, M.H. Kirschbaum, J. Zain, S.L. Allen, E.S. Jaffe, A. Ling, M. Turner, C.J. Peer, W.D. Figg, S.M. Steinberg, S. Smith, David Joske, I. Lewis, L. Hutchins, M. Craig, A.T. Fojo, J.J. Wright, S.E. Bates

    Research output: Contribution to journalArticlepeer-review

    411 Citations (Scopus)

    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 stemcell 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. (Blood. 2011; 117(22): 5827-5834)
    Original languageEnglish
    Pages (from-to)5827-5834
    JournalBlood
    Volume117
    Issue number22
    DOIs
    Publication statusPublished - 2011

    Cite this