A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma

Francine Foss, Ranjana Advani, Madeleine Duvic, Kenneth B. Hymes, Tanin Intragumtornchai, Arnuparp Lekhakula, Ofer Shpilberg, Adam Lerner, Robert J. Belt, Eric D. Jacobsen, Guy Laurent, Dina Ben-Yehuda, Marie Beylot-Barry, Uwe Hillen, Poul Knoblauch, Gajanan Bhat, Shanta Chawla, Lee F. Allen, Brad Pohlman

Research output: Contribution to journalArticlepeer-review

135 Scopus citations

Abstract

Belinostat is a pan-histone deacetylase inhibitor with antitumour and anti-angiogenic properties. An open label, multicentre study was conducted in patients with peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) who failed ≥1 prior systemic therapy and were treated with belinostat (1000mg/m2 intravenously ×5d of a 21-d cycle). The primary endpoint was objective response rate (ORR). Patients with PTCL (n=24) had received a median of three prior systemic therapies (range 1-9) and 40% had stage IV disease. Patients with CTCL (n=29) had received a median of one prior skin-directed therapy (range 0-4) and four prior systemic therapies (range 1-9); 55% had stage IV disease. The ORRs were 25% (PTCL) and 14% (CTCL). Treatment-related adverse events occurred in 77% of patients; nausea (43%), vomiting (21%), infusion site pain (13%) and dizziness (11%) had the highest incidence. Treatment-related serious adverse events were Grade 5 ventricular fibrillation; Grade 4 thrombocytopenia; Grade 3 peripheral oedema, apraxia, paralytic ileus and pneumonitis; and Grade 2 jugular vein thrombosis. Belinostat monotherapy was well tolerated and efficacious in patients with recurrent/refractory PTCL and CTCL. This trial was registered at www.clinicaltrials.gov as NCT00274651.

Original languageEnglish
Pages (from-to)811-819
Number of pages9
JournalBritish Journal of Haematology
Volume168
Issue number6
DOIs
StatePublished - 1 Mar 2015
Externally publishedYes

Keywords

  • Belinostat
  • Histone deacetylase inhibitors
  • Mycosis fungoides
  • Peripheral T cell Lymphoma
  • T cell lymphoma

ASJC Scopus subject areas

  • Hematology

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