A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T‐cell lymphoma. (17th November 2014)

• Record Type: Journal Article
• Authors: Foss, Francine; Advani, Ranjana; Duvic, Madeleine; Hymes, Kenneth B.; Intragumtornchai, Tanin; Lekhakula, Arnuparp; Shpilberg, Ofer; Lerner, Adam; Belt, Robert J.; Jacobsen, Eric D.; Laurent, Guy; Ben‐Yehuda, Dina; Beylot‐Barry, Marie; Hillen, Uwe; Knoblauch, Poul; Bhat, Gajanan; Chawla, Shanta; Allen, Lee F.; Pohlman, Brad
• Is Part Of: British journal of haematology. Volume 168:Number 6(2015:Mar.)
• Page Start: 811
• Page End: 819
• Publication Date: 2014-11-17
• Subjects: Hematology -- Periodicals; Blood -- Diseases -- Periodicals; 616.15
• DOI: 10.1111/bjh.13222
• Languages: English
• ISSNs: 0007-1048

Abstract

<abstract abstract-type="main" id="bjh13222-abs-0001"> <title>Summary</title> <p>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 (1000 mg/m<sup>2</sup> intravenously ×5 d of a 21‐d cycle). The primary endpoint was objective response rate (ORR). Patients with PTCL (<italic>n</italic> = 24) had received a median of three prior systemic therapies (range 1–9) and 40% had stage IV disease. Patients with CTCL (<italic>n</italic> = 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 <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov" xlink:type="simple" xmlns:xlink="http://www.w3.org/1999/xlink">www.clinicaltrials.gov</ext-link> as NCT00274651.</p> </abstract>