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

• DOI: 10.1111/bjh.13222
• Publication Date: 2014-11-18T04:31:20Z
• Authors: Francine Foss; Ranjana Advani; Madeleine Duvic; Kenneth B. Hymes; Tanin Intragumtor...; 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
• Keywords: Cutaneous T-cell lymphoma; Peripheral T-cell lymphoma; Refractory (planetary science); Dysgeusia

Summary Belinostat is a pan‐histone deacetylase inhibitor with antitumour and anti‐angiogenic properties. An open label, multicentre study was conducted in patients peripheral T‐cell lymphoma ( PTCL ) or cutaneous CTCL who failed ≥1 prior systemic therapy were treated belinostat (1000 mg/m 2 intravenously ×5 d of 21‐d cycle). The primary endpoint objective response rate ORR ). Patients n = 24) had received median three therapies (range 1–9) 40% stage IV disease. 29) one skin‐directed 0–4) four 1–9); 55% s 25% 14% Treatment‐related adverse events occurred 77% patients; nausea (43%), vomiting (21%), infusion site pain (13%) dizziness (11%) the highest incidence. serious Grade 5 ventricular fibrillation; 4 thrombocytopenia; 3 oedema, apraxia, paralytic ileus pneumonitis; jugular vein thrombosis. monotherapy well tolerated efficacious recurrent/refractory . This trial registered at www.clinicaltrials.gov as NCT 00274651.