Oral Vorinostat (Suberoylanilide Hydroxamic Acid, Saha) In Relapsed Diffuse Large B-Cell Lymphoma (Dlbcl): Final Results Of A Phase Ii Trial

18511 Background: Vorinostat (Zolinza™) is a histone deacetylase inhibitor (HDACI) approved in the US for the treatment of cutaneous manifestations in patients (pts) with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following 2 systemic therapies. Clinical responses with vorinostat have been reported in other lymphoma subtypes. Methods: Open-label, single-arm, nonrandomized Phase II trial of oral vorinostat 300 mg bid (initially 14 d/3 wks; amended to 3 d/wk) until disease progression or intolerable toxicity. Eligibility: measurable, relapsed/refractory DLBCL; = 2 prior systemic therapies; adequate hematologic, hepatic and renal function. Pts who had prior HDACI treatment, allogeneic transplant, or had failed u003e 3 prior therapies were excluded. Primary endpoint: objective response rate (ORR) measured by CT/PET. Secondary endpoints: assessment of response duration (DOR), time to progression (TTP), time to response (TTR) and safety. Results: Eighteen pts (median age, ...