A Phase 2 Study of Belinostat (PXD101) in Patients with Relapsed or Refractory Acute Myloid Leukemia or Patients Over 60 with Newly-Diagnosed Acute Myloid Leukemia: A California Cancer Consortium Study

• Published in: Leukemia & lymphoma Vol. 55; no. 10; pp. 2301 - 2304
• Main Authors: Kirschbaum, Mark H., Foon, Kenneth A., Frankel, Paul, Ruel, Christopher, Pulone, Bernadette, Tuscano, Joseph M., Newman, Edward M.
• Format: Journal Article
• Language: English
• Published: 24.02.2014
• ISSN: 1042-8194; 1029-2403
• DOI: 10.3109/10428194.2013.877134

We performed a phase II study of belinostat in patients with acute myloid leukemia (AML). In this open label phase II study (NCT00357032), patients with relapsed/refractory AML, or newly diagnosed patients with AML over the age of 60 were eligible. Belinostat was administered intravenously (IV) at a dose of 1000 mg/m2 daily on days 1–5 of a 21-day cycle until progression or unacceptable toxicity. The primary endpoint was complete response (CR) rate, with secondary endpoints of overall response rate [CR+partial response (PR)], time to treatment failure (TTF), overall survival and safety. 12 eligible patients with AML were enrolled, of whom 6 had received at least one prior line of therapy. No CR or PR were seen. Four patients had stable disease for at least 5 cycles. Grade 3 non-hematological toxicities occurred in 4 patients. Belinostat as monotherapy has minimal single agent effect in AML on this dosing schedule.