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A phase 2 study of belinostat (PXD101) in patients with relapsed or refractory acute myeloid leukemia or patients over the age of 60 with newly diagnosed acute myeloid leukemia: a California Cancer Consortium Study

Year: 2013
Type: article
Study design: Clinical Trial
Abstract: We performed a phase II study of belinostat in patients with acute myeloid 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/m(2) 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. Twelve eligible patients with AML were enrolled, of whom six had received at least one prior line of therapy. No CR or PR was seen. Four patients had stable disease for at least five cycles. Grade 3 non-hematological toxicities occurred in four patients. Belinostat as monotherapy has minimal single-agent effect in AML on this dosing schedule.
DOI: 10.3109/10428194.2013.877134
Authors: Mark H. Kirschbaum, Kenneth A. Foon, Paul Frankel, Christopher Ruel, Bernadette Pulone, Joseph M. Tuscano, Edward M. Newman
Institutions: City Of Hope National Medical Center, City of Hope, University of Pittsburgh, UPMC Hillman Cancer Center, UC Davis Comprehensive Cancer Center, University of California, Davis
Language: English
Subfield: Hematology
Field: Medicine
Open Access status: green
Awards: G5367758439, G609966341, G6966134840, G741073515, G772794905, Phase 1 and 2 Molecular and Clinical Pharmacodynamic Trials ETCTN, Cancer Center Support Grant P30
OpenAlex ID: W2106895775
FWCI: 3.087
Cites: 19
Cited by: 71
Related to: 10