A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis

Srdan Verstovsek, Ruben A Mesa, Jason Gotlib, Richard S Levy, Vikas Gupta, John F DiPersio, John Catalano, Michael Deininger, Carole Miller, Richard Silver, Moshe Talpaz, Elliott F Winton, Jimmie H Harvey, Murat O Arcasoy, Elizabeth Hexner, Roger M Lyons, Ronald Paquette, Azra Raza, Kris Vaddi, Susan Erickson-VittanenIphigenia L Koumenis, William Sun, Victor Sandor, Hagop M Kantarjian

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Abstract

In this doube-blind trial, we randomly assigned patients with intermediate-2 or high-risk myelofibrosis to twice-daily oral ruxolitinib (155 patients) or placebo (154 patients). The primary end point was the proportion of patients with a reduction in spleen volume of 35 or more at 24 weeks, assessed by means of magnetic resonance imaging. Secondary end points included the durability of response, changes in symptom burden (assessed by the total symptom score) and overall survival.
Original languageEnglish
Pages (from-to)799 - 807
Number of pages9
JournalThe New England Journal of Medicine
Volume366
Issue number9
DOIs
Publication statusPublished - 2012

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