Defining Prior Therapy in Myelodysplastic Syndromes and Criteria for Relapsed and Refractory Disease: Implications for Clinical Trial Design and Enrollment

Blood. 2009 Sept 24;114(13):2575-2580, MA Sekeres, DP Steensma

Abstract

Abstract

The recent approval of 3 drugs for the treatment of myelodysplastic syndromes (MDSs) has resulted in a revolution in therapeutic options that was absent a decade ago. At the same time, the changing MDS environment is raising new challenges in clinical trial design and defining new indications for MDS drugs. Many current trials still rely on IPSS-based enrollment criteria, despite the well-recognized limitations of the IPSS. Clinical trialists designing studies struggle with several important trial...

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