This is a phase 2 study of selinexor for MDS patients (with up to 30% blasts) and CMML who have received prior decitabine or 5-azacytidine. The primary endpoint is to determine the response rate of this novel drug in patients who have refractory or relapsed disease after receiving either decitabine or 5-azacytidine.
Secondary Objectives of the study are to determine if selinexor improves the survival of people with MDS and CMML after receiving 5-azacytidine and CMML. Additional secondary endpoints include an assessment of response duration and tolerability of selinexor, and to perform research studies on blood and bone marrow samples to better understand the mechanism of selinexor in MDS and CMML.
ClinicalTrials.gov Identifier:
NCT02228525