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A Phase 3, Multicenter, Open Label, Randomized, Non-comparative Two-arm Study of Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Adult Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an Isocitrate Dehydrogenase-1 (IDH1) Mutation (PyramIDH Study)
Conditions
Interventions
Ivosidenib
Azacitidine
Locations
62
United States
Presbyterian / St. Luke'S Medical Center
Denver, Colorado, United States
University of Chicago, Duchossois Center for Advanced Medicine (DCAM)
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
MSKCC
New York, New York, United States
Unc Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Start Date
December 3, 2024
Primary Completion Date
November 1, 2027
Completion Date
December 1, 2028
Last Updated
April 3, 2026
NCT06398457
NCT06886425
NCT07516847
NCT07355478
NCT01660607
NCT05048498
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
CONTACT
+33 1 55 72 60 00scientificinformation@servier.comLead Sponsor
Institut de Recherches Internationales Servier
Collaborators
Data Source & Attribution
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