A Phase 1b/2 Open-label, Randomized Study of 2 Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine: Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus SC Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia Harboring an IDH1 or an IDH2 Mutation, Respectively, Who Are Not Candidates to Receive Intensive Induction Chemotherapy
This Phase 1b/2 study is an open-label, randomized, multicentre trial to evaluate the safety
and efficacy of oral AG-120 + Subcutaneous (SC) azacitidine and oral AG-221 + SC azacitidine
in subjects with newly diagnosed AML with an IDH1 or an IDH2 mutation, respectively. The
study population consists of subjects who are not candidates to receive intensive Inductive
chemotherapy (IC). The study comprises a Phase 1b dose-finding and AG-120 expansion stage
and a Phase 2 randomized stage.
View this trial on ClinicalTrials.gov
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