Last updated on April 2018

Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia With an IDH1 and/or IDH2 Mutation

Brief description of study

The purpose of this Phase I, multicenter, clinical trial is to evaluate the safety of AG-120 and AG-221 when given in combination with standard AML induction and consolidation therapy. The study plans to evaluate 1 dose level of AG-120 in subjects with an IDH1 mutation and 1 dose level (and 2 dose schedules) of AG-221 in subjects with an IDH2 mutation. AG-120 or AG-221 will be administered with 2 types of AML induction therapies (cytarabine with either daunorubicin or idarubicin) and 2 types of AML consolidation therapies (mitoxantrone with etoposide [ME] or cytarabine). After consolidation therapy, subjects may continue on to maintenance therapy and receive daily treatment of AG-120 or AG-221 until the end of study or until relapse, development of an unacceptable toxicity, or hematopoietic stem cell transplant (HSCT). End of study is defined as 2 years from the time the last subject enrolls, or sooner, if all subjects have come off study (or withdrew consent) prior to 2 years after the last subject has enrolled.

Clinical Study Identifier: NCT02632708

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