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 | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02632708

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
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

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 patients with an IDH1 mutation and 2 dose levels of AG-221 in patients 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, patients may continue on maintenance therapy and receive daily treatment of AG-120 or AG-221 for up to 1 year from Day 1 of the first induction cycle, or until relapse, development of an unacceptable toxicity, or hematopoietic stem cell transplant (HSCT).

Status: 
Recruiting
Study Date: 
Tue, 12/01/2015 to Thu, 03/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Drug: AG-120 Drug: AG-221 Drug: cytarabine Drug: daunorubicin Drug: idarubicin Drug: mitoxantrone Drug: etoposide