Spots Global Cancer Trial Database for Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation
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Trial Identification
Brief Title: Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation
Official Title: A Phase 1, Multicenter, Open-Label, Safety Study of AG-120 or AG-221 in Combination With Induction Therapy and Consolidation Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia With an IDH1 and/or IDH2 Mutation
Study ID: NCT02632708
Study Description
Brief Summary: 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 up to 2 dose levels of AG-120 in participants with an isocitrate dehydrogenase protein 1 (IDH1) mutation and up to 2 dose levels of AG-221 in participants with an isocitrate dehydrogenase protein 2 (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, participants may continue on to maintenance therapy and receive daily treatment with single-agent AG-120 or AG-221 until relapse, development of an unacceptable toxicity, or hematopoietic stem cell transplant (HSCT). The study will end when all participants have discontinued study treatment.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
UCLA Medical Center, Los Angeles, California, United States
University of Colorado, Aurora, Colorado, United States
University of Chicago, Chicago, Illinois, United States
Johns Hopkins University, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Ohio State University, Columbus, Ohio, United States
Medical University of South Carolina - PPDS, Charleston, South Carolina, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Universitatsklinikum Ulm, Ulm, , Germany
VU Medisch Centrum, Amsterdam, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Contact Details
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