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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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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