Spots Global Cancer Trial Database for A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy
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Trial Identification
Brief Title: A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy
Official Title: 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
Study ID: NCT02677922
Conditions
Study Description
Brief Summary: The purpose of this study are 1. to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and, 2. to investigate the safety, tolerability, and efficacy of the combinations of AG-120 with azacitidine and AG-221 with azacitidine versus with azacitidine alone in participants with acute myeloid leukemia (AML) with the isocitrate dehydrogenase (IDH) enzyme isoforms 1 or 2 mutations, respectively.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 105, Duarte, California, United States
Local Institution - 107, New Haven, Connecticut, United States
Local Institution - 108, Chicago, Illinois, United States
Local Institution - 103, Chicago, Illinois, United States
Local Institution - 102, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Local Institution - 902, Boston, Massachusetts, United States
Local Institution - 106, New York, New York, United States
Local Institution - 110, Dallas, Texas, United States
Local Institution - 178, Adelaide, South Australia, Australia
Local Institution - 175, Melbourne, , Australia
Local Institution - 177, Perth, , Australia
Local Institution - UNK-121, Yvoir, , Belgium
Local Institution - 125, Toronto, Ontario, Canada
Local Institution - 205, Lille, , France
Local Institution - 206, Marseille Cedex 9, , France
Local Institution - 200, Paris Cedex 10, , France
Local Institution - 204, Pessac, , France
Local Institution - 202, Pierre Benite, , France
Local Institution - 203, Toulouse, , France
Local Institution - 201, Villejuif CEDEX, , France
Local Institution - 227, Berlin, , Germany
Local Institution - 230, Dresden, , Germany
Local Institution - 225, Ulm, , Germany
Local Institution - 253, Bologna, Emilia-Romagna, , Italy
Local Institution - 252, Firenze, , Italy
Local Institution - 256, Genova, , Italy
Local Institution - 251, Orbassano, , Italy
Local Institution - 254, Padova, , Italy
Local Institution - 250, Pesaro, , Italy
Local Institution - 255, Roma, , Italy
Local Institution - 351, Seoul, , Korea, Republic of
Local Institution - 350, Seoul, , Korea, Republic of
Local Institution - 277, Utrecht, , Netherlands
Local Institution - 327, Lisboa, , Portugal
Local Institution - 379, Barcelona, , Spain
Local Institution - 375, Barcelona, , Spain
Local Institution - 376, Caceres, , Spain
Local Institution - 378, Madrid, , Spain
Local Institution - 381, Madrid, , Spain
Local Institution - 380, Malaga, , Spain
Local Institution - 377, Valencia, , Spain
Local Institution - UNK-52, Göteborg, , Sweden
Local Institution - 403, Basel, , Switzerland
Local Institution - 401, Zurich, , Switzerland
Local Institution - 429, Birmingham, , United Kingdom
Local Institution - 427, Headington, , United Kingdom
Local Institution - 428, London, , United Kingdom
Local Institution - 430, Sutton (Surrey), , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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