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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
Sponsor: Celgene
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2016-06-03
Completion Date
2026-09-30
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
AG-120
Specified dose on specified days
Azacitidine
Specified dose on specified days
AG-221
Specified dose on specified days
Locations (49)
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, France
Local Institution - 200
Paris, France
Local Institution - 204
Pessac, France
Local Institution - 202
Pierre-Bénite, France
Local Institution - 203
Toulouse, France
Local Institution - 201
Villejuif, 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
Florence, 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 - 277
Utrecht, Netherlands
Local Institution - 327
Lisbon, Portugal
Local Institution - 351
Seoul, South Korea
Local Institution - 350
Seoul, South Korea
Local Institution - 379
Barcelona, Spain
Local Institution - 375
Barcelona, Spain
Local Institution - 376
Cáceres, Spain
Local Institution - 378
Madrid, Spain
Local Institution - 381
Madrid, Spain
Local Institution - 380
Málaga, Spain
Local Institution - 377
Valencia, Spain
Local Institution - UNK-52
Gothenburg, 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