Acute Myeloid Leukemia Clinical Trial
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
Summary
The purpose of this study are
to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and,
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.
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed, primary (ie, de novo) or secondary (progression of Myelodysplastic syndrome [MDS] or myeloproliferative neoplasms [MPN], or therapy-related) acute myeloid leukemia (AML) according to the WHO classification with ≥ 20% leukemic blasts in the bone marrow
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Agree to serial bone marrow aspirate/biopsies
Exclusion Criteria:
Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype
AML secondary to chronic myelogenous leukemia (CML)
Received a targeted agent against an isocitrate dehydrogenase 1 (IDH1) or isocitrate dehydrogenase 2 (IDH2) mutation
Has or is suspected of having central nervous system (CNS) leukemia. Evaluation of cerebrospinal fluid is only required if CNS involvement by leukemia is suspected during screening
Other protocol defined inclusion/exclusion criteria apply
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There are 48 Locations for this study
Duarte California, 91010, United States
New Haven Connecticut, 06510, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
New York New York, 10065, United States
Dallas Texas, 75390, United States
Adelaide South Australia, SA 50, Australia
Melbourne , 3141, Australia
Perth , 6000, Australia
Yvoir , 5530, Belgium
Toronto Ontario, M5G 2, Canada
Lille , 59037, France
Marseille Cedex 9 , 13273, France
Paris Cedex 10 , 75475, France
Pessac , 33604, France
Pierre Benite , 69495, France
Toulouse , 31059, France
Villejuif CEDEX , 94805, France
Berlin , 12200, Germany
Dresden , 01307, Germany
Ulm , 89081, Germany
Bologna, Emilia-Romagna , 40138, Italy
Firenze , 50134, Italy
Genova , 16132, Italy
Orbassano , 10043, Italy
Padova , 35128, Italy
Pesaro , 31122, Italy
Roma , 00189, Italy
Seoul , 135-7, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Utrecht , 3584 , Netherlands
Lisboa , 1169-, Portugal
Barcelona , 08036, Spain
Barcelona , 08907, Spain
Caceres , 10005, Spain
Madrid , 28007, Spain
Madrid , 28033, Spain
Malaga , 29010, Spain
Valencia , 46009, Spain
Göteborg , 413 4, Sweden
Basel , 4031, Switzerland
Zurich , 0, Switzerland
Birmingham , B15 2, United Kingdom
Headington , OX3 9, United Kingdom
London , SE5 9, United Kingdom
Sutton (Surrey) , SM2 5, United Kingdom
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