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
Sponsor score: 60
ClinicalTrials ID:NCT02677922
This clinical trial evaluates the safety and efficacy of AG-120 or AG-221 combined with azacitidine in AML patients with IDH mutations. Eligible participants include those newly diagnosed with AML, having ≥ 20% leukemic blasts, and an ECOG status of 0-2. Interventions involve specified doses of AG-120, AG-221, and azacitidine administered on designated days. Participants must consent to serial bone marrow biopsies.
Patient Parameters
| Parameter | Options |
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Program Overview
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 105 | 91010-301 | Duarte | California |
| Local Institution - 107 | 06510 | New Haven | Connecticut |
| Local Institution - 108 | 60611 | Chicago | Illinois |
| Local Institution - 103 | 60637 | Chicago | Illinois |
| Local Institution - 102 | 02114 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center | 02115 | Boston | Massachusetts |
| Local Institution - 902 | 02115 | Boston | Massachusetts |
| Local Institution - 106 | 10065 | New York | New York |
| Local Institution - 110 | 75390-85520 | Dallas | Texas |
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