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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Leukemia, Myeloid, Acute

In brief

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.

Key facts

Study ID

NCT02677922

Run by

Celgene

People needed

130

Starts

2016-06-03

Expected to finish

2026-09-30

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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