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NCT02677922Active, not recruitingPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 19 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
130 (actual)
First submitted
5 Feb 2016
Start date
3 Jun 2016
Primary completion date
2 Aug 2018
Lead sponsor
Celgene
NCT number
NCT02677922
EU CT number
2024-511722-31-00
EudraCT number
2015-003951-23

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 130
  • From 3 Jun 2016 to the primary completion date, 2 Aug 2018
  • 38 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received a targeted agent against an isocitrate dehydrogenase 1 (IDH1) or isocitrate dehydrogenase 2 (IDH2) mutation

Other

  • Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype
  • AML secondary to chronic myelogenous leukemia (CML)
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Local Institution - 178
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AdelaideAustraliaUnknown status
Local Institution - 175
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MelbourneAustraliaUnknown status
Local Institution - 177
Coordinator of this site? Confirm its status
PerthAustraliaUnknown status
Local Institution - UNK-121
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YvoirBelgiumUnknown status
Local Institution - 125
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TorontoCanadaUnknown status
Local Institution - 403
Coordinator of this site? Confirm its status
BaselSwitzerlandUnknown status
Local Institution - 401
Coordinator of this site? Confirm its status
ZurichSwitzerlandUnknown status
Medizinische Hochschule Hannover
Coordinator of this site? Confirm its status
HanoverGermanyCompleted
Universitaetsklinikum Ulm AoR
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UlmGermanyCompleted
Local Institution - 375
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BarcelonaSpainUnknown status
Local Institution - 379
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Local Institution - 376
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CáceresSpainUnknown status
Local Institution - 378
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Local Institution - 381
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Local Institution - 380
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MálagaSpainUnknown status
Local Institution - 377
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ValenciaSpainUnknown status
Oncopole Claudius Regaud
Coordinator of this site? Confirm its status
Toulouse Cedex 9FranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
Local Institution - 429
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BirminghamUnited KingdomUnknown status
Local Institution - 427
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HeadingtonUnited KingdomUnknown status
Local Institution - 428
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LondonUnited KingdomUnknown status
Local Institution - 430
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Sutton (Surrey)United KingdomUnknown status
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyCompleted
Azienda Sanitaria Territoriale di Pesaro e Urbino
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PesaroItalyCompleted
Local Institution - 351
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SeoulSouth KoreaUnknown status
Local Institution - 350
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SeoulSouth KoreaUnknown status
Stichting Amsterdam UMC
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AmsterdamNetherlandsCompleted
Local Institution - 327
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LisbonPortugalUnknown status
Local Institution - UNK-52
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GothenburgSwedenUnknown status
Local Institution - 902
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BostonUnited StatesUnknown status
Beth Israel Deaconess Medical Center
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BostonUnited StatesUnknown status
Local Institution - 102
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BostonUnited StatesUnknown status
Local Institution - 103
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ChicagoUnited StatesUnknown status
Local Institution - 108
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Local Institution - 110
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Local Institution - 105
Coordinator of this site? Confirm its status
DuarteUnited StatesUnknown status
Local Institution - 107
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New HavenUnited StatesUnknown status
Local Institution - 106
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.