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
- Diseases
- Acute myeloid leukemia
- 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
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 178 Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Local Institution - 175 Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Local Institution - 177 Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Local Institution - UNK-121 Coordinator of this site? Confirm its status | Yvoir | Belgium | Unknown status |
| Local Institution - 125 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Local Institution - 403 Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Local Institution - 401 Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Completed |
| Local Institution - 375 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Local Institution - 379 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Local Institution - 376 Coordinator of this site? Confirm its status | Cáceres | Spain | Unknown status |
| Local Institution - 378 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Local Institution - 381 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Local Institution - 380 Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Local Institution - 377 Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Oncopole Claudius Regaud Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| Local Institution - 429 Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Local Institution - 427 Coordinator of this site? Confirm its status | Headington | United Kingdom | Unknown status |
| Local Institution - 428 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 430 Coordinator of this site? Confirm its status | Sutton (Surrey) | United Kingdom | Unknown status |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Completed |
| Azienda Sanitaria Territoriale di Pesaro e Urbino Coordinator of this site? Confirm its status | Pesaro | Italy | Completed |
| Local Institution - 351 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 350 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Stichting Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Local Institution - 327 Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Local Institution - UNK-52 Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Local Institution - 902 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 102 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 103 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Local Institution - 108 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Local Institution - 110 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Local Institution - 105 Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Local Institution - 107 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Local Institution - 106 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.