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Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation

Study acronym: AGILE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 81 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Nov 4, 2025, no change to tracked fieldsv80-v81
  2. Study sites: 89 to 90v79
  3. Publications: details revised at 1 of 3 entriesv78
  4. Completion date: Jun 30, 2024 to Jun 30, 2026v77
  5. 2 versions Re-verified since Feb 2, 2024, no change to tracked fieldsv75-v76
Show 43 earlier versionsHide 43 earlier versions
  1. Study sites: 91 to 89v74
  2. Study sites: 89 to 91v73
  3. 2 versions Re-verified since Mar 29, 2023, no change to tracked fieldsv71-v72
  4. Results first posted: Mar 23, 2023v70
  5. Enrollment target: 148 to 146 Primary completion date changed from estimate of Jun 30, 2024 to Mar 18, 2021 · Interventions: AG-120 (ivosidenib) with Azacitidine (Drug), Placebo with Azacitidine (Drug) to AG-120 (Drug), Azacitidine (Drug), Placebo (Drug) · Secondary endpoints: 30 to 32 · 2 morev69 Show 5 more changesShow less
    • Primary completion date changed from estimate of Jun 30, 2024 to Mar 18, 2021
    • Interventions: AG-120 (ivosidenib) with Azacitidine (Drug), Placebo with Azacitidine (Drug) to AG-120 (Drug), Azacitidine (Drug), Placebo (Drug)
    • Secondary endpoints: 30 to 32
    • Study title revised
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Primary and study completion dates: Jun 30, 2022 to Jun 30, 2024v68
  7. Re-verified, no change to tracked fieldsv67
  8. Study sites: 160 to 89v66
  9. Re-verified, no change to tracked fieldsv65
  10. Lead sponsor: Agios Pharmaceuticals, Inc. to Institut de Recherches Internationales Servierv64
  11. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 200 to confirmed 148 · Study sites: 199 to 160v63 Show 2 more changesShow less
    • Enrollment target: estimated 200 to confirmed 148
    • Study sites: 199 to 160
  12. Site details revised at 3 of 199 sitesv62
  13. Site details revised at 1 of 199 sitesv61
  14. Site details revised at 2 of 199 sitesv60
  15. Site details revised at 1 of 199 sitesv59
  16. Study sites: 200 to 199v58
  17. Site details revised at 5 of 200 sitesv57
  18. Study sites: 199 to 200v56
  19. Re-verified, no change to tracked fieldsv55
  20. Primary and study completion dates: Oct 31, 2021 to Jun 30, 2022 Study sites revised (199)v54 Show 1 more changeShow less
    • Study sites revised (199)

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites: 200 to 199v53
  22. Study sites: 201 to 200v52
  23. Secondary endpoints: 29 to 30v51 See this version in full on ClinicalTrials.gov ↗
  24. Enrollment target: 392 to 200 Primary endpoint revised · Study sites: 202 to 201 · Primary completion date: Apr 2022 to Oct 31, 2021 · 3 morev50 Show 6 more changesShow less
    • Primary endpoint revised
    • Study sites: 202 to 201
    • Primary completion date: Apr 2022 to Oct 31, 2021
    • Completion date: Jun 2022 to Oct 31, 2021
    • Eligibility criteria expanded, about 175 words
    • Secondary endpoints: 4 to 29

    See this version in full on ClinicalTrials.gov ↗

  25. Site details revised at 3 of 202 sitesv49
  26. Study sites: 200 to 202v48
  27. Study sites: 203 to 200v47
  28. Study sites revised (203)v46 See this version in full on ClinicalTrials.gov ↗
  29. Study sites revised (203)v45 See this version in full on ClinicalTrials.gov ↗
  30. Site details revised at 7 of 203 sitesv44
  31. Study sites: 201 to 203v43
  32. Study sites: 202 to 201v42
  33. Start date: Mar 19, 2018 to Jun 26, 2017v41
  34. Study sites revised (202)v40 See this version in full on ClinicalTrials.gov ↗
  35. Start date: Jun 20, 2017 to Mar 19, 2018 Study sites: 164 to 202v39 Show 1 more changeShow less
    • Study sites: 164 to 202
  36. Study sites: 163 to 164v38
  37. Study sites: 161 to 163v37
  38. Study sites: 160 to 161v36
  39. Study sites: 159 to 160v35
  40. Study sites: 157 to 159v34
  41. Study sites: 150 to 157v33
  42. Site details revised at 1 of 150 sitesv32
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study.
Trial Details
NCT Number NCT03173248
Lead Sponsor Institut de Recherches Internationales Servier
Conditions Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML, AML Arising From Myelodysplastic Syndrome (MDS), Leukemia, Myeloid, Acute
Enrollment 146 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov