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Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv45
  2. Completion date: Jul 2024 to Jul 24, 2026v44
  3. Publications: details revised at 1 of 4 entriesv43
  4. Completion date: Jul 2023 to Jul 2024v42
  5. 4 versions Re-verified since Aug 17, 2021, no change to tracked fieldsv38-v41
Show 36 earlier versionsHide 36 earlier versions
  1. Lead sponsor: Agios Pharmaceuticals, Inc. to Institut de Recherches Internationales Servierv37
  2. 3 versions Re-verified since Sep 24, 2020, no change to tracked fieldsv34-v36
  3. Study sites: 14 to 17v33
  4. 5 versions Re-verified since Mar 25, 2020, no change to tracked fieldsv28-v32
  5. Primary endpoint revised Eligibility criteria expanded, about 56 words · Secondary endpoints revised (4) · Study title expanded, about 1 wordv27 Show 3 more changesShow less
    • Eligibility criteria expanded, about 56 words
    • Secondary endpoints revised (4)
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Completion date: Jul 2020 to Jul 2023v26
  7. Study sites: 16 to 14v25
  8. 2 versions Re-verified since Oct 23, 2019, no change to tracked fieldsv23-v24
  9. Study sites revised (16)v22 See this version in full on ClinicalTrials.gov ↗
  10. 3 versions Re-verified since Jun 26, 2019, no change to tracked fieldsv19-v21
  11. Study sites: 15 to 16v18
  12. Start date: Dec 2015 to Dec 31, 2015v17
  13. Primary completion date changed from estimate of Dec 2018 to Dec 13, 2018v16
  14. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 144 to confirmed 153 · Study sites: 16 to 15 · Primary completion date: Oct 2018 to Dec 2018 · 1 morev15 Show 4 more changesShow less
    • Enrollment target: estimated 144 to confirmed 153
    • Study sites: 16 to 15
    • Primary completion date: Oct 2018 to Dec 2018
    • Completion date: Sep 2020 to Jul 2020
  15. Primary completion date: May 2018 to Oct 2018 Study sites revised (16) · Eligibility criteria shortened, about 1 wordv14 Show 2 more changesShow less
    • Study sites revised (16)
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  16. Re-verified, no change to tracked fieldsv13
  17. Enrollment target: 120 to 144 Study arms: 4 to 6 · Eligibility criteria shortened, about 2 wordsv12 Show 2 more changesShow less
    • Study arms: 4 to 6
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  18. Study sites revised (16)v11 See this version in full on ClinicalTrials.gov ↗
  19. Enrollment target: 90 to 120 Primary completion date: Mar 2018 to May 2018 · Completion date: Dec 2020 to Sep 2020 · Eligibility criteria expanded, about 40 words · 1 morev10 Show 4 more changesShow less
    • Primary completion date: Mar 2018 to May 2018
    • Completion date: Dec 2020 to Sep 2020
    • Eligibility criteria expanded, about 40 words
    • Study sites revised (16)

    See this version in full on ClinicalTrials.gov ↗

  20. Study sites: 15 to 16 Eligibility criteria expanded, about 32 wordsv9 Show 1 more changeShow less
    • Eligibility criteria expanded, about 32 words

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites revised (15)v8 See this version in full on ClinicalTrials.gov ↗
  22. Study sites revised (15)v7 See this version in full on ClinicalTrials.gov ↗
  23. Study sites revised (15)v6 See this version in full on ClinicalTrials.gov ↗
  24. Study sites revised (15)v5 See this version in full on ClinicalTrials.gov ↗
  25. Study sites revised (15)v4 See this version in full on ClinicalTrials.gov ↗
  26. Study sites revised (15)v3 See this version in full on ClinicalTrials.gov ↗
  27. Trial status: Not Yet Recruiting to Recruiting Study sites revised (15)v2 Show 1 more changeShow less
    • Study sites revised (15)

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • 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.
The purpose of this Phase I, multicenter, clinical trial is to evaluate the safety of AG-120 and AG-221 when given in combination with standard AML induction and consolidation therapy. The study plans to evaluate up to 2 dose levels of AG-120 in participants with an isocitrate dehydrogenase protein 1 (IDH1) mutation and up to 2 dose levels of AG-221 in participants with an isocitrate dehydrogenase protein 2 (IDH2) mutation. AG-120 or AG-221 will be administered with 2 types of AML induction therapies (cytarabine with either daunorubicin or idarubicin) and 2 types of AML consolidation therapies (mitoxantrone with etoposide \[ME\] or cytarabine). After consolidation therapy, participants may continue on to maintenance therapy and receive daily treatment with single-agent AG-120 or AG-221 until relapse, development of an unacceptable toxicity, or hematopoietic stem cell transplant (HSCT). The study will end when all participants have discontinued study treatment.
Trial Details
NCT Number NCT02632708
Lead Sponsor Institut de Recherches Internationales Servier
Collaborators: Celgene Corporation
Conditions Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML, AML Arising From Myelodysplastic Syndrome (MDS), AML Arising From Antecedent Hematologic Disorder (AHD), AML Arising After Exposure to Genotoxic Injury
Enrollment 153 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov