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IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv14
  2. Primary and study completion dates: Apr 2, 2025 to Apr 2, 2027v13
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 38 of 38 sites
    v12
  4. Site details revised at 3 of 38 sitesv11
  5. Site details revised at 8 of 38 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date: Jan 15, 2022 to Apr 2, 2025
    • Start date: Feb 15, 2019 to May 14, 2019
    • Study sites: 34 to 38
    • Study completion date: Jan 15, 2024 to Apr 2, 2025
    v9
  2. Study sites: 29 to 34v8
  3. Study sites: 16 to 29v7
  4. Study sites: 6 to 16v6
  5. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Study sites: 0 to 6
    • Start date changed from estimate of Jan 15, 2019 to Feb 15, 2019
    • Eligibility criteria shortened, about 2 words
    • Study description shortened, about 2 words
  6. Start date: Dec 1, 2018 to Jan 15, 2019
    • Primary completion date: Dec 1, 2021 to Jan 15, 2022
    • Study completion date: Dec 1, 2023 to Jan 15, 2024
    • Eligibility criteria expanded, about 41 words
    v4
  7. Start date: Aug 1, 2018 to Dec 1, 2018
    • Primary completion date: Aug 1, 2021 to Dec 1, 2021
    • Study completion date: Aug 1, 2023 to Dec 1, 2023
    v3
  8. Eligibility criteria expanded, about 59 words
    • Study description expanded, about 13 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
patients with MDS (Myelodysplastic Syndrome) and mutated IDH1 patients will be treated with AG120 (IDH1 inhibitor)
Trial Details
NCT Number NCT03503409
Lead Sponsor Groupe Francophone des Myelodysplasies
Conditions
(from sponsor)		 Myelodysplastic Syndromes, Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov