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Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 2 of 2 changed
See other at-risk trials from University of Colorado, Denver

Record History

  1. Primary endpoint(s) modified Results posted: Sep 29, 2026 · Trial arms changed: 2 → 6 · Eligibility criteria expanded, about 27 words · 2 more Show 5 more changesShow less
    • Results posted: Sep 29, 2026
    • Trial arms changed: 2 → 6
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Publications: details revised at 1 of 1 entry
  2. Primary endpoints revised (2)v18 See this version in full on ClinicalTrials.gov ↗
  3. Enrollment target: 28 to 29 Secondary endpoints: 4 to 3 · Study arms: 2 to 5v17 Show 2 more changesShow less
    • Secondary endpoints: 4 to 3
    • Study arms: 2 to 5

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date changed from estimate of Aug 16, 2026 to Oct 7, 2025v16
  5. Primary completion date: Aug 16, 2025 to Aug 16, 2026v15
Show 13 earlier versionsHide 13 earlier versions
  1. Primary completion date: Aug 16, 2024 to Aug 16, 2025v14
  2. Enrollment target: 29 to 28 Primary completion date: May 16, 2024 to Aug 16, 2024v13 Show 1 more changeShow less
    • Primary completion date: May 16, 2024 to Aug 16, 2024
  3. Completion date: Jun 2026 to Jun 2027v12
  4. Primary completion date changed from estimate of Dec 14, 2024 to May 16, 2024v11
  5. Primary completion date: Apr 14, 2024 to Dec 14, 2024v10
  6. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 45 to confirmed 29 · Site details revisedv9 Show 2 more changesShow less
    • Enrollment target: estimated 45 to confirmed 29
    • Site details revised
  7. Primary completion date: Jun 2025 to Apr 14, 2024 Enrollment target: 51 to 45v8 Show 1 more changeShow less
    • Enrollment target: 51 to 45
  8. Site contact updatedv7
  9. Re-verified, no change to tracked fieldsv6
  10. Eligibility criteria expanded, about 64 words Study description expanded, about 45 wordsv5 Show 1 more changeShow less
    • Study description expanded, about 45 words

    See this version in full on ClinicalTrials.gov ↗

  11. Eligibility criteria expanded, about 28 words Site contact updatedv4 Show 1 more changeShow less
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  12. Re-verified, no change to tracked fieldsv3
  13. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 2018 to Sep 17, 2018 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Aug 2018 to Sep 17, 2018
    • Site details revised
  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.
This study will treat patients with previously untreated high grade myleodysplastic syndromes (MDS) with both omacetaxine mepesuccinate and azacitidine.
Trial Details
NCT Number NCT03564873
Lead Sponsor University of Colorado, Denver
Conditions High Grade Myelodysplastic Syndromes
Enrollment 29 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov