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Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria shortened, about 1 wordv32 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 89 to 90v31
  3. Enrollment increased: 98 → 130 participantsv30
  4. Study sites: 88 to 89v29
  5. Study sites: 87 to 88v28
Show 26 earlier versionsHide 26 earlier versions
  1. Study sites: 86 to 87v27
  2. Study sites: 85 to 86 Eligibility criteria expanded, about 2 wordsv26 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 83 to 85v25
  4. Study sites: 82 to 83v24
  5. Study sites: 79 to 82v23
  6. Study sites: 74 to 79 Completion date: Feb 2032 to Apr 2031 · Eligibility criteria expanded, about 127 words · Secondary endpoints: 13 to 15 · 1 morev22 Show 4 more changesShow less
    • Completion date: Feb 2032 to Apr 2031
    • Eligibility criteria expanded, about 127 words
    • Secondary endpoints: 13 to 15
    • Study description expanded, about 43 words

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 72 to 74v21
  8. Study sites: 70 to 72v20
  9. Study sites: 66 to 70v19
  10. Study sites: 62 to 66v18
  11. Study sites: 58 to 62v17
  12. Study sites: 55 to 58v16
  13. Study sites: 44 to 55v15
  14. Study sites: 32 to 44v14
  15. Study sites: 31 to 32v13
  16. Study sites: 26 to 31v12
  17. Study sites: 21 to 26v11
  18. Study sites: 15 to 21v10
  19. Study sites: 11 to 15v9
  20. Study sites: 1 to 11v8
  21. Start date changed from estimate of Oct 2022 to Oct 1, 2022v7
  22. Start date: Aug 2022 to Oct 2022v6
  23. Start date: Jun 2022 to Aug 2022v5
  24. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v4 Show 1 more changeShow less
    • Study sites: 0 to 1
  25. Start date: May 2022 to Jun 2022v3
  26. Start date: Feb 2022 to May 2022 Study description shortened, about 4 wordsv2 Show 1 more changeShow less
    • Study description shortened, about 4 words

    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin \[GO\]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.
Trial Details
NCT Number NCT05183035
Lead Sponsor PedAL BCU, LLC
Collaborators: Princess Maxima Center for Pediatric Oncology (European Sponsor), AbbVie, Roche-Genentech, EuPAL
Conditions Acute Myeloid Leukemia
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov