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Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

StatusRecruiting
PhasePhase 3
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 11 of 14 entries
    • Site details revised at 2 of 91 sites
  2. Site details revised at 2 of 91 sitesv48
  3. Site details revised at 1 of 91 sitesv47
  4. Site details revised at 1 of 91 sitesv46
  5. Site details revised at 1 of 91 sitesv45
Show 43 earlier versionsHide 43 earlier versions
  1. Site details revised at 3 of 91 sitesv44
  2. Site details revised at 1 of 91 sitesv43
  3. Site details revised at 1 of 91 sitesv42
  4. Site details revised at 1 of 91 sitesv41
  5. Site details revised at 3 of 91 sitesv40
  6. Site details revised at 1 of 91 sitesv39
  7. Site details revised at 2 of 91 sitesv38
  8. Site details revised at 1 of 91 sitesv37
  9. Site details revised at 1 of 91 sitesv36
  10. Site details revised at 1 of 91 sitesv35
  11. Site details revised at 1 of 91 sitesv34
  12. Site details revised at 5 of 91 sitesv33
  13. Site details revised at 3 of 91 sitesv32
  14. Site details revised at 7 of 91 sitesv31
  15. Site details revised at 3 of 91 sitesv30
  16. Site contacts updated at 1 of 91 sitesv29
  17. Site details revised at 1 of 91 sitesv28
  18. Study sites: 90 to 91v27
  19. Site details revised at 1 of 90 sitesv26
  20. Site details revised at 1 of 90 sitesv25
  21. Study sites: 85 to 90v24
  22. Site details revised at 2 of 85 sitesv23
  23. Site details revised at 7 of 85 sitesv22
  24. Secondary endpoints: 10 to 14v21
  25. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 12 to 85
    • Interventions: Allogeneic stem cell transplantation (Other), Autologous stem cell transplantation (Other), Placebo (Drug), Standard chemotherapy… to Allogeneic stem cell transplantation (Other), Placebo (Drug), Standard chemotherapy (Combination Product), Venetoclax (Drug)
    • Eligibility criteria shortened, about 452 words
    v20
  26. Primary completion date: Feb 1, 2025 to Mar 2029
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Feb 1, 2031 to Feb 2032
    • Site details revised at 12 of 12 sites
    v19
  27. Re-verified, no change to tracked fieldsv18
  28. Study sites: 11 to 12v17
  29. Site contacts updated at 1 of 11 sitesv16
  30. Study sites: 10 to 11v15
  31. Study sites: 9 to 10v14
  32. Study sites: 8 to 9v13
  33. Study sites: 7 to 8v12
  34. Study sites: 6 to 7v11
  35. Study sites: 5 to 6v10
  36. Study sites: 4 to 5v9
  37. Study sites: 3 to 4v8
  38. Study sites: 2 to 3v7
  39. Study sites: 1 to 2v6
  40. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 1, 2022 to Sep 13, 2022
    • Site details revised
    v5
  41. Start date: Oct 30, 2021 to Jun 1, 2022v4
  42. Start date: Aug 1, 2021 to Oct 30, 2021v3
  43. Start date: Feb 1, 2021 to Aug 1, 2021v2
  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 Randomized, Placebo-Controlled Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2
Trial Details
NCT Number NCT04628026
Lead Sponsor University of Ulm
Collaborators: Stichting Hemato-Oncologie voor Volwassenen Nederland
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov