Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03897127 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 67 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv67
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 64 to 62
    v66
  3. Primary and study completion dates: Mar 2024 to Jun 2027
    • Study sites revised (64)
    • Eligibility criteria expanded, about 3 words
    v65
  4. Site details revised at 1 of 64 sitesv64
  5. Study sites: 63 to 64v63
Show 45 earlier versionsHide 45 earlier versions
  1. Site contacts updated at 2 of 63 sitesv62
  2. Site contacts updated at 1 of 63 sitesv61
  3. Site contacts updated at 1 of 63 sitesv60
  4. Site contacts updated at 2 of 63 sitesv59
  5. Site details revised at 1 of 63 sitesv58
  6. Site details revised at 1 of 63 sitesv57
  7. Site contacts updated at 2 of 63 sitesv56
  8. Site contacts updated at 1 of 63 sitesv55
  9. Site details revised at 1 of 63 sitesv54
  10. Study sites: 58 to 63v53
  11. Study sites: 60 to 58v52
  12. Site details revised at 1 of 60 sitesv51
  13. Site details revised at 1 of 60 sitesv50
  14. Site details revised at 1 of 60 sitesv49
  15. Primary endpoint revisedv48 Show 4 more changesShow less
    • Enrollment target: 593 to 882
    • Eligibility criteria expanded, about 80 words
    • Secondary endpoints: 6 to 4
    • Site contacts updated at 1 of 60 sites
  16. Site details revised at 1 of 60 sitesv47
  17. Study sites: 58 to 60v46
  18. Site details revised at 1 of 58 sitesv45
  19. Site contacts updated at 1 of 58 sitesv44
  20. Study sites: 57 to 58v43
  21. Site details revised at 1 of 57 sitesv42
  22. Site details revised at 2 of 57 sitesv41
  23. Site details revised at 1 of 57 sitesv40
  24. Study sites: 51 to 57v39
  25. Site details revised at 2 of 51 sitesv38
  26. Site details revised at 1 of 51 sitesv37
  27. Site details revised at 1 of 51 sitesv36
  28. Site details revised at 1 of 51 sitesv35
  29. Site details revised at 1 of 51 sitesv34
  30. Site details revised at 1 of 51 sitesv33
  31. Site details revised at 1 of 51 sitesv32
  32. Study sites: 49 to 51v31
  33. Site details revised at 1 of 49 sitesv30
  34. Site details revised at 1 of 49 sitesv29
  35. Study sites: 48 to 49v28
  36. Study sites revised (48)v27
  37. Site details revised at 1 of 48 sitesv26
  38. Site details revised at 3 of 48 sitesv25
  39. Study sites: 47 to 48v24
  40. Site details revised at 1 of 47 sitesv23
  41. Site details revised at 1 of 47 sitesv22
  42. Primary and study completion dates: Jun 2023 to Mar 2024
    • Study sites: 45 to 47
    • Eligibility criteria shortened, about 19 words
    v21
  43. Site details revised at 1 of 45 sitesv20
  44. Site details revised at 4 of 45 sitesv19
  45. Site details revised at 1 of 45 sitesv18
  • 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 trial is a randomized, open-label phase III study comparing CPX-351 vs conventional intensive induction and consolidation chemotherapy in patients with newly diagnosed AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria), including AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML according to the World Health Organization (WHO) classification. Overall survival (OS) in the restricted set of de novo patients will be the primary endpoint.
Trial Details
NCT Number NCT03897127
Lead Sponsor University of Ulm
Collaborators: Jazz Pharmaceuticals
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 882 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov