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Asciminib Roll-over Study

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 54 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 85 sitesv54
  2. Study sites: 84 to 85v53
  3. Primary completion date: Aug 29, 2030 to Aug 30, 2030 Site details revised at 8 of 84 sitesv52 Show 1 more changeShow less
    • Site details revised at 8 of 84 sites
  4. Site contacts updated at 1 of 84 sitesv51
  5. Study sites: 83 to 84v50
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 6 of 83 sitesv49
  2. Site details revised at 8 of 83 sitesv48
  3. Re-verified, no change to tracked fieldsv47
  4. Primary completion date: Aug 30, 2030 to Aug 29, 2030 Site details revised at 8 of 83 sitesv46 Show 1 more changeShow less
    • Site details revised at 8 of 83 sites
  5. Interventions: Asciminib single agent (Drug), Bosutinib (Drug), Dasatinib (Drug), Imatinib (Drug), Nilotinib (Drug) to Asciminib single agent (Drug), Asciminib single agent pediatric formulation (Drug), Bosutinib (Drug), Dasatinib (Drug), Imatinib (Drug)… Site details revised at 5 of 83 sites · Study arms: 10 to 11v45 Show 2 more changesShow less
    • Site details revised at 5 of 83 sites
    • Study arms: 10 to 11
  6. Study sites: 82 to 83v44
  7. Study sites: 79 to 82v43
  8. Site details revised at 3 of 79 sitesv42
  9. Study sites: 78 to 79v41
  10. Start date: Aug 31, 2022 to Aug 30, 2022 Site details revised at 4 of 78 sitesv40 Show 1 more changeShow less
    • Site details revised at 4 of 78 sites
  11. Study sites: 77 to 78 Start date: Aug 30, 2022 to Aug 31, 2022v39 Show 1 more changeShow less
    • Start date: Aug 30, 2022 to Aug 31, 2022
  12. Site details revised at 1 of 77 sitesv38
  13. Study sites: 70 to 77v37
  14. Study sites: 65 to 70v36
  15. Study sites: 64 to 65v35
  16. Study sites: 52 to 64v34
  17. Primary endpoint revised Primary completion date: Aug 29, 2030 to Aug 30, 2030 · Interventions: Asciminib (Drug), Asciminib single agent (Drug), Bosutinib (Drug), Dasatinib (Drug), Imatinib (Drug), Nilotinib (Drug) to Asciminib single agent (Drug), Bosutinib (Drug), Dasatinib (Drug), Imatinib (Drug), Nilotinib (Drug) · Eligibility criteria expanded, about 23 words · 4 morev33 Show 7 more changesShow less
    • Primary completion date: Aug 29, 2030 to Aug 30, 2030
    • Interventions: Asciminib (Drug), Asciminib single agent (Drug), Bosutinib (Drug), Dasatinib (Drug), Imatinib (Drug), Nilotinib (Drug) to Asciminib single agent (Drug), Bosutinib (Drug), Dasatinib (Drug), Imatinib (Drug), Nilotinib (Drug)
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description shortened, about 14 words
    • Site details revised at 1 of 52 sites
    • Study arms: 8 to 10

    See this version in full on ClinicalTrials.gov ↗

  18. Primary completion date: Aug 27, 2027 to Aug 29, 2030 Completion date: Aug 30, 2027 to Aug 30, 2030 · Site details revised at 3 of 52 sitesv32 Show 2 more changesShow less
    • Completion date: Aug 30, 2027 to Aug 30, 2030
    • Site details revised at 3 of 52 sites
  19. Site details revised at 1 of 52 sitesv31
  20. Site details revised at 2 of 52 sitesv30
  21. Site details revised at 2 of 52 sitesv29
  22. Study sites revised (52)v28 See this version in full on ClinicalTrials.gov ↗
  23. Phase: Phase 3 to Phase 4 Study sites: 50 to 52 · Primary completion date: Aug 30, 2027 to Aug 27, 2027v27 Show 2 more changesShow less
    • Study sites: 50 to 52
    • Primary completion date: Aug 30, 2027 to Aug 27, 2027
  24. Phase: Phase 4 to Phase 3 Study sites: 48 to 50v26 Show 1 more changeShow less
    • Study sites: 48 to 50
  25. Study sites: 40 to 48v25
  26. Study sites: 37 to 40v24
  27. Study sites: 33 to 37v23
  28. Study sites: 32 to 33v22
  29. Study sites: 30 to 32v21
  30. Study sites: 29 to 30v20
  31. Study sites: 27 to 29v19
  32. Study sites: 20 to 27v18
  33. Study sites: 18 to 20v17
  34. Study sites: 17 to 18v16
  35. Study sites: 16 to 17v15
  36. Study sites: 10 to 16v14
  37. Study sites: 7 to 10v13
  38. Study sites: 6 to 7v12
  39. Study sites: 2 to 6v11
  40. Study sites: 1 to 2v10
  41. Primary and study completion dates: Aug 16, 2027 to Aug 30, 2027 Start date: Aug 16, 2022 to Aug 30, 2022v9 Show 1 more changeShow less
    • Start date: Aug 16, 2022 to Aug 30, 2022
  42. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: May 29, 2026 to Aug 16, 2027 · Study sites: 0 to 1v8 Show 2 more changesShow less
    • Primary and study completion dates: May 29, 2026 to Aug 16, 2027
    • Study sites: 0 to 1
  43. Enrollment target: 390 to 347 Start date: Aug 12, 2022 to Aug 16, 2022v7 Show 1 more changeShow less
    • Start date: Aug 12, 2022 to Aug 16, 2022
  44. Start date: May 16, 2022 to Aug 12, 2022 Primary and study completion dates: Jan 12, 2027 to May 29, 2026v6 Show 1 more changeShow less
    • Primary and study completion dates: Jan 12, 2027 to May 29, 2026
  45. Phase: Phase 3 to Phase 4 Enrollment target: 230 to 390 · Interventions: Asciminib (Drug), Asciminib single agent (Drug), Bosutinib (Drug), ECG (Procedure), Imatinib (Drug), Nilotinib (Drug), Pregnancy test… to Asciminib (Drug), Asciminib single agent (Drug), Bosutinib (Drug), Dasatinib (Drug), Imatinib (Drug), Nilotinib (Drug) · Eligibility criteria expanded, about 23 words · 1 morev5 Show 4 more changesShow less
    • Enrollment target: 230 to 390
    • Interventions: Asciminib (Drug), Asciminib single agent (Drug), Bosutinib (Drug), ECG (Procedure), Imatinib (Drug), Nilotinib (Drug), Pregnancy test… to Asciminib (Drug), Asciminib single agent (Drug), Bosutinib (Drug), Dasatinib (Drug), Imatinib (Drug), Nilotinib (Drug)
    • Eligibility criteria expanded, about 23 words
    • Study arms: 7 to 8

    See this version in full on ClinicalTrials.gov ↗

  • 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 is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
Trial Details
NCT Number NCT04877522
Lead Sponsor Novartis Pharmaceuticals
Conditions Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Enrollment 347 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov