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CINC424A2X01B Rollover Protocol

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 years 6 months later Sep 16, 2027 → Apr 5, 2032
See other at-risk trials from Novartis

Record History

The 50 most recent of 107 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Sep 16, 2027 to Apr 5, 2032 Secondary endpoints revised (2) · Site details revised at 4 of 97 sitesv107 Show 2 more changesShow less
    • Secondary endpoints revised (2)
    • Site details revised at 4 of 97 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Trial status changed: Recruiting → Active, Not Recruiting Trial sites reduced: 101 → 97 locations · Enrollment target: estimated 296 to confirmed 279v106 Show 2 more changesShow less
    • Trial sites reduced: 101 → 97 locations
    • Enrollment target: estimated 296 to confirmed 279
  3. Notable Trial status changed: Active, Not Recruiting → Recruiting Trial sites expanded: 97 → 101 locations · Completion pushed from Sep 16, 2027 to Apr 5, 2032 · Enrollment target: 279 to 296v105 Show 3 more changesShow less
    • Trial sites expanded: 97 → 101 locations
    • Completion pushed from Sep 16, 2027 to Apr 5, 2032
    • Enrollment target: 279 to 296
  4. Minor Site details revised at 3 of 97 sitesv104
  5. Minor Site details revised at 10 of 97 sitesv103
Show 45 earlier versionsHide 45 earlier versions
  1. Minor Study sites: 98 to 97v102
  2. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 356 to confirmed 279 · Study sites: 102 to 98v101 Show 2 more changesShow less
    • Enrollment target: estimated 356 to confirmed 279
    • Study sites: 102 to 98
  3. Notable Trial status: Active, Not Recruiting to Recruiting Enrollment target: 279 to 356 · Study sites: 97 to 102v100 Show 2 more changesShow less
    • Enrollment target: 279 to 356
    • Study sites: 97 to 102
  4. Minor Re-verified, no change to tracked fieldsv99
  5. Minor Site details revised at 1 of 97 sitesv98
  6. Minor 4 versions Re-verified since Feb 11, 2025, no change to tracked fieldsv94-v97
  7. Minor Study sites: 71 to 97v93
  8. Minor Study sites: 97 to 71v92
  9. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 356 to confirmed 279 · Study sites: 100 to 97v91 Show 2 more changesShow less
    • Enrollment target: estimated 356 to confirmed 279
    • Study sites: 100 to 97
  10. Minor Study sites: 99 to 100v90
  11. Minor Study sites: 98 to 99v89
  12. Minor Site details revised at 2 of 98 sitesv88
  13. Minor Site details revised at 3 of 98 sitesv87
  14. Minor Site details revised at 1 of 98 sitesv86
  15. Minor Study sites: 99 to 98v85
  16. Minor Study sites: 100 to 99v84
  17. Minor Site details revised at 4 of 100 sitesv83
  18. Minor Site details revised at 1 of 100 sitesv82
  19. Minor Site details revised at 1 of 100 sitesv81
  20. Minor Study sites: 101 to 100v80
  21. Minor Site details revised at 5 of 101 sitesv79
  22. Minor Site details revised at 4 of 101 sitesv78
  23. Minor Site details revised at 1 of 101 sitesv77
  24. Minor Re-verified, no change to tracked fieldsv76
  25. Minor Site details revised at 2 of 101 sitesv75
  26. Minor Site details revised at 4 of 101 sitesv74
  27. Minor Site details revised at 4 of 101 sitesv73
  28. Minor Study sites: 100 to 101v72
  29. Minor Site details revised at 2 of 100 sitesv71
  30. Minor Site details revised at 1 of 100 sitesv70
  31. Minor Site details revised at 1 of 100 sitesv69
  32. Minor Study sites: 99 to 100v68
  33. Minor Site details revised at 2 of 99 sitesv67
  34. Minor Study sites: 97 to 99v66
  35. Minor Enrollment target: 298 to 356v65
  36. Minor Study sites: 98 to 97v64
  37. Minor Site details revised at 1 of 98 sitesv63
  38. Minor Enrollment target: 356 to 298 Site details revised at 4 of 98 sitesv62 Show 1 more changeShow less
    • Site details revised at 4 of 98 sites
  39. Minor Site details revised at 1 of 98 sitesv61
  40. Notable Primary endpoint revised Study sites: 97 to 98 · Interventions: ruxolitinib tablets or oral pediatric formulation (Drug), ruxolitinib tablets or oral pediatric formulation, panobinostat capsules (Drug) to panobinostat (Drug), ruxolitinib (Drug) · Eligibility criteria shortened, about 713 words · 3 morev60 Show 6 more changesShow less
    • Study sites: 97 to 98
    • Interventions: ruxolitinib tablets or oral pediatric formulation (Drug), ruxolitinib tablets or oral pediatric formulation, panobinostat capsules (Drug) to panobinostat (Drug), ruxolitinib (Drug)
    • Eligibility criteria shortened, about 713 words
    • Secondary endpoints: 1 to 2
    • Study description shortened, about 789 words
    • Study arms: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  41. Minor Study sites: 96 to 97v59
  42. Minor Study sites: 95 to 96v58
  • 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.
555 trials monitored
See 31 trials at risk
2,566 trials monitored
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175 trials monitored
See 8 trials at risk
and 1 more disease
This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.
Trial Details
NCT Number NCT02386800
Lead Sponsor Novartis Pharmaceuticals
Conditions Primary Myelofibrosis, Polycythemia Vera, Graft Versus Host Disease, Acute Myeloid Leukemia, Thalassemia
Enrollment 279 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov