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Study of Efficacy and Safety of Ruxolitinib in Patients With Grade II to IV Steroid-refractory Acute Graft vs. Host Disease

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Sep 2, 2026 to Sep 3, 2026 Eligibility criteria expanded, about 17 words · Secondary endpoints: details revised at 4 of 10 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 4 of 10 entries
  2. Site details revised at 1 of 9 sitesv18
  3. Re-verified, no change to tracked fieldsv17
  4. Trial sites reduced: 17 → 9 locationsv16
  5. Enrollment closed, study ongoing Primary completion date: Sep 24, 2026 to Sep 2, 2026 · Completion date: Jun 21, 2027 to Jul 8, 2027 · Site details revised at 17 of 17 sitesv15 Show 3 more changesShow less
    • Primary completion date: Sep 24, 2026 to Sep 2, 2026
    • Completion date: Jun 21, 2027 to Jul 8, 2027
    • Site details revised at 17 of 17 sites
  6. Primary completion moved earlier from Jan 4, 2027 to Sep 24, 2026 Completion moved earlier from Feb 17, 2028 to Jun 21, 2027 · Site details revised at 16 of 17 sitesv14 Show 2 more changesShow less
    • Completion moved earlier from Feb 17, 2028 to Jun 21, 2027
    • Site details revised at 16 of 17 sites
  7. Enrollment target: 54 to 36 Site details revised at 1 of 17 sites · Eligibility criteria expanded, about 3 wordsv13 Show 2 more changesShow less
    • Site details revised at 1 of 17 sites
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 16 to 17v12
  9. Primary completion date: Sep 22, 2025 to Jan 4, 2027 Study sites: 15 to 16 · Completion date: Nov 5, 2026 to Feb 17, 2028v11 Show 2 more changesShow less
    • Study sites: 15 to 16
    • Completion date: Nov 5, 2026 to Feb 17, 2028
  10. Study sites: 16 to 15v10
  11. Study sites: 15 to 16v9
  12. Study sites: 14 to 15v8
  13. Primary completion date: Nov 7, 2025 to Sep 22, 2025v7
  14. Study sites: 13 to 14v6
  15. Study sites: 11 to 13 Primary completion date: Apr 8, 2026 to Nov 7, 2025v5 Show 1 more changeShow less
    • Primary completion date: Apr 8, 2026 to Nov 7, 2025
  16. Study sites: 9 to 11v4
  17. Study sites: 4 to 9 Start date changed from estimate of Jun 30, 2024 to Jul 4, 2024v3 Show 1 more changeShow less
    • Start date changed from estimate of Jun 30, 2024 to Jul 4, 2024
  18. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Eligibility criteria revised · Secondary endpoints revised (10)v2 Show 3 more changesShow less
    • Study sites: 0 to 4
    • Eligibility criteria revised
    • Secondary endpoints revised (10)

    See this version in full on ClinicalTrials.gov ↗

  19. 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.
Novartis
555 trials monitored
See 31 trials at risk
The purpose of this study is to assess the efficacy and safety of ruxolitinib therapy in Chinese adults and adolescents (≥ 12 years old) with Grade II-IV steroid-refractory acute graft versus host disease (SR-aGvHD).
Trial Details
NCT Number NCT06462469
Lead Sponsor Novartis Pharmaceuticals
Conditions Steroid-refractory Acute Graft Versus Host Disease
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov