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CAR-T Long Term Follow Up (LTFU) Study

Study acronym: PAVO
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years 1 month later Feb 22, 2036 → Apr 18, 2039
Enrollment reduced 21% 1400 → 1105 participants
See other at-risk trials from Novartis

Record History

The 50 most recent of 61 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Feb 22, 2036 to Apr 18, 2039 Enrollment reduced: 1400 → 1105 participants · Study sites: 118 to 120 · Secondary endpoints: details revised at 1 of 5 entries · 1 more Show 4 more changesShow less
    • Enrollment reduced: 1400 → 1105 participants
    • Study sites: 118 to 120
    • Secondary endpoints: details revised at 1 of 5 entries
    • Eligibility criteria expanded, about 3 words
  2. Study sites: 109 to 118v60
  3. Study sites: 96 to 109v59
  4. Study sites: 95 to 96v58
  5. Study sites: 87 to 95v57
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 77 to 87v56
  2. Start date: Jan 5, 2016 to Nov 2, 2015 Site details revised at 8 of 77 sitesv55 Show 1 more changeShow less
    • Site details revised at 8 of 77 sites
  3. Study sites: 73 to 77v54
  4. Study sites: 77 to 73v53
  5. Study sites: 76 to 77v52
  6. Start date: Nov 2, 2015 to Jan 5, 2016 Study sites: 74 to 76v51 Show 1 more changeShow less
    • Study sites: 74 to 76
  7. Phase: Not applicable to Phase 3 Site contacts updated at 3 of 74 sitesv50 Show 1 more changeShow less
    • Site contacts updated at 3 of 74 sites
  8. Study sites: 72 to 74v49
  9. Study sites revised (72)v48 See this version in full on ClinicalTrials.gov ↗
  10. Site details revised at 6 of 72 sitesv47
  11. Site details revised at 1 of 72 sitesv46
  12. Site details revised at 3 of 72 sitesv45
  13. Site details revised at 1 of 72 sitesv44
  14. Study sites: 71 to 72v43
  15. Enrollment target: 1250 to 1400 Study sites: 70 to 71v42 Show 1 more changeShow less
    • Study sites: 70 to 71
  16. Study sites: 71 to 70v41
  17. Study sites: 69 to 71v40
  18. Re-verified, no change to tracked fieldsv39
  19. Study sites: 68 to 69v38
  20. Study sites: 66 to 68v37
  21. Study sites: 65 to 66v36
  22. Study sites: 64 to 65v35
  23. Study sites: 63 to 64v34
  24. Primary completion date: Apr 27, 2035 to Feb 22, 2036 Primary endpoint revised · Study sites: 62 to 63 · Completion date: Apr 28, 2035 to Feb 22, 2036 · 1 morev33 Show 4 more changesShow less
    • Primary endpoint revised
    • Study sites: 62 to 63
    • Completion date: Apr 28, 2035 to Feb 22, 2036
    • Secondary endpoints revised (5)

    See this version in full on ClinicalTrials.gov ↗

  25. Study sites: 61 to 62v32
  26. Study sites: 59 to 61v31
  27. Study sites: 58 to 59v30
  28. Site details revised at 1 of 58 sitesv29
  29. Study sites: 57 to 58v28
  30. Study sites: 56 to 57v27
  31. Primary completion date: Dec 28, 2034 to Apr 27, 2035 Completion date: May 17, 2035 to Apr 28, 2035 · Interventions: Previously treated CART CD 19 patients (Genetic) to Previously treated CAR-T patients (Genetic) · Site contacts updated at 5 of 56 sitesv26 Show 3 more changesShow less
    • Completion date: May 17, 2035 to Apr 28, 2035
    • Interventions: Previously treated CART CD 19 patients (Genetic) to Previously treated CAR-T patients (Genetic)
    • Site contacts updated at 5 of 56 sites
  32. Study sites: 55 to 56v25
  33. Study sites: 54 to 55v24
  34. Study sites: 53 to 54v23
  35. Enrollment target: 620 to 1250 Study sites: 52 to 53v22 Show 1 more changeShow less
    • Study sites: 52 to 53
  36. Study sites: 51 to 52v21
  37. Study sites: 50 to 51v20
  38. Study sites: 49 to 50v19
  39. Study sites: 48 to 49v18
  40. Study sites: 47 to 48v17
  41. Study sites: 46 to 47v16
  42. Study sites: 45 to 46v15
  43. Study sites: 44 to 45v14
  44. Study sites: 43 to 44v13
  45. Study sites: 41 to 43v12
  • 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
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.
Trial Details
NCT Number NCT02445222
Lead Sponsor Novartis Pharmaceuticals
Collaborators: University of Pennsylvania
Conditions Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Enrollment 1,105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov