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A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy

Study acronym: ALLELE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 60 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Study sites revised (71)v60 See this version in full on ClinicalTrials.gov ↗
  2. Re-verified, no change to tracked fieldsv59
  3. Site details revised at 3 of 71 sitesv58
  4. Site details revised at 2 of 71 sitesv57
  5. Site details revised at 1 of 71 sitesv56
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 13 of 71 sitesv55
  2. Re-verified, no change to tracked fieldsv54
  3. Enrollment target: 66 to 115 Eligibility criteria expanded, about 10 words · Secondary endpoints revised (9) · Study description expanded, about 81 words · 2 morev53 Show 5 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (9)
    • Study description expanded, about 81 words
    • Study sites revised (71)
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Aug 2025 to May 31, 2030 Site contacts updated at 1 of 71 sitesv52 Show 1 more changeShow less
    • Site contacts updated at 1 of 71 sites
  5. Completion date: Jun 2027 to Aug 2030 Eligibility criteria revised · Secondary endpoints revised (9) · Primary endpoint revised · 1 morev51 Show 4 more changesShow less
    • Eligibility criteria revised
    • Secondary endpoints revised (9)
    • Primary endpoint revised
    • Site details revised at 49 of 71 sites

    See this version in full on ClinicalTrials.gov ↗

  6. Site details revised at 2 of 71 sitesv50
  7. Lead sponsor: Atara Biotherapeutics to Pierre Fabre Medicament Site details revised at 19 of 71 sitesv49 Show 1 more changeShow less
    • Site details revised at 19 of 71 sites
  8. Site details revised at 1 of 71 sitesv48
  9. Site details revised at 12 of 71 sitesv47
  10. Site details revised at 33 of 71 sitesv46
  11. Site details revised at 2 of 71 sitesv45
  12. Study sites revised (71)v44 See this version in full on ClinicalTrials.gov ↗
  13. Site details revised at 4 of 71 sitesv43
  14. Primary completion date: Jun 2022 to Aug 2025 Primary endpoint revised · Eligibility criteria expanded, about 17 words · Secondary endpoints: 7 to 9 · 2 morev42 Show 5 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 7 to 9
    • Study description expanded, about 18 words
    • Study sites revised (71)

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 70 to 71v41
  16. Site details revised at 2 of 70 sitesv40
  17. Study sites: 69 to 70v39
  18. Site contacts updated at 1 of 69 sitesv38
  19. Study sites: 68 to 69v37
  20. Study sites revised (68)v36 See this version in full on ClinicalTrials.gov ↗
  21. Study sites: 66 to 68v35
  22. Study sites: 65 to 66 Eligibility criteria expanded, about 9 wordsv34 Show 1 more changeShow less
    • Eligibility criteria expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  23. Study sites: 64 to 65v33
  24. Study sites: 63 to 64v32
  25. Study sites: 61 to 63v31
  26. Study sites: 59 to 61v30
  27. Site details revised at 1 of 59 sites Eligibility criteria shortened, about 3 wordsv29 Show 1 more changeShow less
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  28. Study sites: 54 to 59v28
  29. Study sites: 53 to 54 Eligibility criteria expanded, about 1 wordv27 Show 1 more changeShow less
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  30. Primary completion date: Nov 2020 to Jun 2022 Study sites: 52 to 53 · Completion date: Nov 2020 to Jun 2027 · Eligibility criteria shortened, about 17 words · 1 morev26 Show 4 more changesShow less
    • Study sites: 52 to 53
    • Completion date: Nov 2020 to Jun 2027
    • Eligibility criteria shortened, about 17 words
    • Study description expanded, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  31. Site details revised at 2 of 52 sitesv25
  32. Study sites: 47 to 52v24
  33. Study sites: 46 to 47v23
  34. Study sites: 43 to 46v22
  35. Site details revised at 1 of 43 sitesv21
  36. Study sites: 40 to 43v20
  37. Study sites: 38 to 40v19
  38. Study sites: 36 to 38v18
  39. Study sites: 34 to 36 Study description expanded, about 20 wordsv17 Show 1 more changeShow less
    • Study description expanded, about 20 words

    See this version in full on ClinicalTrials.gov ↗

  40. Study sites: 32 to 34v16
  41. Study sites: 30 to 32v15
  42. Study sites: 27 to 30v14
  43. Eligibility criteria expanded, about 164 words Secondary endpoints: 9 to 7 · Study description shortened, about 10 words · Site details revised at 2 of 27 sites · 2 morev13 Show 5 more changesShow less
    • Secondary endpoints: 9 to 7
    • Study description shortened, about 10 words
    • Site details revised at 2 of 27 sites
    • Study arms: 1 to 3
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  44. Study sites: 25 to 27 Eligibility criteria revisedv12 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  45. Study sites: 24 to 25v11
  • 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 purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab (SOT-R) and rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.
Trial Details
NCT Number NCT03394365
Lead Sponsor Pierre Fabre Medicament
Conditions Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders, Allogeneic Hematopoietic Cell Transplant, Stem Cell Transplant Complications
Enrollment 115 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov