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A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv37
  2. Trial status changed: Recruiting → Active, Not Recruiting Site details revised at 40 of 40 sitesv36 Show 1 more changeShow less
    • Site details revised at 40 of 40 sites
  3. Site details revised at 1 of 40 sitesv35
  4. Re-verified, no change to tracked fieldsv34
  5. Eligibility criteria shortened, about 416 words Secondary endpoints: 7 to 8 · Study description expanded, about 31 words · Site details revised at 2 of 40 sites · 1 morev33 Show 4 more changesShow less
    • Secondary endpoints: 7 to 8
    • Study description expanded, about 31 words
    • Site details revised at 2 of 40 sites
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

Show 31 earlier versionsHide 31 earlier versions
  1. Lead sponsor: Atara Biotherapeutics to Pierre Fabre Medicament Completion date: May 2029 to May 2028 · Eligibility criteria expanded, about 6 words · Secondary endpoints revised (7) · 3 morev32 Show 6 more changesShow less
    • Completion date: May 2029 to May 2028
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (7)
    • Study sites revised (40)
    • Study description expanded, about 1 word
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Study Identification, Study Status, Conditionsv31
  3. Site details revised at 10 of 40 sitesv30
  4. Site details revised at 26 of 40 sitesv29
  5. Site details revised at 2 of 40 sitesv28
  6. Site details revised at 2 of 40 sitesv27
  7. Site details revised at 26 of 40 sitesv26
  8. Site details revised at 6 of 40 sitesv25
  9. Site details revised at 1 of 40 sitesv24
  10. Site details revised at 2 of 40 sitesv23
  11. Enrollment target: 228 to 190 Eligibility criteria expanded, about 55 words · Secondary endpoints revised (7) · Study description expanded, about 109 words · 2 morev22 Show 5 more changesShow less
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints revised (7)
    • Study description expanded, about 109 words
    • Site details revised at 3 of 40 sites
    • Study arms: 6 to 5

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 39 to 40v21
  13. Study sites: 38 to 39v20
  14. Study sites: 37 to 38v19
  15. Study sites: 35 to 37v18
  16. Study sites: 33 to 35v17
  17. Study sites: 32 to 33v16
  18. Study sites: 30 to 32v15
  19. Study sites: 28 to 30v14
  20. Study sites: 27 to 28v13
  21. Study sites: 23 to 27v12
  22. Study sites: 22 to 23 Eligibility criteria expanded, about 106 wordsv11 Show 1 more changeShow less
    • Eligibility criteria expanded, about 106 words

    See this version in full on ClinicalTrials.gov ↗

  23. Study sites: 18 to 22v10
  24. Study sites: 16 to 18 Start date changed from estimate of Jul 2021 to Jul 14, 2021v9 Show 1 more changeShow less
    • Start date changed from estimate of Jul 2021 to Jul 14, 2021
  25. Start date: May 2021 to Jul 2021 Study sites: 13 to 16v8 Show 1 more changeShow less
    • Study sites: 13 to 16
  26. Study sites: 9 to 13v7
  27. Study sites: 6 to 9v6
  28. Start date: Feb 2021 to May 2021 Study sites: 3 to 6v5 Show 1 more changeShow less
    • Study sites: 3 to 6
  29. Start date: Nov 2020 to Feb 2021 Study sites: 2 to 3v4 Show 1 more changeShow less
    • Study sites: 2 to 3
  30. Start date: Oct 2020 to Nov 2020 Secondary endpoints revised (7) · Study sites revised (2)v3 Show 2 more changesShow less
    • Secondary endpoints revised (7)
    • Study sites revised (2)

    See this version in full on ClinicalTrials.gov ↗

  31. Study sites: 1 to 2 Start date: Sep 2020 to Oct 2020 · Eligibility criteria expanded, about 127 words · Secondary endpoints: details revised at 7 of 7 entries · 1 morev2 Show 4 more changesShow less
    • Start date: Sep 2020 to Oct 2020
    • Eligibility criteria expanded, about 127 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Study description expanded, about 39 words

    See this version in full on ClinicalTrials.gov ↗

  1. 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.
The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases.
Trial Details
NCT Number NCT04554914
Lead Sponsor Pierre Fabre Medicament
Conditions Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD), EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD), EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD), EBV+ Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders, Allogeneic Hematopoietic Cell Transplant +3 more
Enrollment 190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov