A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma

Study acronym: LEDA
StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Site details revised at 1 of 30 sitesv29
  2. Study completion date: Jan 26, 2031 to Feb 20, 2031v28
  3. Study sites: 31 to 30v27
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 108 to confirmed 109
    • Study sites: 36 to 31
    • Study completion date: Jan 18, 2031 to Jan 26, 2031
    v26
  5. Site details revised at 6 of 36 sitesv25
Show 23 earlier versionsHide 23 earlier versions
  1. Secondary endpoints: 9 to 8v24
  2. Study sites: 35 to 36v23
  3. Primary completion date: Jul 24, 2028 to Jul 25, 2028
    • Site details revised at 5 of 35 sites
    v22
  4. Study sites: 33 to 35v21
  5. Study sites: 32 to 33v20
  6. Study sites: 29 to 32v19
  7. Study sites: 28 to 29v18
  8. Study sites: 27 to 28
    • Study completion date: Feb 7, 2029 to Jan 18, 2031
    v17
  9. Study sites: 25 to 27v16
  10. Study sites: 24 to 25v15
  11. Study sites: 23 to 24v14
  12. Study sites: 19 to 23v13
  13. Study sites: 15 to 19v12
  14. Study sites: 14 to 15v11
  15. Study sites: 12 to 14v10
  16. Study sites: 11 to 12v9
  17. Study sites: 9 to 11v8
  18. Study sites: 7 to 9v7
  19. Re-verified, no change to tracked fieldsv6
  20. Study sites: 1 to 7
    • Primary completion date: Jul 6, 2028 to Jul 24, 2028
    • Study completion date: Jan 21, 2029 to Feb 7, 2029
    v5
  21. Start date changed from estimate of Sep 15, 2023 to Oct 2, 2023v4
  22. Start date: Aug 10, 2023 to Sep 15, 2023
    • Primary completion date: May 31, 2028 to Jul 6, 2028
    • Study completion date: Dec 16, 2028 to Jan 21, 2029
    v3
  23. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • 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.
This trial will compare tisagenlecleucel to standard of care in adult participants with relapsed or refractory (r/r) follicular lymphoma.
Trial Details
NCT Number NCT05888493
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 Follicular Lymphoma (FL)
Related terms Lymphoma, Follicular, Recurrence
Enrollment 109 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov