A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma

Study acronym: GLOBRYTE
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Minor Study sites: 82 to 83
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 2 of 16 entries
  2. Re-verified, no change to tracked fieldsv38
  3. Minor Trial sites expanded: 77 → 82 locationsv37
  4. Minor Study sites: 76 to 77v36
  5. Study Status, Contacts/Locations, Referencesv35
Show 33 earlier versionsHide 33 earlier versions
  1. Minor Study sites: 75 to 76v34
  2. Minor Site details revised at 1 of 75 sitesv33
  3. Re-verified, no change to tracked fieldsv32
  4. Notable Primary completion date: Feb 26, 2027 to Aug 31, 2027
    • Study completion date: Sep 30, 2027 to Mar 31, 2028
    v31
  5. Minor Eligibility criteria expanded, about 6 words
    • Site details revised at 2 of 75 sites
    v30
  6. 2 versions Re-verified since Nov 3, 2025, no change to tracked fieldsv28-v29
  7. Minor Site details revised at 1 of 75 sitesv27
  8. Minor Study sites: 74 to 75v26
  9. Minor Primary completion date: Nov 30, 2026 to Feb 26, 2027
    • Study completion date: Jun 30, 2027 to Sep 30, 2027
    • Site details revised at 2 of 74 sites
    v25
  10. Minor Site details revised at 1 of 74 sitesv24
  11. Re-verified, no change to tracked fieldsv23
  12. Notable Primary completion date: Mar 31, 2026 to Nov 30, 2026
    • Study sites: 73 to 74
    v22
  13. Minor Study sites: 72 to 73v21
  14. Minor Study sites: 71 to 72v20
  15. Minor Study sites: 69 to 71
    • Study completion date: Dec 31, 2026 to Jun 30, 2027
    v19
  16. Minor Study sites: 62 to 69
    • Primary completion date: Feb 2, 2026 to Mar 31, 2026
    v18
  17. 2 versions Re-verified since Nov 6, 2024, no change to tracked fieldsv16-v17
  18. Minor Study sites: 61 to 62v15
  19. Minor Site details revised at 2 of 61 sitesv14
  20. Minor Study sites: 59 to 61v13
  21. Minor Study sites: 56 to 59v12
  22. Minor Study sites: 52 to 56v11
  23. Minor Study sites: 49 to 52v10
  24. Minor Study sites: 45 to 49v9
  25. Minor Study sites: 41 to 45v8
  26. Minor Study sites: 35 to 41v7
  27. Minor Study sites: 30 to 35v6
  28. Minor Study sites: 26 to 30v5
  29. Minor Study sites: 23 to 26v4
  30. Minor Study sites: 10 to 23v3
  31. Minor Study sites: 3 to 10
    • Start date changed from estimate of Oct 13, 2023 to Oct 22, 2023
    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.
369 trials monitored
See 29 trials at risk
The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).
Trial Details
NCT Number NCT06084936
Lead Sponsor Hoffmann-La Roche
Conditions
(from sponsor)
Lymphoma
Related terms Lymphoma
Enrollment 182 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov