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A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 30 days later Sep 24, 2024 → Oct 24, 2024
See other at-risk trials from Roche/Genentech

Record History

  1. Primary completion pushed from Sep 24, 2024 to Oct 24, 2024 Completion date: Sep 30, 2026 to Oct 15, 2026 · Eligibility criteria expanded, about 19 words · Site details revised at 5 of 20 sites · 1 more Show 4 more changesShow less
    • Completion date: Sep 30, 2026 to Oct 15, 2026
    • Eligibility criteria expanded, about 19 words
    • Site details revised at 5 of 20 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary completion moved earlier from Sep 30, 2026 to Sep 24, 2024 Results first posted: Aug 18, 2026 · Site details revised at 5 of 20 sitesv42 Show 2 more changesShow less
    • Results first posted: Aug 18, 2026
    • Site details revised at 5 of 20 sites
  3. Study sites: 18 to 20 Secondary endpoints revised (7)v41 Show 1 more changeShow less
    • Secondary endpoints revised (7)

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv40
  5. Primary completion date: Oct 24, 2024 to Sep 30, 2026 Study sites: 23 to 18v39 Show 1 more changeShow less
    • Study sites: 23 to 18
Show 37 earlier versionsHide 37 earlier versions
  1. Re-verified, no change to tracked fieldsv38
  2. Study sites: 25 to 23 Primary completion date changed from estimate of Jun 1, 2025 to Oct 24, 2024 · Completion date: Jun 1, 2025 to Sep 30, 2026v37 Show 2 more changesShow less
    • Primary completion date changed from estimate of Jun 1, 2025 to Oct 24, 2024
    • Completion date: Jun 1, 2025 to Sep 30, 2026
  3. Study sites: 27 to 25v36
  4. Study sites: 28 to 27v35
  5. Re-verified, no change to tracked fieldsv34
  6. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 40 to confirmed 46 · Site details revised at 28 of 28 sitesv33 Show 2 more changesShow less
    • Enrollment target: estimated 40 to confirmed 46
    • Site details revised at 28 of 28 sites
  7. Site details revised at 6 of 28 sitesv32
  8. Site details revised at 4 of 28 sitesv31
  9. Site details revised at 1 of 28 sitesv30
  10. Site details revised at 3 of 28 sitesv29
  11. Site details revised at 4 of 28 sitesv28
  12. Site details revised at 2 of 28 sitesv27
  13. Eligibility criteria expanded, about 4 wordsv26 See this version in full on ClinicalTrials.gov ↗
  14. Study sites: 26 to 28v25
  15. Study sites: 25 to 26v24
  16. Study sites: 24 to 25v23
  17. Site details revised at 3 of 24 sitesv22
  18. Re-verified, no change to tracked fieldsv21
  19. Site details revised at 2 of 24 sitesv20
  20. Site details revised at 1 of 24 sitesv19
  21. Site details revised at 10 of 24 sitesv18
  22. Site details revised at 10 of 24 sitesv17
  23. Site details revised at 9 of 24 sitesv16
  24. Study sites: 20 to 24v15
  25. Study sites revised (20)v14 See this version in full on ClinicalTrials.gov ↗
  26. Study sites: 18 to 20v13
  27. Site details revised at 1 of 18 sitesv12
  28. Study sites: 16 to 18v11
  29. Study sites: 14 to 16v10
  30. Site details revised at 1 of 14 sitesv9
  31. Study sites: 12 to 14v8
  32. Study sites: 8 to 12 Primary and study completion dates: Dec 10, 2024 to Jun 1, 2025 · Start date changed from estimate of Apr 30, 2022 to Mar 22, 2022v7 Show 2 more changesShow less
    • Primary and study completion dates: Dec 10, 2024 to Jun 1, 2025
    • Start date changed from estimate of Apr 30, 2022 to Mar 22, 2022
  33. Study sites: 7 to 8v6
  34. Start date: Jan 5, 2022 to Apr 30, 2022 Study sites: 1 to 7v5 Show 1 more changeShow less
    • Study sites: 1 to 7
  35. Trial status: Not Yet Recruiting to Recruiting Study sites: 22 to 1v4 Show 1 more changeShow less
    • Study sites: 22 to 1
  36. Re-verified, no change to tracked fieldsv3
  37. Start date: Aug 31, 2021 to Jan 5, 2022 Study sites: 8 to 22 · Eligibility criteria revisedv2 Show 2 more changesShow less
    • Study sites: 8 to 22
    • Eligibility criteria revised

    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.
Roche/Genentech
366 trials monitored
See 33 trials at risk
This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in individuals with circulating tumor DNA (ctDNA) high-risk diffuse large B-cell lymphoma (DLBCL), as the first line of treatment.
Trial Details
NCT Number NCT04980222
Lead Sponsor Hoffmann-La Roche
Conditions Lymphoma
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov