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A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma

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

Record History

The 50 most recent of 75 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 2 of 72 sitesv75
  2. Trial status: Recruiting to Active, Not Recruiting Study sites revised (72)v74 Show 1 more changeShow less
    • Study sites revised (72)

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 2 of 72 sitesv73
  4. Primary and study completion dates: May 1, 2029 to Mar 2027 Study sites: 71 to 72v72 Show 1 more changeShow less
    • Study sites: 71 to 72
  5. Primary completion date: Aug 29, 2027 to May 1, 2029 Study sites: 62 to 71 · Eligibility criteria expanded, about 529 wordsv71 Show 2 more changesShow less
    • Study sites: 62 to 71
    • Eligibility criteria expanded, about 529 words

    See this version in full on ClinicalTrials.gov ↗

Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 56 to 62v70
  2. Study sites: 53 to 56v69
  3. Study sites: 51 to 53v68
  4. Lead sponsor: AbbVie to Genmab Study sites: 50 to 51v67 Show 1 more changeShow less
    • Study sites: 50 to 51
  5. Re-verified, no change to tracked fieldsv66
  6. Site details revised at 1 of 50 sitesv65
  7. Study sites: 49 to 50v64
  8. Study sites revised (49)v63 See this version in full on ClinicalTrials.gov ↗
  9. Study sites: 48 to 49v62
  10. Study sites: 47 to 48v61
  11. Re-verified, no change to tracked fieldsv60
  12. Study sites: 46 to 47v59
  13. Study sites: 45 to 46v58
  14. Study sites revised (45)v57 See this version in full on ClinicalTrials.gov ↗
  15. Study sites: 44 to 45v56
  16. Study sites: 43 to 44v55
  17. Study sites: 42 to 43v54
  18. 2 versions Re-verified since Dec 28, 2023, no change to tracked fieldsv52-v53
  19. Study sites: 41 to 42v51
  20. Re-verified, no change to tracked fieldsv50
  21. Study sites: 39 to 41 Eligibility criteria expanded, about 42 wordsv49 Show 1 more changeShow less
    • Eligibility criteria expanded, about 42 words

    See this version in full on ClinicalTrials.gov ↗

  22. 2 versions Re-verified since Oct 9, 2023, no change to tracked fieldsv47-v48
  23. Study sites: 38 to 39v46
  24. Study sites revised (38)v45 See this version in full on ClinicalTrials.gov ↗
  25. Study sites: 37 to 38v44
  26. Study sites: 36 to 37v43
  27. Re-verified, no change to tracked fieldsv42
  28. Enrollment target: 80 to 184 Study sites: 34 to 36 · Study arms: 1 to 4v41 Show 2 more changesShow less
    • Study sites: 34 to 36
    • Study arms: 1 to 4
  29. Primary completion date: Dec 12, 2023 to Aug 29, 2027 Study sites: 33 to 34 · Completion date: Sep 9, 2025 to May 1, 2029v40 Show 2 more changesShow less
    • Study sites: 33 to 34
    • Completion date: Sep 9, 2025 to May 1, 2029
  30. Study sites: 30 to 33v39
  31. Study sites: 44 to 30v38
  32. Study sites: 43 to 44v37
  33. Site details revised at 1 of 43 sitesv36
  34. Site details revised at 1 of 43 sitesv35
  35. Site details revised at 2 of 43 sitesv34
  36. Site details revised at 1 of 43 sitesv33
  37. Study sites: 41 to 43v32
  38. Site details revised at 1 of 41 sitesv31
  39. Site details revised at 1 of 41 sitesv30
  40. Study sites: 42 to 41v29
  41. Study sites: 41 to 42v28
  42. Study Status, Contacts/Locationsv27
  43. Re-verified, no change to tracked fieldsv26
  • 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.
Genmab
45 trials monitored
See 3 trials at risk
Non-Hodgkin Lymphoma
1,517 trials monitored
See 84 trials at risk
DLBCL
650 trials monitored
See 38 trials at risk
Follicular Lymphoma
313 trials monitored
See 26 trials at risk
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Classic Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) who have received at least 1 prior line of systemic antilymphoma therapy including at least 1 anti-CD20 monoclonal antibody-containing therapy or R/R classic follicular lymphoma (cFL). Adverse events will be assessed. Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R cFL. Study doctors will assess participants in a monotherapy treatment arm of epcoritamab. Participants will receive escalating doses of epcoritamab, until full dose is achieved. Approximately 184 adult participants with R/R DLBCL and R/R cFL will be enrolled in the study in approximately 80 sites in the United States of America. Participants will receive escalating doses of subcutaneous epcoritamab, until full dose is achieved, in 28-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Trial Details
NCT Number NCT05451810
Lead Sponsor Genmab
Collaborators: AbbVie
Conditions Diffuse Large B-Cell Lymphoma, Classic Follicular Lymphoma
Enrollment 184 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov