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A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

Study acronym: EPCORE DLBCL-2
StatusActive, Not Recruiting
PhasePhase 3
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 185 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Study sites revised (331)v185 See this version in full on ClinicalTrials.gov ↗
  2. Trial status: Recruiting to Active, Not Recruiting Study sites revised (331)v184 Show 1 more changeShow less
    • Study sites revised (331)

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 329 to 331v183
  4. Primary completion date: Sep 24, 2028 to Jun 2027 Study sites: 319 to 329 · Completion date: Dec 30, 2029 to Dec 2029v182 Show 2 more changesShow less
    • Study sites: 319 to 329
    • Completion date: Dec 30, 2029 to Dec 2029
  5. Study sites: 317 to 319v181
Show 45 earlier versionsHide 45 earlier versions
  1. Primary completion date: Aug 20, 2026 to Sep 24, 2028v180
  2. Primary completion date: Jan 24, 2025 to Aug 20, 2026 Study sites: 301 to 317v179 Show 1 more changeShow less
    • Study sites: 301 to 317
  3. Primary completion date: Jan 31, 2027 to Jan 24, 2025 Study sites: 285 to 301 · Collaborators shortened, about 1 wordv178 Show 2 more changesShow less
    • Study sites: 285 to 301
    • Collaborators shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Lead sponsor: AbbVie to Genmab Study sites: 263 to 285v177 Show 1 more changeShow less
    • Study sites: 263 to 285
  5. Study sites: 262 to 263v176
  6. Study sites: 259 to 262v175
  7. Study sites: 256 to 259v174
  8. Study sites: 255 to 256v173
  9. Study sites: 254 to 255v172
  10. Study sites revised (254)v171 See this version in full on ClinicalTrials.gov ↗
  11. Study sites: 251 to 254 Completion date: May 13, 2030 to Dec 30, 2029v170 Show 1 more changeShow less
    • Completion date: May 13, 2030 to Dec 30, 2029
  12. Study sites: 248 to 251v169
  13. Study sites: 247 to 248v168
  14. Study sites: 246 to 247v167
  15. Completion date: Jun 11, 2030 to May 13, 2030 Study sites revised (246)v166 Show 1 more changeShow less
    • Study sites revised (246)

    See this version in full on ClinicalTrials.gov ↗

  16. Study sites revised (246)v165 See this version in full on ClinicalTrials.gov ↗
  17. Study sites: 245 to 246v164
  18. Study sites: 241 to 245v163
  19. Study sites: 239 to 241v162
  20. Study sites: 236 to 239v161
  21. Study sites: 235 to 236v160
  22. Study sites: 234 to 235v159
  23. Study sites: 232 to 234v158
  24. Study sites: 230 to 232v157
  25. Study sites: 228 to 230v156
  26. Study sites revised (228)v155 See this version in full on ClinicalTrials.gov ↗
  27. Study sites: 227 to 228v154
  28. Study sites revised (227)v153 See this version in full on ClinicalTrials.gov ↗
  29. Study sites: 226 to 227v152
  30. Study sites: 224 to 226v151
  31. Re-verified, no change to tracked fieldsv150
  32. Study sites: 222 to 224v149
  33. Study sites: 217 to 222v148
  34. Study sites: 216 to 217v147
  35. Study sites revised (216)v146 See this version in full on ClinicalTrials.gov ↗
  36. Study sites: 215 to 216v145
  37. Study sites: 213 to 215v144
  38. Study sites: 212 to 213v143
  39. Study sites: 210 to 212v142
  40. Study sites: 208 to 210v141
  41. Study sites: 207 to 208v140
  42. Study sites: 205 to 207v139
  43. Study sites: 204 to 205v138
  44. Re-verified, no change to tracked fieldsv137
  45. Study sites: 203 to 204v136
  • 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
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally. In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-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 NCT05578976
Lead Sponsor Genmab
Conditions Diffuse Large B-Cell Lymphoma
Enrollment 900 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov