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A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma

StatusActive, Not Recruiting
PhasePhase 1/2
SponsorGenmab
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later Apr 2025 → Sep 2026
See other at-risk trials from Genmab

Record History

  1. Notable Primary and study completion pushed from Apr 2025 to Sep 2026v34
  2. Minor Re-verified, no change to tracked fieldsv33
  3. Minor Primary and study completion dates: Apr 15, 2025 to Apr 2025v32
  4. Minor 3 versions Re-verified since Sep 2, 2024, no change to tracked fieldsv29-v31
  5. Minor Primary and study completion dates: Dec 13, 2024 to Apr 15, 2025v28
Show 26 earlier versionsHide 26 earlier versions
  1. Notable Phase: Phase 1 to Phase 1/2v27
  2. Minor 2 versions Re-verified since Jun 3, 2024, no change to tracked fieldsv25-v26
  3. Notable Lead sponsor: AbbVie to Genmab Collaborator revisedv24 Show 1 more changeShow less
  4. Notable Primary and study completion dates: Jan 25, 2024 to Dec 13, 2024 Study sites revised (18)v23 Show 1 more changeShow less
  5. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 66 to confirmed 49 · Site details revised at 18 of 18 sitesv22 Show 2 more changesShow less
    • Enrollment target: estimated 66 to confirmed 49
    • Site details revised at 18 of 18 sites
  6. Minor Re-verified, no change to tracked fieldsv21
  7. Minor Primary and study completion dates: Jan 15, 2024 to Jan 25, 2024 Eligibility criteria expanded, about 138 wordsv20 Show 1 more changeShow less
    • Eligibility criteria expanded, about 138 words

    See this version in full on ClinicalTrials.gov ↗

  8. Minor 2 versions Re-verified since Feb 3, 2023, no change to tracked fieldsv18-v19
  9. Minor Site details revised at 3 of 18 sitesv17
  10. Minor Re-verified, no change to tracked fieldsv16
  11. Minor Study sites: 19 to 18v15
  12. Minor Site details revised at 1 of 19 sitesv14
  13. Minor Site details revised at 2 of 19 sitesv13
  14. Minor Site details revised at 1 of 19 sitesv12
  15. Minor Site details revised at 2 of 19 sitesv11
  16. Minor Site details revised at 1 of 19 sitesv10
  17. Minor Site details revised at 1 of 19 sitesv9
  18. Minor Site details revised at 1 of 19 sitesv8
  19. Minor Site details revised at 1 of 19 sitesv7
  20. Minor Study sites: 21 to 19v6
  21. Minor Site details revised at 1 of 21 sitesv5
  22. Minor Site details revised at 1 of 21 sitesv4
  23. Notable Primary endpoints revised (2) Primary and study completion dates: Dec 11, 2023 to Jan 15, 2024 · Eligibility criteria expanded, about 274 words · Secondary endpoints: 12 to 5 · 1 morev3 Show 4 more changesShow less
    • Primary and study completion dates: Dec 11, 2023 to Jan 15, 2024
    • Eligibility criteria expanded, about 274 words
    • Secondary endpoints: 12 to 5
    • Site details revised at 2 of 21 sites

    See this version in full on ClinicalTrials.gov ↗

  24. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 22 to 21 · Start date changed from estimate of Mar 14, 2022 to Mar 10, 2022 · Eligibility criteria shortened, about 2 wordsv2 Show 3 more changesShow less
    • Study sites: 22 to 21
    • Start date changed from estimate of Mar 14, 2022 to Mar 10, 2022
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  1. Minor 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.
45 trials monitored
See 3 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 safety and toxicity of epcoritamab as a monotherapy and when combined with standard of care therapy \[Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or Rituximab and lenalidomide (R2)\] in adult participants in China with B-Cell Non-Hodgkin Lymphoma. Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of B-Cell Non-Hodgkin Lymphoma. Study doctors put the participants in groups called treatment arms. A monotherapy of epcoritamab and two different combination of epcoritamab with standard of care therapy (R-CHOP or R2) will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. Approximately 66 adult participants with B-Cell Non-Hodgkin Lymphoma will be enrolled in the study in approximately 21 sites in China. In the monotherapy arm (Cohort 1), participants will receive subcutaneous epcoritamab in 28-day cycles. In the combination arms (Cohorts 2 and 3), participants in Cohort 2 will receive subcutaneous epcoritamab with standard of care therapy (R-CHOP) in 21-day cycles followed by 28-day cycles, participants in Cohort 3 will receive subcutaneous epcoritamab with standard of care therapy (R2) 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 NCT05201248
Lead Sponsor Genmab
Collaborators: AbbVie
Conditions B-Cell Non-Hodgkin Lymphoma
Enrollment 49 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov