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Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

Study acronym: EPCORE™ CLL-1
StatusActive, Not Recruiting
PhasePhase 1/2
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 4 entries Eligibility criteria expanded, about 50 words · Secondary endpoints: details revised at 4 of 20 entries · Site details revised at 20 of 81 sites · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 50 words
    • Secondary endpoints: details revised at 4 of 20 entries
    • Site details revised at 20 of 81 sites
    • Publications: details revised at 1 of 1 entry
  2. Site details revised at 1 of 81 sitesv44
  3. Re-verified, no change to tracked fieldsv43
  4. Study sites: 83 to 81v42
  5. Enrollment target: 195 to 194v41
Show 39 earlier versionsHide 39 earlier versions
  1. Re-verified, no change to tracked fieldsv40
  2. Site details revised at 17 of 83 sitesv39
  3. Primary completion date: Feb 2028 to Dec 2027 Completion date: Apr 2028 to Feb 2028v38 Show 1 more changeShow less
    • Completion date: Apr 2028 to Feb 2028
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 424 to confirmed 195 · Study sites: 87 to 83v37 Show 2 more changesShow less
    • Enrollment target: estimated 424 to confirmed 195
    • Study sites: 87 to 83
  5. Re-verified, no change to tracked fieldsv36
  6. Primary completion date: Jun 2029 to Feb 2028 Completion date: Aug 2029 to Apr 2028v35 Show 1 more changeShow less
    • Completion date: Aug 2029 to Apr 2028
  7. Site details revised at 6 of 87 sitesv34
  8. 2 versions Re-verified since Oct 7, 2025, no change to tracked fieldsv32-v33
  9. Site details revised at 17 of 87 sitesv31
  10. Site details revised at 4 of 87 sites Eligibility criteria expanded, about 4 words · Study description expanded, about 4 wordsv30 Show 2 more changesShow less
    • Eligibility criteria expanded, about 4 words
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 77 to 87v29
  12. Re-verified, no change to tracked fieldsv28
  13. Enrollment target: 304 to 424 Eligibility criteria shortened, about 62 words · Secondary endpoints: 21 to 20 · Study description expanded, about 5 wordsv27 Show 3 more changesShow less
    • Eligibility criteria shortened, about 62 words
    • Secondary endpoints: 21 to 20
    • Study description expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  14. Enrollment target: 184 to 304 Primary endpoints revised (4) · Interventions: Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Lenalidomide (Drug), Venetoclax (Drug), rituximab… to Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological)… · Eligibility criteria expanded, about 353 words · 5 morev26 Show 8 more changesShow less
    • Primary endpoints revised (4)
    • Interventions: Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Lenalidomide (Drug), Venetoclax (Drug), rituximab… to Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological)…
    • Eligibility criteria expanded, about 353 words
    • Secondary endpoints: 22 to 21
    • Study description expanded, about 27 words
    • Study sites revised (77)
    • Collaborators: 1 to 2
    • Study arms: 5 to 7

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 76 to 77v25
  16. 6 versions Re-verified since Jul 8, 2024, no change to tracked fieldsv19-v24
  17. Study sites: 75 to 76v18
  18. Study sites: 68 to 75v17
  19. Study sites revised (68)v16 See this version in full on ClinicalTrials.gov ↗
  20. Study sites: 52 to 68v15
  21. 2 versions Re-verified since Jan 2, 2024, no change to tracked fieldsv13-v14
  22. Study sites: 29 to 52v12
  23. Study sites: 28 to 29v11
  24. Re-verified, no change to tracked fieldsv10
  25. Enrollment target: 102 to 184 Primary completion date: Aug 2024 to Jun 2029 · Primary endpoints: 3 to 4 · Study sites: 24 to 28 · 8 morev9 Show 11 more changesShow less
    • Primary completion date: Aug 2024 to Jun 2029
    • Primary endpoints: 3 to 4
    • Study sites: 24 to 28
    • Completion date: Aug 2026 to Aug 2029
    • Start date: Nov 30, 2020 to Nov 25, 2020
    • Interventions: Epcoritamab (Biological) to Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Lenalidomide (Drug), Venetoclax (Drug), rituximab…
    • Eligibility criteria shortened, about 24 words
    • Secondary endpoints: 20 to 22
    • Study description expanded, about 26 words
    • Study title revised
    • Study arms: 2 to 5

    See this version in full on ClinicalTrials.gov ↗

  26. Study sites: 23 to 24v8
  27. Re-verified, no change to tracked fieldsv7
  28. Study sites: 21 to 23v6
  29. Study sites: 19 to 21v5
  30. Enrollment target: 32 to 102 Primary completion date: Dec 2022 to Aug 2024 · Primary endpoints: 4 to 3 · Completion date: Dec 2024 to Aug 2026 · 6 morev4 Show 9 more changesShow less
    • Primary completion date: Dec 2022 to Aug 2024
    • Primary endpoints: 4 to 3
    • Completion date: Dec 2024 to Aug 2026
    • Eligibility criteria shortened, about 27 words
    • Secondary endpoints: 19 to 20
    • Study sites revised (19)
    • Study arms: 1 to 2
    • Study description expanded, about 5 words
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  31. Study sites: 10 to 19v3
  32. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 2020 to Nov 30, 2020 · Site details revised at 10 of 10 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Nov 2020 to Nov 30, 2020
    • Site details revised at 10 of 10 sites
  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.
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will be tested either in Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) as: * Monotherapy, or * Combination therapy: * epcoritamab + venetoclax * epcoritamab + pirtobrutinib In Non-United States (US) Participants Only: Treatment-naïve (TN) high risk (HR) (CLL): • epcoritamab + pirtobrutinib Combination therapy for Richter's Syndrome (RS): * epcoritamab + lenalidomide * epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine \[Oncovin®\] and prednisone). The study includes participants with R/R or TN HR CLL (non-US participants only)/small lymphocytic lymphoma (SLL) and participants with RS. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Participants with RS are only included in the expansion phase. Epcoritamab will be injected subcutaneously (under the skin). Standard-of-care and combination treatments (venetoclax, pirtobrutinib, lenalidomide, and R-CHOP) will be given either orally (by mouth) or intravenously (in a vein). Study details include: * Study duration will be up to 5 years after the last participant's first treatment in the trial. * The treatment duration for each participant will be between 12 months (1 year) and 24 months (2 years), depending upon the treatment arm assigned. * The visit frequency will be either weekly, every other week, or monthly, depending upon the part of the study. All participants will receive active drug; no one will be given placebo.
Trial Details
NCT Number NCT04623541
Lead Sponsor Genmab
Collaborators: AbbVie, Eli Lilly and Company
Conditions Relapsed/Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome, Treatment-naïve High Risk Chronic Lymphocytic Leukemia
Enrollment 194 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov