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A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL

Study acronym: SEQUOIA
StatusActive, Not Recruiting
PhasePhase 3
SponsorBeiGene
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion date: Sep 2026 to Oct 31, 2027v39
  2. Study sites: 179 to 158v38
  3. Re-verified, no change to tracked fieldsv37
  4. Results first posted: Nov 7, 2023 Primary completion date: Oct 31, 2022 to May 7, 2021 · Primary endpoint revised · Enrollment target: estimated 740 to confirmed 590 · 3 morev36 Show 6 more changesShow less
    • Primary completion date: Oct 31, 2022 to May 7, 2021
    • Primary endpoint revised
    • Enrollment target: estimated 740 to confirmed 590
    • Study sites: 160 to 179
    • Start date: Nov 2, 2017 to Oct 31, 2017
    • Secondary endpoints: 21 to 20

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: May 31, 2022 to Oct 31, 2022 Completion date: Oct 31, 2024 to Sep 2026 · Eligibility criteria revisedv35 Show 2 more changesShow less
    • Completion date: Oct 31, 2024 to Sep 2026
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

Show 33 earlier versionsHide 33 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Primary completion date changed from estimate of May 2022 to May 31, 2022 · Completion date: Oct 2022 to Oct 31, 2024 · Site details revised at 160 of 160 sitesv34 Show 3 more changesShow less
    • Primary completion date changed from estimate of May 2022 to May 31, 2022
    • Completion date: Oct 2022 to Oct 31, 2024
    • Site details revised at 160 of 160 sites
  2. Enrollment target: 710 to 740 Primary completion date: Jan 2022 to May 2022 · Site details revised at 2 of 160 sitesv33 Show 2 more changesShow less
    • Primary completion date: Jan 2022 to May 2022
    • Site details revised at 2 of 160 sites
  3. Primary completion date: Oct 2021 to Jan 2022v32
  4. Site details revised at 2 of 160 sitesv31
  5. Enrollment target: 680 to 710 Site details revised at 3 of 160 sitesv30 Show 1 more changeShow less
    • Site details revised at 3 of 160 sites
  6. Secondary endpoints: details revised at 11 of 21 entries Study sites revised (160)v29 Show 1 more changeShow less
    • Study sites revised (160)

    See this version in full on ClinicalTrials.gov ↗

  7. Secondary endpoints: details revised at 11 of 21 entries Site details revised at 24 of 160 sites · Publications: details revised at 1 of 9 entriesv28 Show 2 more changesShow less
    • Site details revised at 24 of 160 sites
    • Publications: details revised at 1 of 9 entries
  8. Primary endpoint revised Enrollment target: 600 to 680 · Eligibility criteria expanded, about 16 words · Secondary endpoints: 15 to 21 · 3 morev27 Show 6 more changesShow less
    • Enrollment target: 600 to 680
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: 15 to 21
    • Study description revised
    • Study title revised
    • Study arms: 4 to 6

    See this version in full on ClinicalTrials.gov ↗

  9. Publications: 8 to 9v26 See this version in full on ClinicalTrials.gov ↗
  10. Primary completion date: Sep 2020 to Oct 2021 Site details revised at 16 of 160 sitesv25 Show 1 more changeShow less
    • Site details revised at 16 of 160 sites
  11. Site contacts updated at 21 of 160 sitesv24
  12. Re-verified, no change to tracked fieldsv23
  13. Trial status: Active, Not Recruiting to Recruiting Primary endpoint revised · Enrollment target: 550 to 600 · Interventions: BGB-3111 (Drug), Bendamustine (Drug), Rituximab (Drug) to Bendamustine (Drug), Rituximab (Drug), Venetoclax (Drug), Zanubrutinib (Drug) · 5 morev22 Show 8 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 550 to 600
    • Interventions: BGB-3111 (Drug), Bendamustine (Drug), Rituximab (Drug) to Bendamustine (Drug), Rituximab (Drug), Venetoclax (Drug), Zanubrutinib (Drug)
    • Eligibility criteria shortened, about 27 words
    • Secondary endpoints: 9 to 15
    • Study description expanded, about 15 words
    • Site details revised at 160 of 160 sites
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  14. Re-verified, no change to tracked fieldsv21
  15. Trial status: Recruiting to Active, Not Recruiting Study sites: 163 to 160v20 Show 1 more changeShow less
    • Study sites: 163 to 160
  16. Study sites: 200 to 163v19
  17. Study sites: 198 to 200v18
  18. Study sites: 187 to 198v17
  19. Site details revised at 2 of 187 sitesv16
  20. Study sites: 186 to 187v15
  21. Study sites: 187 to 186v14
  22. Site details revised at 1 of 187 sitesv13
  23. Study sites: 162 to 187v12
  24. Enrollment target: 467 to 550 Study sites: 156 to 162v11 Show 1 more changeShow less
    • Study sites: 156 to 162
  25. Re-verified, no change to tracked fieldsv10
  26. Study sites: 154 to 156v9
  27. Re-verified, no change to tracked fieldsv8
  28. Study sites: 52 to 154v7
  29. Study sites: 13 to 52v6
  30. Re-verified, no change to tracked fieldsv5
  31. Study sites: 4 to 13v4
  32. Study sites: 2 to 4v3
  33. Study sites revised (2)v2 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.
To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review.
Trial Details
NCT Number NCT03336333
Lead Sponsor BeiGene
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 590 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov