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Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since May 22, 2026, no change to tracked fieldsv43-v44
  2. Study sites: 131 to 130v42
  3. 7 versions Re-verified since May 10, 2024, no change to tracked fieldsv35-v41
  4. Site details revised at 1 of 131 sitesv34
  5. Primary endpoint revised Completion date: Oct 16, 2026 to Jan 3, 2028 · Interventions: ACP-196 (Drug), ibrutinib (Drug) to Acalabrutinib (Drug), Ibrutinib (Drug) · Eligibility criteria expanded, about 28 words · 2 morev33 Show 5 more changesShow less
    • Completion date: Oct 16, 2026 to Jan 3, 2028
    • Interventions: ACP-196 (Drug), ibrutinib (Drug) to Acalabrutinib (Drug), Ibrutinib (Drug)
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: 1 to 10
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

Show 31 earlier versionsHide 31 earlier versions
  1. 2 versions Re-verified since Mar 14, 2023, no change to tracked fieldsv31-v32
  2. Completion date: Sep 28, 2027 to Oct 16, 2026v30
  3. Completion date: Aug 31, 2027 to Sep 28, 2027v29
  4. Study sites: 132 to 131 Completion date: Mar 31, 2022 to Aug 31, 2027v28 Show 1 more changeShow less
    • Completion date: Mar 31, 2022 to Aug 31, 2027
  5. Results first posted: Jan 28, 2022 Primary endpoint revised · Completion date: Nov 1, 2021 to Mar 31, 2022 · Start date: Sep 17, 2015 to Jul 28, 2015 · 2 morev27 Show 5 more changesShow less
    • Primary endpoint revised
    • Completion date: Nov 1, 2021 to Mar 31, 2022
    • Start date: Sep 17, 2015 to Jul 28, 2015
    • Secondary endpoints: 4 to 1
    • Site details revised at 3 of 132 sites

    See this version in full on ClinicalTrials.gov ↗

  6. Primary completion date changed from estimate of Jun 30, 2022 to Sep 15, 2020 Completion date: Jun 30, 2022 to Nov 1, 2021v26 Show 1 more changeShow less
    • Completion date: Jun 30, 2022 to Nov 1, 2021
  7. Site details revised at 15 of 132 sitesv25
  8. Primary and study completion dates: Mar 2021 to Jun 30, 2022 Study sites: 160 to 132 · Start date: Oct 2015 to Sep 17, 2015v24 Show 2 more changesShow less
    • Study sites: 160 to 132
    • Start date: Oct 2015 to Sep 17, 2015
  9. Primary completion date: Jun 2019 to Mar 2021 Start date: Jun 2015 to Oct 2015 · Completion date: Dec 2020 to Mar 2021v23 Show 2 more changesShow less
    • Start date: Jun 2015 to Oct 2015
    • Completion date: Dec 2020 to Mar 2021
  10. Re-verified, no change to tracked fieldsv22
  11. Completion date: Dec 2020 Study sites revised (160) · Study title shortened, about 5 wordsv21 Show 2 more changesShow less
    • Study sites revised (160)
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  12. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 500 to confirmed 533 · Study sites revised (160)v20 Show 2 more changesShow less
    • Enrollment target: estimated 500 to confirmed 533
    • Study sites revised (160)

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites: 3 to 160v19
  14. 3 versions Re-verified since Jul 29, 2016, no change to tracked fieldsv16-v18
  15. Study sites: 2 to 3 Eligibility criteria shortened, about 12 wordsv15 Show 1 more changeShow less
    • Eligibility criteria shortened, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  16. Re-verified, no change to tracked fieldsv14
  17. Primary completion date: Jun 2018 to Jun 2019 Study sites: 1 to 2 · Study title expanded, about 1 wordv13 Show 2 more changesShow less
    • Study sites: 1 to 2
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  18. 3 versions Re-verified since Feb 3, 2016, no change to tracked fieldsv10-v12
  19. Study title expanded, about 3 wordsv9 See this version in full on ClinicalTrials.gov ↗
  20. 6 versions Re-verified since Jul 29, 2015, no change to tracked fieldsv3-v8
  21. Trial status: Not Yet Recruiting to Recruiting Start date: Jul 2015 to Jun 2015 · Site details revisedv2 Show 2 more changesShow less
    • Start date: Jul 2015 to Jun 2015
    • Site details revised
  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.
This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.
Trial Details
NCT Number NCT02477696
Lead Sponsor Acerta Pharma BV
Conditions Chronic Lymphocytic Leukemia
Enrollment 533 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov