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An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv28
  2. Completion date: Sep 9, 2026 to Sep 6, 2026v27
  3. Completion date: Sep 6, 2026 to Sep 9, 2026v26
  4. 5 versions Re-verified since Nov 25, 2024, no change to tracked fieldsv21-v25
  5. Completion date: Sep 1, 2026 to Sep 6, 2026v20
Show 18 earlier versionsHide 18 earlier versions
  1. Re-verified, no change to tracked fieldsv19
  2. Completion date: Dec 31, 2025 to Sep 1, 2026 Site details revised at 1 of 58 sitesv18 Show 1 more changeShow less
    • Site details revised at 1 of 58 sites
  3. 6 versions Re-verified since Jan 12, 2022, no change to tracked fieldsv12-v17
  4. Site details revised at 9 of 58 sitesv11
  5. Primary completion date: Feb 2017 to Dec 4, 2020 Study sites: 2 to 58 · Completion date: Sep 2021 to Dec 31, 2025 · Start date: Mar 2015 to Mar 2, 2015 · 1 morev10 Show 4 more changesShow less
    • Study sites: 2 to 58
    • Completion date: Sep 2021 to Dec 31, 2025
    • Start date: Mar 2015 to Mar 2, 2015
    • Study description expanded, about 159 words

    See this version in full on ClinicalTrials.gov ↗

  6. Completion date: Sep 2019 to Sep 2021v9
  7. Re-verified, no change to tracked fieldsv8
  8. Results first posted: Oct 19, 2018 Primary endpoint revisedv7 Show 1 more changeShow less
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  9. Start date: Sep 2014 to Mar 2015 Primary completion date changed from estimate of Mar 2017 to Feb 2017 · Completion date: Jan 2018 to Sep 2019v6 Show 2 more changesShow less
    • Primary completion date changed from estimate of Mar 2017 to Feb 2017
    • Completion date: Jan 2018 to Sep 2019
  10. Primary endpoint revised Enrollment target: estimated 117 to confirmed 124 · Primary completion date: Oct 2016 to Mar 2017 · Interventions: ACP-196 (Drug) to ACP-196 (acalabrutinib) (Drug) · 2 morev5 Show 5 more changesShow less
    • Enrollment target: estimated 117 to confirmed 124
    • Primary completion date: Oct 2016 to Mar 2017
    • Interventions: ACP-196 (Drug) to ACP-196 (acalabrutinib) (Drug)
    • Study title revised
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. Trial status: Recruiting to Active, Not Recruiting Study sites revised (2)v4 Show 1 more changeShow less
    • Study sites revised (2)

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  12. Primary completion date: Nov 2015 to Oct 2016 Primary endpoint revised · Enrollment target: 120 to 117 · Study sites: 4 to 2 · 3 morev3 Show 6 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 120 to 117
    • Study sites: 4 to 2
    • Completion date: Jan 2018
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints shortened, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  13. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 80 to 120 · Study sites revised (4)v2 Show 2 more changesShow less
    • Enrollment target: 80 to 120
    • Study sites revised (4)

    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.
The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).
Trial Details
NCT Number NCT02213926
Lead Sponsor Acerta Pharma BV
Conditions Mantle Cell Lymphoma (MCL)
Enrollment 124 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov