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An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia

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

Record History

  1. 5 versions Re-verified since Oct 9, 2025, no change to tracked fieldsv21-v25
  2. Start date: Sep 8, 2014 to Sep 11, 2014v20
  3. 6 versions Re-verified since May 9, 2023, no change to tracked fieldsv14-v19
  4. Primary endpoints: 1 to 2 Enrollment target: 106 to 107 · Interventions: Acalabrutinib (ACP-196) (Drug) to Acalabrutinib (ACP-196) (Drug), Acalabrutinib (ACP-196) (Drug) · Secondary endpoints: details revised at 2 of 3 entries · 1 morev13 Show 4 more changesShow less
    • Enrollment target: 106 to 107
    • Interventions: Acalabrutinib (ACP-196) (Drug) to Acalabrutinib (ACP-196) (Drug), Acalabrutinib (ACP-196) (Drug)
    • Secondary endpoints: details revised at 2 of 3 entries
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv12
Show 10 earlier versionsHide 10 earlier versions
  1. Completion date: Mar 31, 2026 to Dec 31, 2026 Site details revised at 1 of 38 sitesv11 Show 1 more changeShow less
    • Site details revised at 1 of 38 sites
  2. Re-verified, no change to tracked fieldsv10
  3. Primary completion date: Feb 2018 to Oct 1, 2019 Start date: Jul 2014 to Sep 8, 2014 · Study sites: 5 to 38 · Completion date: Aug 2021 to Mar 31, 2026 · 5 morev9 Show 8 more changesShow less
    • Start date: Jul 2014 to Sep 8, 2014
    • Study sites: 5 to 38
    • Completion date: Aug 2021 to Mar 31, 2026
    • Interventions: Acalabrutinib (Drug) to Acalabrutinib (ACP-196) (Drug)
    • Eligibility criteria expanded, about 469 words
    • Study description expanded, about 96 words
    • Study title revised
    • Study arms: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  4. Results first posted: Apr 24, 2020 Primary endpoint revised · Completion date: Aug 2019 to Aug 2021 · Secondary endpoints expanded, about 20 words · 1 morev8 Show 4 more changesShow less
    • Primary endpoint revised
    • Completion date: Aug 2019 to Aug 2021
    • Secondary endpoints expanded, about 20 words
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date changed from estimate of Sep 2017 to Feb 2018 Completion date: Jan 2020 to Aug 2019v7 Show 1 more changeShow less
    • Completion date: Jan 2020 to Aug 2019
  6. Phase: Phase 1/2 to Phase 2 Primary completion date: Dec 2016 to Sep 2017 · Primary endpoint revised · Enrollment target: estimated 88 to confirmed 106 · 4 morev6 Show 7 more changesShow less
    • Primary completion date: Dec 2016 to Sep 2017
    • Primary endpoint revised
    • Enrollment target: estimated 88 to confirmed 106
    • Completion date: Jan 2018 to Jan 2020
    • Interventions: ACP-196 (Drug) to Acalabrutinib (Drug)
    • Eligibility criteria revised
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  7. Trial status: Recruiting to Active, Not Recruiting Study sites revised (5)v5 Show 1 more changeShow less
    • Study sites revised (5)

    See this version in full on ClinicalTrials.gov ↗

  8. Phase: Phase 1 to Phase 1/2 Enrollment target: 32 to 88 · Primary completion date: Sep 2015 to Dec 2016 · Primary endpoint revised · 5 morev4 Show 8 more changesShow less
    • Enrollment target: 32 to 88
    • Primary completion date: Sep 2015 to Dec 2016
    • Primary endpoint revised
    • Study sites: 8 to 5
    • Completion date: Jan 2018
    • Eligibility criteria shortened, about 16 words
    • Study title revised
    • Study arms: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites revised (8)v3 See this version in full on ClinicalTrials.gov ↗
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 7 to 8v2 Show 1 more changeShow less
    • Study sites: 7 to 8
  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 evaluate the safety, pharmacokinetics, pharmacodynamics, and activity of acalabrutinib in treating subjects with WM.
Trial Details
NCT Number NCT02180724
Lead Sponsor Acerta Pharma BV
Conditions Waldenström Macroglobulinemia (WM)
Enrollment 107 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov