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ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Jan 21, 2026, no change to tracked fieldsv34-v35
  2. Completion date: Sep 6, 2027 to Jun 9, 2027v33
  3. 7 versions Re-verified since Nov 6, 2023, no change to tracked fieldsv26-v32
  4. Completion date: Jul 15, 2026 to Sep 6, 2027v25
  5. 2 versions Re-verified since Nov 23, 2022, no change to tracked fieldsv23-v24
Show 21 earlier versionsHide 21 earlier versions
  1. Results first posted: Sep 10, 2022 Primary endpoints: 1 to 14 · Interventions: acalabrutinib (Drug) to Acalabrutinib (Drug) · Eligibility criteria expanded, about 16 words · 3 morev22 Show 6 more changesShow less
    • Primary endpoints: 1 to 14
    • Interventions: acalabrutinib (Drug) to Acalabrutinib (Drug)
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints expanded, about 30 words
    • Study arms: 1 to 5
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv21
  3. Site details revised at 5 of 12 sitesv20
  4. 2 versions Re-verified since Jul 19, 2021, no change to tracked fieldsv18-v19
  5. Completion date: Dec 31, 2025 to Jul 15, 2026 Site details revised at 5 of 12 sitesv17 Show 1 more changeShow less
    • Site details revised at 5 of 12 sites
  6. Primary completion date: Jan 2021 to Jul 15, 2021 Completion date: Dec 31, 2025 · Start date: Jan 2014 to Jan 30, 2014 · Eligibility criteria expanded, about 588 words · 1 morev16 Show 4 more changesShow less
    • Completion date: Dec 31, 2025
    • Start date: Jan 2014 to Jan 30, 2014
    • Eligibility criteria expanded, about 588 words
    • Study sites revised (12)

    See this version in full on ClinicalTrials.gov ↗

  7. Primary completion date: Jan 2019 to Jan 2021 Enrollment target: estimated 286 to confirmed 306 · Study sites: 13 to 12v15 Show 2 more changesShow less
    • Enrollment target: estimated 286 to confirmed 306
    • Study sites: 13 to 12
  8. Study sites: 7 to 13 Interventions: ACP-196 (Drug) to acalabrutinib (Drug) · Eligibility criteria revised · Study title expanded, about 1 wordv14 Show 3 more changesShow less
    • Interventions: ACP-196 (Drug) to acalabrutinib (Drug)
    • Eligibility criteria revised
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  9. Trial status: Recruiting to Active, Not Recruiting Study sites revised (7)v13 Show 1 more changeShow less
    • Study sites revised (7)

    See this version in full on ClinicalTrials.gov ↗

  10. Enrollment target: 440 to 286v12
  11. Primary completion date: Jan 2017 to Jan 2019 Eligibility criteria shortened, about 16 wordsv11 Show 1 more changeShow less
    • Eligibility criteria shortened, about 16 words

    See this version in full on ClinicalTrials.gov ↗

  12. Phase: Phase 1 to Phase 1/2 Study sites: 6 to 7 · Eligibility criteria revisedv10 Show 2 more changesShow less
    • Study sites: 6 to 7
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  13. Re-verified, no change to tracked fieldsv9
  14. Enrollment target: 36 to 440 Primary completion date: Jan 2016 to Jan 2017 · Study sites: 5 to 6 · Eligibility criteria expanded, about 20 wordsv8 Show 3 more changesShow less
    • Primary completion date: Jan 2016 to Jan 2017
    • Study sites: 5 to 6
    • Eligibility criteria expanded, about 20 words

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 4 to 5v7
  16. Study sites revised (4)v6 See this version in full on ClinicalTrials.gov ↗
  17. 2 versions Re-verified since May 30, 2014, no change to tracked fieldsv4-v5
  18. Study sites: 3 to 4v3
  19. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3v2 Show 1 more changeShow less
    • Study sites: 0 to 3
  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 evaluating the safety and efficacy of a new BTK inhibitor, acalabrutinib, for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Trial Details
NCT Number NCT02029443
Lead Sponsor Acerta Pharma BV
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome, Prolymphocytic Leukemia
Enrollment 306 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov