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A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL

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

Record History

  1. 2 versions Re-verified since May 8, 2026, no change to tracked fieldsv28-v29
  2. Site details revised at 2 of 157 sitesv27
  3. 4 versions Re-verified since Nov 26, 2024, no change to tracked fieldsv23-v26
  4. Completion date: Sep 6, 2027 to Oct 1, 2027v22
  5. Completion date: Sep 3, 2027 to Sep 6, 2027v21
Show 19 earlier versionsHide 19 earlier versions
  1. Re-verified, no change to tracked fieldsv20
  2. Site details revised at 1 of 157 sitesv19
  3. Re-verified, no change to tracked fieldsv18
  4. Results first posted: Jun 29, 2023 Enrollment target: 311 to 310v17 Show 1 more changeShow less
    • Enrollment target: 311 to 310
  5. Re-verified, no change to tracked fieldsv16
  6. Secondary endpoints: details revised at 7 of 7 entriesv15
  7. Secondary endpoints: details revised at 7 of 7 entriesv14
  8. Primary endpoint revised Completion date: Sep 3, 2026 to Sep 3, 2027 · Secondary endpoints: 6 to 7v13 Show 2 more changesShow less
    • Completion date: Sep 3, 2026 to Sep 3, 2027
    • Secondary endpoints: 6 to 7

    See this version in full on ClinicalTrials.gov ↗

  9. Re-verified, no change to tracked fieldsv12
  10. Site details revised at 3 of 157 sitesv11
  11. Study sites: 159 to 157v10
  12. Primary completion date: Jun 25, 2021 to Sep 3, 2021 Completion date: Mar 19, 2026 to Sep 3, 2026v9 Show 1 more changeShow less
    • Completion date: Mar 19, 2026 to Sep 3, 2026
  13. Primary completion date: Jan 15, 2019 to Jun 25, 2021 Primary endpoint revised · Enrollment target: 310 to 311 · Study sites: 153 to 159 · 4 morev8 Show 7 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 310 to 311
    • Study sites: 153 to 159
    • Completion date: Mar 2021 to Mar 19, 2026
    • Start date: Feb 28, 2017 to Feb 2, 2017
    • Eligibility criteria expanded, about 1,168 words
    • Secondary endpoints: 4 to 6

    See this version in full on ClinicalTrials.gov ↗

  14. Primary endpoint revised Enrollment target: estimated 306 to confirmed 310 · Study sites: 108 to 153 · Completion date: Mar 2020 to Mar 2021 · 1 morev7 Show 4 more changesShow less
    • Enrollment target: estimated 306 to confirmed 310
    • Study sites: 108 to 153
    • Completion date: Mar 2020 to Mar 2021
    • Secondary endpoints: 6 to 4

    See this version in full on ClinicalTrials.gov ↗

  15. Start date: Sep 2016 to Feb 28, 2017 Primary completion date changed from estimate of Jan 2020 to Jan 15, 2019v6 Show 1 more changeShow less
    • Primary completion date changed from estimate of Jan 2020 to Jan 15, 2019
  16. Trial status: Recruiting to Active, Not Recruiting Study sites: 11 to 108v5 Show 1 more changeShow less
    • Study sites: 11 to 108
  17. Primary endpoint revised Study sites: 8 to 11 · Interventions: ACP-196 (Drug), Bendamustine (Drug), Idelalisib (Drug), Rituximab (Drug) to Acalabrutinib (ACP-196) (Drug), Bendamustine (Drug), Idelalisib (Drug), Rituximab (Drug) · Eligibility criteria expanded, about 88 words · 1 morev4 Show 4 more changesShow less
    • Study sites: 8 to 11
    • Interventions: ACP-196 (Drug), Bendamustine (Drug), Idelalisib (Drug), Rituximab (Drug) to Acalabrutinib (ACP-196) (Drug), Bendamustine (Drug), Idelalisib (Drug), Rituximab (Drug)
    • Eligibility criteria expanded, about 88 words
    • Secondary endpoints: 5 to 6

    See this version in full on ClinicalTrials.gov ↗

  18. Study title expanded, about 2 wordsv3 See this version in full on ClinicalTrials.gov ↗
  19. Study title shortened, about 3 wordsv2 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.
This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).
Trial Details
NCT Number NCT02970318
Lead Sponsor Acerta Pharma BV
Conditions Chronic Lymphocytic Leukemia
Enrollment 310 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov