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A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL

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

Record History

  1. 12 versions Re-verified since Nov 14, 2023, no change to tracked fieldsv18-v29
  2. Completion date: Jun 20, 2027 to Aug 20, 2027v17
  3. Completion date: Jun 30, 2027 to Jun 20, 2027v16
  4. Completion date: Nov 30, 2022 to Jun 30, 2027v15
  5. Primary completion date: Mar 26, 2026 to Jun 15, 2022 Enrollment target: 61 to 72 · Completion date: Mar 26, 2026 to Nov 30, 2022 · Start date: May 11, 2016 to Apr 20, 2016v14 Show 3 more changesShow less
    • Enrollment target: 61 to 72
    • Completion date: Mar 26, 2026 to Nov 30, 2022
    • Start date: May 11, 2016 to Apr 20, 2016
Show 12 earlier versionsHide 12 earlier versions
  1. Start date: Feb 2016 to May 11, 2016 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 70 to confirmed 61 · Study sites: 14 to 15 · 3 morev13 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 70 to confirmed 61
    • Study sites: 14 to 15
    • Primary and study completion dates: May 2026 to Mar 26, 2026
    • Study description expanded, about 54 words
    • Collaborators expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 15 to 14v12
  3. Study sites revised (15)v11 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Active, Not Recruiting to Recruiting Study sites: 14 to 15v10 Show 1 more changeShow less
    • Study sites: 14 to 15
  5. Primary completion date: Feb 2021 to May 2026 Enrollment target: 48 to 70 · Study sites: 18 to 14 · Completion date: Jun 2021 to May 2026 · 4 morev9 Show 7 more changesShow less
    • Enrollment target: 48 to 70
    • Study sites: 18 to 14
    • Completion date: Jun 2021 to May 2026
    • Interventions: acalabrutinib in combination with BR (Drug) to Acalabrutinib in combination with BR (Drug), Acalabrutinib in combination with VR (Drug)
    • Eligibility criteria shortened, about 36 words
    • Study arms: 2 to 3
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. 2 versions Re-verified since Jan 26, 2018, no change to tracked fieldsv7-v8
  7. Study sites revised (18)v6 See this version in full on ClinicalTrials.gov ↗
  8. Trial status: Recruiting to Active, Not Recruiting Completion date: Jun 2021 · Study sites revised (18)v5 Show 2 more changesShow less
    • Completion date: Jun 2021
    • Study sites revised (18)

    See this version in full on ClinicalTrials.gov ↗

  9. Interventions: ACP-196 in combination with BR (Drug) to acalabrutinib in combination with BR (Drug) Study title revisedv4 Show 1 more changeShow less
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 12 to 18 Eligibility criteria expanded, about 21 words · Study title expanded, about 1 wordv3 Show 2 more changesShow less
    • Eligibility criteria expanded, about 21 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 1 to 12 Eligibility criteria expanded, about 54 wordsv2 Show 1 more changeShow less
    • Eligibility criteria expanded, about 54 words

    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.
A Phase 1b, Multicenter, Open-label Study of Acalabrutinib in Combination with Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR) in Subjects with Mantle Cell Lymphoma
Trial Details
NCT Number NCT02717624
Lead Sponsor Acerta Pharma BV
Collaborators: AstraZeneca
Conditions Mantle Cell Lymphoma (MCL)
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov