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A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

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

Record History

  1. Eligibility criteria expanded, about 9 words Site details revised at 2 of 228 sites · Publications: details revised at 1 of 1 entry Show 2 more changesShow less
    • Site details revised at 2 of 228 sites
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv46
  3. Primary and study completion dates: Oct 28, 2025 to Feb 15, 2027v45
  4. 4 versions Re-verified since Jun 17, 2024, no change to tracked fieldsv41-v44
  5. Site details revised at 4 of 228 sitesv40
Show 38 earlier versionsHide 38 earlier versions
  1. Re-verified, no change to tracked fieldsv39
  2. Study sites: 221 to 228v38
  3. Primary completion date: Apr 30, 2023 to Oct 28, 2025 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 546 to confirmed 635 · Study sites: 232 to 221 · 1 morev37 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 546 to confirmed 635
    • Study sites: 232 to 221
    • Completion date: Feb 28, 2024 to Oct 28, 2025
  4. Enrollment target: 626 to 546 Completion date: Apr 30, 2023 to Feb 28, 2024v36 Show 1 more changeShow less
    • Completion date: Apr 30, 2023 to Feb 28, 2024
  5. Re-verified, no change to tracked fieldsv35
  6. Study sites: 231 to 232v34
  7. 4 versions Re-verified since Sep 23, 2022, no change to tracked fieldsv30-v33
  8. Study sites: 230 to 231v29
  9. Study sites: 250 to 230v28
  10. Site details revised at 4 of 250 sitesv27
  11. Study sites: 251 to 250v26
  12. Enrollment target: 546 to 626 Study sites: 136 to 251 · Primary and study completion dates: Nov 14, 2022 to Apr 30, 2023 · Collaborators expanded, about 1 wordv25 Show 3 more changesShow less
    • Study sites: 136 to 251
    • Primary and study completion dates: Nov 14, 2022 to Apr 30, 2023
    • Collaborators expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites: 110 to 136v24
  14. Study sites: 76 to 110v23
  15. Study sites: 71 to 76v22
  16. Re-verified, no change to tracked fieldsv21
  17. Study sites: 69 to 71v20
  18. Study sites: 68 to 69v19
  19. Study sites: 63 to 68v18
  20. Study sites: 46 to 63v17
  21. Interventions: Acalabrutinib (Drug), Bendamustine (Drug), Rituximab (Drug) to Acalabrutinib (Drug), Bendamustine (Drug), Placebo (Drug), Rituximab (Drug)v16
  22. Start date: Feb 1, 2017 to Apr 5, 2017 Study sites: 241 to 46 · Primary completion date: Oct 2022 to Nov 14, 2022 · Completion date: Apr 2023 to Nov 14, 2022 · 4 morev15 Show 7 more changesShow less
    • Study sites: 241 to 46
    • Primary completion date: Oct 2022 to Nov 14, 2022
    • Completion date: Apr 2023 to Nov 14, 2022
    • Interventions: Acalabrutinib in combination with bendamustine and rituximab (Drug), Placebo in combination with bendamustine and rituximab (Drug) to Acalabrutinib (Drug), Bendamustine (Drug), Rituximab (Drug)
    • Secondary endpoints: details revised at 6 of 6 entries
    • Study description expanded, about 46 words
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  23. Site details revised at 195 of 241 sitesv14
  24. Study sites: 239 to 241v13
  25. Re-verified, no change to tracked fieldsv12
  26. Study sites: 235 to 239v11
  27. Study sites: 212 to 235v10
  28. Study sites: 197 to 212v9
  29. Study sites: 36 to 197 Eligibility criteria shortened, about 1 wordv8 Show 1 more changeShow less
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  30. Re-verified, no change to tracked fieldsv7
  31. Study sites revised (36)v6 See this version in full on ClinicalTrials.gov ↗
  32. Study sites: 21 to 36 Eligibility criteria expanded, about 17 wordsv5 Show 1 more changeShow less
    • Eligibility criteria expanded, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  33. Study sites: 8 to 21 Start date: Feb 2017 to Feb 1, 2017v4 Show 1 more changeShow less
    • Start date: Feb 2017 to Feb 1, 2017
  34. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 8v3 Show 1 more changeShow less
    • Study sites: 0 to 8
  35. Study title shortened, about 1 wordv2 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 evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.
Trial Details
NCT Number NCT02972840
Lead Sponsor Acerta Pharma BV
Collaborators: AstraZeneca
Conditions Lymphoma, Mantle Cell
Enrollment 635 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov