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Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

Study acronym: AMPLIFY
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jan 31, 2027 → Apr 30, 2027
See other at-risk trials from Acerta Pharma BV

Record History

The 50 most recent of 60 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jan 31, 2027 to Apr 30, 2027 Study sites: 170 to 169 Show 1 more changeShow less
    • Study sites: 170 to 169
  2. Study sites: 171 to 170v59
  3. Primary and study completion dates: Jan 6, 2027 to Jan 31, 2027 Site details revised at 10 of 171 sitesv58 Show 1 more changeShow less
    • Site details revised at 10 of 171 sites
  4. Site details revised at 1 of 171 sitesv57
  5. Re-verified, no change to tracked fieldsv56
Show 45 earlier versionsHide 45 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 780 to confirmed 984 · Study sites: 204 to 171v55 Show 2 more changesShow less
    • Enrollment target: estimated 780 to confirmed 984
    • Study sites: 204 to 171
  2. Study sites: 205 to 204v54
  3. Study sites: 202 to 205v53
  4. Study description revisedv52 See this version in full on ClinicalTrials.gov ↗
  5. Site details revised at 2 of 202 sitesv51
  6. 2 versions Re-verified since Dec 14, 2022, no change to tracked fieldsv49-v50
  7. Site details revised at 1 of 202 sitesv48
  8. Site details revised at 1 of 202 sitesv47
  9. Site details revised at 3 of 202 sitesv46
  10. Re-verified, no change to tracked fieldsv45
  11. Study sites: 277 to 202 Study description revisedv44 Show 1 more changeShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  12. Site details revised at 10 of 277 sitesv43
  13. Site details revised at 6 of 277 sitesv42
  14. Study sites: 234 to 277v41
  15. Study sites: 229 to 234v40
  16. Study sites: 224 to 229v39
  17. Study sites: 221 to 224v38
  18. Primary and study completion dates: Mar 26, 2024 to Jan 6, 2027 Study sites: 220 to 221v37 Show 1 more changeShow less
    • Study sites: 220 to 221
  19. Study sites: 212 to 220v36
  20. Site details revised at 10 of 212 sitesv35
  21. Re-verified, no change to tracked fieldsv34
  22. Site details revised at 151 of 212 sitesv33
  23. Re-verified, no change to tracked fieldsv32
  24. Primary completion date: Aug 30, 2022 to Mar 26, 2024 Study sites: 123 to 212 · Completion date: Apr 30, 2024 to Mar 26, 2024v31 Show 2 more changesShow less
    • Study sites: 123 to 212
    • Completion date: Apr 30, 2024 to Mar 26, 2024
  25. Study sites: 113 to 123v30
  26. Study sites: 99 to 113v29
  27. Study sites: 76 to 99v28
  28. Study sites: 74 to 76v27
  29. Study sites: 71 to 74v26
  30. Study sites: 69 to 71v25
  31. Study sites: 51 to 69v24
  32. Study sites: 49 to 51v23
  33. Study sites: 47 to 49v22
  34. Study sites: 44 to 47v21
  35. Study sites: 43 to 44v20
  36. Study sites: 35 to 43v19
  37. Study sites: 31 to 35v18
  38. Study sites: 29 to 31v17
  39. Study sites: 27 to 29v16
  40. Study sites: 25 to 27v15
  41. Study sites: 23 to 25v14
  42. Study sites: 20 to 23v13
  43. Study sites: 19 to 20v12
  44. Study sites: 18 to 19v11
  • 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 efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL
Trial Details
NCT Number NCT03836261
Lead Sponsor Acerta Pharma BV
Collaborators: AstraZeneca
Conditions Chronic Lymphocytic Leukemia
Enrollment 984 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov