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A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)

Study acronym: ESCALADE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv44
  2. Study sites: 255 to 243 Primary and study completion dates: Feb 1, 2027 to Feb 22, 2027v43 Show 1 more changeShow less
    • Primary and study completion dates: Feb 1, 2027 to Feb 22, 2027
  3. Re-verified, no change to tracked fieldsv42
  4. Site details revised at 7 of 255 sitesv41
  5. Primary and study completion dates: Feb 5, 2027 to Feb 1, 2027v40
Show 38 earlier versionsHide 38 earlier versions
  1. 3 versions Re-verified since Sep 26, 2024, no change to tracked fieldsv37-v39
  2. Study sites: 254 to 255v36
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 600 to confirmed 611 · Study sites: 315 to 254v35 Show 2 more changesShow less
    • Enrollment target: estimated 600 to confirmed 611
    • Study sites: 315 to 254
  4. Study sites: 307 to 315v34
  5. Study sites: 304 to 307v33
  6. Study sites: 305 to 304v32
  7. Study sites: 303 to 305v31
  8. Study sites: 293 to 303v30
  9. Study sites: 291 to 293v29
  10. Study sites: 280 to 291 Primary and study completion dates: Aug 31, 2026 to Feb 5, 2027 · Eligibility criteria revised · Study description revisedv28 Show 3 more changesShow less
    • Primary and study completion dates: Aug 31, 2026 to Feb 5, 2027
    • Eligibility criteria revised
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  11. Re-verified, no change to tracked fieldsv27
  12. Study sites: 276 to 280 Primary and study completion dates: Feb 21, 2027 to Aug 31, 2026v26 Show 1 more changeShow less
    • Primary and study completion dates: Feb 21, 2027 to Aug 31, 2026
  13. Study sites: 275 to 276 Primary and study completion dates: Aug 31, 2026 to Feb 21, 2027v25 Show 1 more changeShow less
    • Primary and study completion dates: Aug 31, 2026 to Feb 21, 2027
  14. Study sites: 273 to 275v24
  15. Site details revised at 1 of 273 sitesv23
  16. Study sites: 271 to 273v22
  17. Study sites: 269 to 271 Eligibility criteria shortened, about 46 words · Secondary endpoints revised (3)v21 Show 2 more changesShow less
    • Eligibility criteria shortened, about 46 words
    • Secondary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

  18. Site details revised at 7 of 269 sitesv20
  19. Site details revised at 4 of 269 sitesv19
  20. Study sites: 270 to 269v18
  21. Study sites: 268 to 270v17
  22. Study sites: 260 to 268v16
  23. Re-verified, no change to tracked fieldsv15
  24. Study sites: 259 to 260v14
  25. Study sites: 258 to 259 Secondary endpoints: details revised at 3 of 3 entries · Study description revised · Eligibility criteria expanded, about 2 words · 1 morev13 Show 4 more changesShow less
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description revised
    • Eligibility criteria expanded, about 2 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  26. Site details revised at 10 of 258 sitesv12
  27. Study sites: 257 to 258v11
  28. Re-verified, no change to tracked fieldsv10
  29. Study sites: 256 to 257v9
  30. Study sites: 251 to 256v8
  31. Site details revised at 84 of 251 sitesv7
  32. Study sites: 209 to 251v6
  33. Study sites: 203 to 209v5
  34. Study sites: 179 to 203v4
  35. Study sites: 102 to 179v3
  36. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 102 · Start date changed from estimate of Sep 30, 2020 to Oct 8, 2020v2 Show 2 more changesShow less
    • Study sites: 0 to 102
    • Start date changed from estimate of Sep 30, 2020 to Oct 8, 2020
  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.
Acerta Pharma BV
17 trials monitored
See 1 trial at risk
Non-Hodgkin Lymphoma
1,517 trials monitored
See 84 trials at risk
DLBCL
650 trials monitored
See 38 trials at risk
Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.
Trial Details
NCT Number NCT04529772
Lead Sponsor Acerta Pharma BV
Collaborators: AstraZeneca
Conditions Diffuse Large B-Cell Lymphoma
Enrollment 611 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov