A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)

StatusRecruiting
PhasePhase 3
Started

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Record History

The 50 most recent of 110 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 203 → 206 locations
  2. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised at 18 of 203 sites
  3. Study sites: 201 to 203v108
  4. Re-verified, no change to tracked fieldsv107
  5. Study sites: 200 to 201v106
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  1. Site details revised at 1 of 200 sitesv105
  2. Study sites: 199 to 200v104
  3. Study sites: 198 to 199v103
  4. Site details revised at 1 of 198 sitesv102
  5. Study sites: 197 to 198v101
  6. Study sites revised (197)v100
  7. Study sites: 196 to 197v99
  8. Study sites revised (196)v98
  9. Site details revised at 6 of 196 sitesv97
  10. Study sites: 195 to 196v96
  11. Site details revised at 1 of 195 sitesv95
  12. Site details revised at 1 of 195 sitesv94
  13. Study sites revised (195)v93
  14. Site contacts updated at 6 of 195 sitesv92
  15. Study sites: 194 to 195v91
  16. Study sites: 193 to 194v90
  17. Site details revised at 1 of 193 sitesv89
  18. Study sites revised (193)v88
  19. Site contacts updated at 1 of 193 sitesv87
  20. Site contacts updated at 2 of 193 sitesv86
  21. Site contacts updated at 1 of 193 sitesv85
  22. Study sites: 192 to 193v84
  23. Study sites: 191 to 192v83
  24. Study sites revised (191)v82
  25. Study sites: 190 to 191v81
  26. Site details revised at 2 of 190 sitesv80
  27. Site details revised at 2 of 190 sitesv79
  28. Site details revised at 1 of 190 sitesv78
  29. Study sites: 189 to 190v77
  30. Study sites: 187 to 189v76
  31. Study sites: 185 to 187v75
  32. Study sites: 184 to 185v74
  33. Site details revised at 7 of 184 sites
    • Eligibility criteria expanded, about 3 words
    v73
  34. Primary and study completion dates: Sep 30, 2032 to Sep 7, 2032v72
  35. Site contacts updated at 8 of 184 sitesv71
  36. Study sites: 183 to 184v70
  37. Study sites: 182 to 183v69
  38. Study sites: 180 to 182v68
  39. Site contacts updated at 1 of 180 sitesv67
  40. Site contacts updated at 2 of 180 sitesv66
  41. Study sites: 177 to 180v65
  42. Study sites: 178 to 177v64
  43. Study sites: 175 to 178v63
  44. Site contacts updated at 2 of 175 sitesv62
  45. Study sites: 174 to 175v61
  • 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 goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.
Trial Details
NCT Number NCT06136559
Lead Sponsor Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Related terms Leukemia, Lymphocytic, Chronic, B-Cell
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov