A Long-term Extension Study of PCI-32765 (Ibrutinib)

Study acronym: CAN3001
StatusActive, Not Recruiting
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 167 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC
    • Enrollment closed, study ongoing
    • Final enrollment: 539 participants (planned 700)
    • Site details revised at 175 of 175 sites
  2. Study completion moved earlier from Dec 31, 2030 to Dec 31, 2029
    • Site details revised at 1 of 175 sites
    v166
  3. Study completion pushed from Dec 31, 2029 to Dec 31, 2030
    • Site details revised at 4 of 175 sites
    v165
  4. Study completion pushed from Aug 31, 2027 to Dec 31, 2029
    • Study sites revised (175)
    v164
  5. Study sites: 174 to 175v163
Show 45 earlier versionsHide 45 earlier versions
  1. Re-verified, no change to tracked fieldsv162
  2. Study sites revised (174)v161
  3. Study completion date: Jan 29, 2027 to Aug 31, 2027
    • Study sites revised (174)
    v160
  4. Re-verified, no change to tracked fieldsv159
  5. Study sites revised (174)v158
  6. Site details revised at 5 of 174 sitesv157
  7. Site details revised at 4 of 174 sitesv156
  8. Site details revised at 1 of 174 sitesv155
  9. Re-verified, no change to tracked fieldsv154
  10. Site details revised at 1 of 174 sitesv153
  11. Site details revised at 2 of 174 sitesv152
  12. 2 versions Re-verified since May 22, 2025, no change to tracked fieldsv150-v151
  13. Site details revised at 1 of 174 sitesv149
  14. Re-verified, no change to tracked fieldsv148
  15. Site details revised at 3 of 174 sitesv147
  16. Site details revised at 5 of 174 sitesv146
  17. Re-verified, no change to tracked fieldsv145
  18. Study sites revised (174)v144
  19. Study sites revised (174)v143
  20. Re-verified, no change to tracked fieldsv142
  21. Site details revised at 9 of 174 sitesv141
  22. Trial status: Enrolling by Invitation to Recruiting
    • Site details revised at 174 of 174 sites
    v140
  23. Study sites revised (174)v139
  24. 3 versions Re-verified since Aug 13, 2024, no change to tracked fieldsv136-v138
  25. Study sites revised (174)v135
  26. Study sites revised (174)v134
  27. Re-verified, no change to tracked fieldsv133
  28. Study sites: 173 to 174v132
  29. Study sites revised (173)v131
  30. Re-verified, no change to tracked fieldsv130
  31. Study sites revised (173)v129
  32. Re-verified, no change to tracked fieldsv128
  33. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised at 173 of 173 sites
    v127
  34. Trial status: Enrolling by Invitation to Recruiting
    • Study sites: 172 to 173
    v126
  35. 3 versions Re-verified since Sep 12, 2023, no change to tracked fieldsv123-v125
  36. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised at 172 of 172 sites
    v122
  37. Primary completion date: Jul 14, 2022 to Dec 31, 2026
    • Trial status: Enrolling by Invitation to Recruiting
    • Site details revised at 172 of 172 sites
    v121
  38. Study sites: 170 to 172
    • Primary completion date changed from estimate of Dec 31, 2026 to Jul 14, 2022
    v120
  39. Study sites: 169 to 170v119
  40. Study sites: 166 to 169v118
  • 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.
Johnson & Johnson
289 trials monitored
See 16 trials at risk
Leukemia
2,957 trials monitored
See 176 trials at risk
Non-Hodgkin Lymphoma
2,017 trials monitored
See 114 trials at risk
DLBCL
706 trials monitored
See 46 trials at risk
and 3 more diseases
The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.
Trial Details
NCT Number NCT01804686
Lead Sponsor Janssen Research & Development, LLC
Collaborators: Pharmacyclics LLC.
Conditions
(from sponsor)		 Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, Chronic Graft Versus Host Disease
Related terms Bronchiolitis Obliterans Syndrome, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Waldenstrom Macroglobulinemia
Enrollment 539 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov