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Ibrutinib + R-CHOP Followed by Ibrutinib Maintenance

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since May 29, 2026, no change to tracked fieldsv17-v18
  2. Site details revised at 31 of 39 sitesv16
  3. Site details revised at 31 of 39 sitesv15
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 90 to 75
    • Primary completion date changed from estimate of Jun 2024 to Jul 30, 2024
    • Site details revised at 39 of 39 sites
    v14
  5. Study sites: 38 to 39
    • Primary completion date: Dec 2023 to Jun 2024
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 35 to 38
    • Primary completion date: Jul 2023 to Dec 2023
    v12
  2. Re-verified, no change to tracked fieldsv11
  3. Study sites: 42 to 35
    • Primary completion date: Feb 2023 to Jul 2023
    • Study completion date: Feb 2025 to Jul 2027
    • Eligibility criteria expanded, about 72 words
    v10
  4. Site details revised at 5 of 42 sitesv9
  5. Site details revised at 19 of 42 sitesv8
  6. Study sites: 43 to 42v7
  7. Site details revised at 19 of 43 sitesv6
  8. Site details revised at 7 of 43 sitesv5
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 44 to 43
    • Start date changed from estimate of Jul 2019 to Jul 2, 2019
    v4
  10. Start date: Feb 2019 to Jul 2019v3
  11. Start date: Dec 2018 to Feb 2019
    • Primary completion date: Dec 2022 to Feb 2023
    • Study completion date: Dec 2024 to Feb 2025
    • Study sites revised (44)
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a prospective, multicenter, single arm, phase II trial in patients with ≥ 18 and \<65 years with poor-prognosis (IPI ≥ 2) and newly diagnosed ABC-DLBCL. Aim of the study is to assess the efficacy and the safety of R-CHOP in combination with ibrutinib for 6 cycles followed by ibrutinib maintenance for 18 months in ABC-DLBCL patients achieving at least a PR after the induction phase
Trial Details
NCT Number NCT03731234
Lead Sponsor Fondazione Italiana Linfomi - ETS
Collaborators: Janssen-Cilag S.p.A.
Conditions
(from sponsor)		 DLBCL
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov