Clinical Trial

Ibrutinib + R-CHOP Followed by Ibrutinib Maintenance

Active, Not Recruiting Phase 2
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Summary
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
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2018-11-02; most recent amendment 2026-05-29.
Status change: Recruiting → Active, Not Recruiting 2024-12-19
Status change: Not Yet Recruiting → Recruiting 2020-02-05
Trial Details
NCT Number NCT03731234
Lead Sponsor Fondazione Italiana Linfomi - ETS
Collaborators: Janssen-Cilag S.p.A.
Conditions DLBCL
Enrollment 75 participants
Start Date 2019-07-02
Primary Completion 2024-07-30 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-01