drugset / Trial / NCT03731234

Ibrutinib + R-CHOP Followed by Ibrutinib Maintenance

NCT03731234 ↗

Phase 2 Active not recruiting 75 enrolled Fondazione Italiana Linfomi - ETS Janssen-Cilag S.p.A. · collab
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2019-07-02
Primary completion
2024-07-30
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 560 mg —