drugset / Trial / NCT03731234
Ibrutinib + R-CHOP Followed by Ibrutinib Maintenance
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibrutinib | Small molecule | 560 mg | — |