Ibrutinib, Bortezomib and Rituximab-CHOP for the Treatment of Elderly Patients With CD20+ DLBCL, IPI ≥ 2
Status:
Recruiting
Trial end date:
2025-01-31
Target enrollment:
Participant gender:
Summary
The ImbruVeRCHOP-Trials is an Investigator-initiated, single-arm, multi-center, prospective,
open phase I/II trial to evaluate the efficacy and feasibility of Ibrutinib and Bortezomib in
the therapy of higher-risk DLBCL patients of different molecular subtypes and to correlate
outcome with clinical, molecular and imaging-guided response parameters. The protocol
includes a safety run-in phase, i.e. the phase I part of the study, to uncover unexpected
toxicities that may arise in the context of Ibrutinib and Bortezomib co-administered with the
R-CHOP backbone. The safety run-in phase is followed by the phase II part of the trial. About
60 patients will be included over 3 years. Additional 8-11 German university centers will
participate in this trial. The study treatment includes a pre-phase therapy with Prednisone
and 6 cycles of a combined immuno-chemotherapy with the anti-CD20 antibody Rituximab together
with 6 cycles of a chemotherapy consisting of Cyclophosphamide, Doxorubicin, Vincristine and
Prednisone plus Bortezomib and Ibrutinib followed by two additional 3-week cycles of
Rituximab. Secondary endpoints are the predictive power of subtypes (such as
GCB/ABC-"cell-of-origin"), markers of minimal residual disease over time and
during-the-study-determined markers (e.g. gene signatures) to identify patients who benefit
from this treatment addition.