Efficacy of First Line B-RI for Treatment Naive Waldenström's Macroglobulinemia
Status:
Recruiting
Trial end date:
2029-09-01
Target enrollment:
Participant gender:
Summary
In Waldenström macroglobulinemia (WM) conventional chemotherapy induces only low complete
remission (CR) rates and responses of short duration compared to other indolent lymphomas.
Thus innovative approaches are needed which combine excellent activity and tolerability in
patients with WM, who are mostly of advanced age. The immunochemotherapy DRC (dexamethasone,
rituximab, cyclophosphamide) was shown to be highly effective in patients with WM without
inducing major hematological toxicities. On the other hand the proteasome inhibitor
bortezomib showed substantial activity as a single agent in WM with only very few side
effects when given in a weekly schedule. Recent data confirmed high activity with low
toxicity for ibrutinib in relapsed WM patients as single agent therapy. Based on these
observations it is the aim of this study to investigate the efficacy and toxicity of the
chemotherapy-free combination bortezomib, rituximab, ibrutinib (B-RI) in treatment naïve WM
patient.
Phase:
Phase 2
Details
Lead Sponsor:
Christian Buske
Collaborators:
ClinAssess Hoffmann-La Roche Johnson & Johnson University of Ulm Zentrum für Klinische Studien Ulm