Phase 2-3 Trial Comparing Rituximab with Ibrutinib Versus Dexamethasone, Rituximab, and Cyclophosphamide as First Treatment for Waldenstroms Macroglobulinemia

What this Trial Is About

Waldenstrf6ms macroglobulinaemia WM is a rare, slow-growing lymphoma that develops due to abnormal growth of white blood cells. This condition mainly affects older adults, with a median age of over 70 years. Current treatments often do not provide lasting responses and can have significant side effects. Researchers are evaluating a chemotherapy-free treatment option combining ibrutinib with rituximab RI to potentially improve treatment outcomes, reduce toxicity, and enhance quality of life compared to the existing chemotherapy regimen. The study compares two treatment groups for adults aged 18 and over with untreated WM. One group receives the experimental chemotherapy-free combination of ibrutinib and rituximab RI, while the control group is treated with the standard chemotherapy regimen of dexamethasone, rituximab, and cyclophosphamide DRC. Treatment cycles last up to six cycles, with response assessments after three cycles and at the end of treatment around 24 weeks. Participants in the RI group may continue with up to five years of ibrutinib alone after randomised treatment. Participants will have regular visits during treatment and then every three months for five years after stopping treatment. Annual follow-up for survival continues until the study ends, which is expected to last over nine years. Researchers will monitor treatment responses, progression-free survival, side effects, overall survival, quality of life using questionnaires, and other outcomes to assess the benefits and risks of the two therapies.

Rituximab and Ibrutinib (RI) Versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as Initial Therapy for Waldenström's Macroglobulinaemia