Zanubrutinib Combined With BR in the First-line Treatment of Waldenström's Macroglobulinemia (NCT06942507) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Zanubrutinib Combined With BR in the First-line Treatment of Waldenström's Macroglobulinemia
China104 participantsStarted 2025-05-01
Plain-language summary
Current retrospective studies have demonstrated that achieving deep remission following treatment for Waldenström's macroglobulinemia (WM) correlates with prolonged survival. While the bendamustine-rituximab (BR) regimen or single-agent zanubrutinib are currently recommended as first-line therapies, neither achieves optimal deep remission. Additionally, prolonged zanubrutinib monotherapy may lead to cumulative adverse effects. Therefore, this study aims to evaluate the efficacy and safety of the bendamustine-rituximab-zanubrutinib combination regimen as a first-line treatment option for MYD88-mutated WM patients.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Presence of monoclonal IgM-type immunoglobulin in serum
✓. Bone marrow infiltration by plasmacytoid lymphocytes or bone marrow biopsy showing small lymphocytes/plasma cells/plasmacytoid lymphocytes (any quantity) in the intertrabecular space
Exclusion criteria
✕. Typical immunophenotype: CD5-/CD10-/CD19⁺/CD20⁺/CD23-/CD79b⁺ /sIgM⁺/CD138- clonal B-cells. Variant phenotypes may show CD5/CD10/CD23 /CD38 positivity or coexistence of clonal B-cells and plasma cells.
✕. MYD88 L265P mutation is detected in peripheral blood or bone marrow.
✕. Serum monoclonal IgM ≥5 g/L.
✕. Co-morbidity of uncontrolled infection or autoimmune disease
✕. Co-morbidity of other active malignancy
✕. Co-morbidity of uncontrolled heart disease
What they're measuring
1
Number of Participants Achieving Complete Response (CR) at 4 to 6 Months After Treatment Initiation
Timeframe: 4 to 6 months after treatment initiation