Zanubrutinib Combined With BR in the First-line Treatment of Waldenström's Macroglobulinemia

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment for patients with Waldenström macroglobulinemia (WM), a type of blood cancer. The treatment combines three medications: zanubrutinib, bortezomib, and rituximab. Researchers believe that this combination may help patients achieve deeper remission, which means a better chance of living longer without the disease. Currently, the standard treatments either don’t achieve the best results or can cause significant side effects when used alone. This trial specifically targets patients whose cancer has a certain genetic mutation called MYD88 L265P.

To be eligible for this trial, patients must have been diagnosed with symptomatic WM and meet specific diagnostic criteria. They should also have a certain level of a protein called IgM in their blood. However, patients with certain health issues, like uncontrolled infections or other cancers, will not be able to participate. If someone joins the trial, they can expect to receive the combination therapy and be closely monitored for both effectiveness and side effects. This study is currently not recruiting participants, so it's important to check back for updates if you or someone you know is interested.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Previously untreated symptomatic Waldenström macroglobulinemia (WM) meeting IWWM-7 diagnostic criteria:
• • 1. Presence of monoclonal IgM-type immunoglobulin in serum
• • 2. Bone marrow infiltration by plasmacytoid lymphocytes or bone marrow biopsy showing small lymphocytes/plasma cells/plasmacytoid lymphocytes (any quantity) in the intertrabecular space
• • 3. Exclusion of other non-Hodgkin lymphoma subtypes
• • 4. 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.
• • 2. MYD88 L265P mutation is detected in peripheral blood or bone marrow.
• • 3. Serum monoclonal IgM ≥5 g/L.
• Exclusion Criteria:
• • 1. Co-morbidity of uncontrolled infection or autoimmune disease
• • 2. Co-morbidity of other active malignancy
• • 3. Co-morbidity of uncontrolled heart disease
• • 4. Co-morbidity of severe digestive system disorders precluding oral medication
• • 5. Seropositive for human immunodeficiency virus
• • 6. Hepatitis B virus (HBV)-DNA \> 1000 copies/mL
• • 7. Seropositive for hepatitis C (except in the setting of a sustained virologic response)
• • 8. Neutrophil \<1×10E9/L, platelet \< 75×10E9/L, alanine transaminase (ALT) or aspertate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN), total bilirubin \> 1.5 × ULN，eGFR \< 30 mL/min, or receiving renal replacement therapy.