Status:
NOT_YET_RECRUITING
Zanubrutinib Combined With BR in the First-line Treatment of Waldenström's Macroglobulinemia
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Waldenström's Macroglobulinemia (WM)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Current retrospective studies have demonstrated that achieving deep remission following treatment for Waldenström's macroglobulinemia (WM) correlates with prolonged survival. While the bendamustine-ri...
Eligibility Criteria
Inclusion
- Previously untreated symptomatic Waldenström macroglobulinemia (WM) meeting IWWM-7 diagnostic criteria:
- 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 of other non-Hodgkin lymphoma subtypes
- 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.
Exclusion
- Co-morbidity of uncontrolled infection or autoimmune disease
- Co-morbidity of other active malignancy
- Co-morbidity of uncontrolled heart disease
- Co-morbidity of severe digestive system disorders precluding oral medication
- Seropositive for human immunodeficiency virus
- Hepatitis B virus (HBV)-DNA \> 1000 copies/mL
- Seropositive for hepatitis C (except in the setting of a sustained virologic response)
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06942507
Start Date
May 1 2025
End Date
April 30 2029
Last Update
April 30 2025
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China