Zanubrutinib Combined With BR in the First-line Treatment of Waldenström's Macroglobulinemia
NCT ID: NCT06942507
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
104 participants
INTERVENTIONAL
2025-05-01
2029-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BRZ
participants recieve 4 to 6 cycles of the zanubrutinib-rituximab-bendamustine regimen
Zanubrutinib
zanubrutinib 160mg po bid d1-28
Bendamustine + Rituximab
bendamustine 70-90mg/m2 ivgtt d1-2, rituximab 375mg/m2 ivgtt d1
Interventions
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Zanubrutinib
zanubrutinib 160mg po bid d1-28
Bendamustine + Rituximab
bendamustine 70-90mg/m2 ivgtt d1-2, rituximab 375mg/m2 ivgtt d1
Eligibility Criteria
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Inclusion 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
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.
18 Years
75 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Jian Li
Professor
Locations
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Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BRZ-WM
Identifier Type: -
Identifier Source: org_study_id
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