Clinical trial · Interventional
Zanubrutinib Combined With BR in the First-line Treatment of Waldenström's Macroglobulinemia
A Multicenter Study on the First-line Treatment of Waldenström's Macroglobulinemia With Zanubrutinib in Combination With Rituximab and Bendamustine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Waldenström's Macroglobulinemia (WM) | Waldenstrom Macroglobulinemia | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine + Rituximab | Drug | — | UNRESOLVED |
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BRZ
- description
- participants recieve 4 to 6 cycles of the zanubrutinib-rituximab-bendamustine regimen
- interventionNames
- Drug: Zanubrutinib
- Drug: Bendamustine + Rituximab
Primary outcomes (1)
- measure
- Number of Participants Achieving Complete Response (CR) at 4 to 6 Months After Treatment Initiation
- timeFrame
- 4 to 6 months after treatment initiation
Secondary outcomes (6)
- measure
- Number of Participants Achieving Very Good Partial Response (VGPR) at 4 to 6 Months After Treatment Initiation
- timeFrame
- 4 to 6 months after treatment initiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available