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Not yet recruiting NCT06942507

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

No phase Interventional Waldenström's Macroglobulinemia (WM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zanubrutinib, Bendamustine + Rituximab.
Who it may be relevant to
Registry conditions: Waldenström's Macroglobulinemia (WM). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Multicenter Study on the First-line Treatment of Waldenström's Macroglobulinemia With Zanubrutinib in Combination With Rituximab and Bendamustine

Overview

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.

Interventions

  • Drug Zanubrutinib
    zanubrutinib 160mg po bid d1-28
  • Drug Bendamustine + Rituximab
    bendamustine 70-90mg/m2 ivgtt d1-2, rituximab 375mg/m2 ivgtt d1

Primary outcome measures

  • Number of Participants Achieving Complete Response (CR) at 4 to 6 Months After Treatment Initiation [Time frame: 4 to 6 months after treatment initiation]
Secondary outcome measures (6)
  • Number of Participants Achieving Very Good Partial Response (VGPR) at 4 to 6 Months After Treatment Initiation [Time frame: 4 to 6 months after treatment initiation]
  • Number of Participants Achieving Overall Response (OR) at 4 to 6 Months After Treatment Initiation [Time frame: 4 to 6 months after treatment initiation]
  • Rate of Progression-Free Survival [Time frame: 2 years]
  • Time to next treatment [Time frame: 2 years]
  • Rate of Overall Survival [Time frame: 2 years]
  • Duration of response [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT06942507 · BRZ-WM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗