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

ConditionWaldenström's Macroglobulinemia (WM)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Zanubrutinib

    Drug

    zanubrutinib 160mg po bid d1-28

  • Bendamustine + Rituximab

    Drug

    bendamustine 70-90mg/m2 ivgtt d1-2, rituximab 375mg/m2 ivgtt d1

Treatment groups

104 Participants
are divided into 1 treatment group
Group A: BRZExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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 outcomes

1

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
2

Number of Participants Achieving Overall Response (OR) at 4 to 6 Months After Treatment Initiation

CR + VGPR + partial response (PR)

Time frame
4 to 6 months after treatment initiation
3

Rate of Progression-Free Survival

Time frame
2 years
4

Time to next treatment

Time frame
2 years

Other outcomes

1

Medical resource utilization

Time frame
4 to 6 months after treatment initiation

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: