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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
104
zanubrutinib 160mg po bid d1-28
bendamustine 70-90mg/m2 ivgtt d1-2, rituximab 375mg/m2 ivgtt d1
Peking Union Medical College Hospital
Beijing, China
Number of Participants Achieving Complete Response (CR) at 4 to 6 Months After Treatment Initiation
Time frame: 4 to 6 months after treatment initiation
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
CR + VGPR + partial response (PR)
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
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