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

Sponsor
Peking Union Medical College Hospital
Study ID
NCT06942507
Status
Not Yet Recruiting

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Conditions

  • Waldenström's Macroglobulinemia (WM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Apr 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2029

Study Design

Enrollment
104 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BRZ
    participants recieve 4 to 6 cycles of the zanubrutinib-rituximab-bendamustine regimen

Primary Outcome Measure

Number of Participants Achieving Complete Response (CR) at 4 to 6 Months After Treatment Initiation [ Time Frame: 4 to 6 months after treatment initiation ]

Central Contacts