A Phase II Clinical Study of Zanubrutinib Combined With Four Cycles of CD20 Monoclonal Antibody and Reduced-Dose Bendamustine in the Treatment of Untreated Waldenström Macroglobulinemia

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07259122
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Waldenström Macroglobulinemia (WM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Zaunbrutinib, Bendamustine and Rituximab for induction therapy — DRUG
    Patients in the experimental group will receive treatment in 4-week cycles, totaling 4 cycles of zanubrutinib + bendamustine + CD20 Monoclonal Antibody therapy, followed by 8 months of zanubrutinib monotherapy maintenance. Specific regimen: Zanubrutinib: Oral administration starts on Day 1 of Cycle 1 and continues continuously at 160 mg twice daily. Bendamustine: Intravenous infusion at 70 mg/m² on Days 1-2 of Cycles 1-4. CD20 Monoclonal Antibody: Intravenous infusion at 375 mg/m² on Day 0 of Cycles 1-4. After completing the 4-cycle combination therapy, a systematic efficacy evaluation will be conducted.
  • Zanubrutinib mono therapy for maintenance treatment — DRUG
    Patients will then continue with zanubrutinib monotherapy maintenance for 8 months before treatment discontinuation.

Study Details

This study is a prospective phase II clinical trial designed to evaluate the deep response rate of the ZBR regimen (zanubrutinib combined with reduced-dose bendamustine and CD20 Monoclonal Antibody ) in treatment-naïve symptomatic Waldenström macroglobulinemia (WM) patients. Eligible patients will receive four cycles of the ZBR regimen, followed by zanubrutinib monotherapy for an additional eight months. The assessment period spans from the initiation of treatment until 12 months after treatment completion, with efficacy evaluations conducted every three cycles. Patients will be withdrawn from the study if they experience disease progression (PD) or show no response to treatment. Minimal residual disease (MRD) assessments will be performed at the end of the 3rd and 6th treatment cycles, as well as 12 months after treatment completion, involving evaluations of both bone marrow and peripheral blood MRD rates

Key Dates

Start date
Dec 30, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2032

Study Design

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

Arms

  • Experimental: Experimental: ZBR

Primary Outcome Measure

Best deep response rate(≥VGPR) [ Time Frame: up to 1 year ]

Central Contacts