Zanubrutinib Plus BR in Newly Diagnosed Symptomatic WM

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT05914662
Phase
PHASE2
Status
Recruiting
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Conditions

  • Waldenstrom Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib, Bendamustine and Rituximab — DRUG
    Zanubrutinib, 160mg orally, twice a day; Bendamustine 70 mg/m2 on days 1 and 2 of each cycle; Rituximab (375 mg/m2 intravenously on day 0 of each cycle. ZBR was administered every 4 weeks for a total of 6 cycles, followed by maintenance therapy with zanubrutinib monotherapy for another 6 months.

Study Details

This study aims to evaluate the long-term efficacy of BTK inhibitor Zanubrutinib combined bendamustine and rituximab (ZBR) for time-limited treatment of Waldenstrom macroglobulinemia, The combination therapy is expected to improve the remission depth, prolong the remission time, and improve the progression-free survival and overall survival of newly diagnosed WM patients. On the one hand, the patients have to bear a long-term economic burden, which is often difficult for some patients to adhere to for a long time. On the other hand, in the course of long-term treatment of BTKi, drug resistance and intolerable side effects are prone to occur. At the same time, it can prevent the disease rebound after the withdrawal of BTKi, so as to achieve the phased withdrawal of WM

Key Dates

Start date
Feb 15, 2023
Status verified
Aug 2024
Primary completion
Mar 15, 2025
Completion
Dec 15, 2025

Study Design

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

Arms

  • Experimental: Zanubrutinib, bendamustine, rituximab combination therapy Group
    Patients were treated with ZBR regimen for 6 cycles, followed by zanubrutinib monotherapy for an additional 6 months.

Primary Outcome Measure

Best combined complete response (CR) and very good partial response (VGPR) [ Time Frame: up to the end of 12 cycles of treatment(each cycle is 28 days) ]

Central Contacts

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