Waldenström's Macroglobulinemia (WM)BRZ-WMNCT06942507
Zanubrutinib Combined With BR in the First-line Treatment of Waldenström's Macroglobulinemia
A study testing Zanubrutinib and Bendamustine + Rituximab in people with Waldenström's Macroglobulinemia (WM), run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Waldenström's Macroglobulinemia (WM)
- What is being tested?
- Zanubrutinib and Bendamustine + Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated symptomatic Waldenström macroglobulinemia (WM) meeting IWWM-7 diagnostic criteria:
- 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.
- MYD88 L265P mutation is detected in peripheral blood or bone marrow.
- Serum monoclonal IgM ≥5 g/L.
Who cannot join
- 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
- Seropositive for human immunodeficiency virus
- Hepatitis B virus (HBV)-DNA > 1000 copies/mL
- Seropositive for hepatitis C (except in the setting of a sustained virologic response)
- Neutrophil <1×10E9/L, platelet < 75×10E9/L, alanine transaminase (ALT) or aspertate aminotransferase (AST) > 2.5 × upper limit of normal (ULN), total bilirubin > 1.5 × ULN，eGFR < 30 mL/min, or receiving renal replacement therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing
Jiayue Li, 86+01069156874, lijiayue@pumch.cn
About this study
Official title: A Multicenter Study on the First-line Treatment of Waldenström's Macroglobulinemia With Zanubrutinib in Combination With Rituximab and Bendamustine
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.
- Conditions
- Waldenström's Macroglobulinemia (WM)
- Being tested
- Zanubrutinib, Bendamustine + Rituximab
- Keywords
- Rituximab, Zanubrutinib, MYD88, Waldenström's Macroglobulinemia, Bendamustine
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
zanubrutinib 160mg po bid d1-28
Bendamustine + RituximabDrug
bendamustine 70-90mg/m2 ivgtt d1-2, rituximab 375mg/m2 ivgtt d1
| Study group | Role | What they receive |
|---|---|---|
| BRZ | Experimental | participants recieve 4 to 6 cycles of the zanubrutinib-rituximab-bendamustine regimen Receives: Drug: Zanubrutinib; Drug: Bendamustine + Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Complete Response (CR) at 4 to 6 Months After Treatment Initiation
Measured: 4 to 6 months after treatment initiation
Secondary outcomes (6)
Number of Participants Achieving Very Good Partial Response (VGPR) at 4 to 6 Months After Treatment Initiation
Measured: 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)
Measured: 4 to 6 months after treatment initiation
Rate of Progression-Free Survival
Measured: 2 years
Time to next treatment
Measured: 2 years
Rate of Overall Survival
Measured: 2 years
Duration of response
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenström's Macroglobulinemia (WM)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942507
- Sponsor's protocol ID
- BRZ-WM
- Acronym
- BRZ-WM
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study on the First-line Treatment of Waldenström's Macroglobulinemia With Zanubrutinib in Combination With Rituximab and Bendamustine
- ClinicalTrials.gov ID
- NCT06942507
- Acronym / sponsor ID
- BRZ-WM / BRZ-WM
- Conditions
- Waldenström's Macroglobulinemia (WM)
- Keywords
- Rituximab, Zanubrutinib, MYD88, Waldenström's Macroglobulinemia, Bendamustine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRZ | Experimental | Drug: Zanubrutinib, Drug: Bendamustine + Rituximabparticipants recieve 4 to 6 cycles of the zanubrutinib-rituximab-bendamustine regimen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Previously untreated symptomatic Waldenström macroglobulinemia (WM) meeting IWWM-7 diagnostic criteria:
- MYD88 L265P mutation is detected in peripheral blood or bone marrow.
- Serum monoclonal IgM ≥5 g/L.
Key exclusion criteria (8 listed)
- 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
- Seropositive for human immunodeficiency virus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zanubrutinibzanubrutinib 160mg po bid d1-28 | Drug | BRZ |
| Bendamustine + Rituximabbendamustine 70-90mg/m2 ivgtt d1-2, rituximab 375mg/m2 ivgtt d1 | Drug | BRZ |
Primary outcome
Number of Participants Achieving Complete Response (CR) at 4 to 6 Months After Treatment Initiation
Time frame: 4 to 6 months after treatment initiation
6 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zanubrutinib and Bendamustine + Rituximab in people with Waldenström's Macroglobulinemia (WM), run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Li (86+18610852525, lijian@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.