ClinicalTrials.gov record NCT06942507
Zanubrutinib Combined With BR in the First-line Treatment of Waldenström's Macroglobulinemia
A Multicenter Study on the First-line Treatment of Waldenström's Macroglobulinemia With Zanubrutinib in Combination With Rituximab and Bendamustine
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is an interventional, single‑group study testing zanubrutinib combined with bendamustine and rituximab as first‑line treatment for people with MYD88‑mutated Waldenström's Macroglobulinemia. Participants receive 4 to 6 cycles of the combination regimen. The main outcome is complete response measured 4–6 months after starting treatment; other outcomes include response levels and survival measures up to 2 years.
What it is studying. The study is testing the safety and effectiveness of adding zanubrutinib to the bendamustine‑rituximab (BR) regimen as a first‑line treatment for people with MYD88‑mutated Waldenström's Macroglobulinemia, by measuring response rates and later survival outcomes.
What the researchers hope to learn. To evaluate the regimen's efficacy by measuring complete response (CR), very good partial response (VGPR), and overall response (CR+VGPR+PR) at 4–6 months, and to measure progression‑free survival, time to next treatment, overall survival, and duration of response over 2 years; and to assess safety of the combination.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Zanubrutinib
- Bendamustine + Rituximab
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive 4–6 cycles of combination treatment: oral zanubrutinib (160 mg twice daily, days 1–28 of each cycle) together with intravenous bendamustine (70–90 mg/m2 on days 1–2) and rituximab (375 mg/m2 on day 1) per cycle. Study staff will assess response around 4–6 months after starting treatment and will continue monitoring outcomes (progression-free survival, time to next treatment, overall survival, and duration of response) for up to 2 years. Expect regular clinic visits for IV infusions, taking daily oral medication during cycles, and routine tests to monitor disease response and safety.
How the study is structured. Interventional, single‑group, open‑label trial. All participants receive zanubrutinib (160 mg orally twice daily) together with bendamustine (70–90 mg/m2 IV on days 1–2) and rituximab (375 mg/m2 IV on day 1) for 4–6 cycles. Responses are assessed at about 4–6 months; longer outcomes (progression‑free survival, time to next treatment, overall survival, duration of response) are followed up to 2 years.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Waldenström macroglobulinemia
Important dates
- Study start
- May 1, 2025 (estimated)
- Primary completion
- Apr 30, 2027 (estimated)
- Study completion
- Apr 30, 2029 (estimated)
- Target enrollment
- 104 participants (estimated)
- Last updated on registry
- Apr 30, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Peking Union Medical College Hospital
- Principal investigator
- Jian Li, Professor
Peking Union Medical College Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Jian Li 📞 86+18610852525 ✉ lijian@pumch.cn
- Jia Chen 📞 86+18813002022 ✉ chenjiapumc@yeah.net
Participating sites (1)
- Peking Union Medical College Hospital
Beijing · China
- Jiayue Li · 86+01069156874 · lijiayue@pumch.cn
Terms used on this page · explanations by MedicalUpdates.ai
- Previously untreated
- Has not previously received the treatment, or the type of treatment, that the study is about.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- upper limit of normal
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- eGFR
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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