Zanubrutinib plus rituximab as first-line treatment for marginal zone lymphoma
Official title: A Multicenter Prospective Real-world Study of Zanubrutinib Combined With Rituximab (ZR) in the First-line Treatment for Patients With Marginal Zone Lymphoma (MZL)
Run by Henan Cancer Hospital · NCT07233720 · Data updated 2026-11-12
This tests whether combining zanubrutinib and rituximab is effective and safe as first-line treatment for people with CD20-positive marginal zone lymphoma who have not received prior systemic therapy.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | rituximab, zanubrutinib |
| Locations | 1 site (Zhengzhou, Henan) |
| Status | Recruiting |
| Started | November 18, 2025 |
| Main results expected | June 2028 |
| Study ends | June 2030 |
| Registry record updated | November 18, 2025 |
| Trial ID | NCT07233720 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with CD20-positive marginal zone lymphoma who have not received prior systemic therapy, have at least one measurable lesion, and can comply with treatment and follow-up are the intended participants.
✕Probably not a fit
Patients with prior systemic anti‑tumor therapy, active other malignancies requiring treatment, or those needing additional anti‑tumor drugs beyond zanubrutinib and rituximab are unlikely to benefit from enrollment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-arm, multi-center real-world observational study using the combination of zanubrutinib and rituximab (ZR) in the first-line setting for marginal zone lymphoma (MZL). Eligible patients are treatment‑naïve, CD20‑positive, and have at least one measurable lesion by imaging. Patients receive zanubrutinib plus rituximab and are followed for clinical response and adverse events under routine clinical conditions without randomization. The study aims to capture efficacy and safety outcomes in a practice-based population to complement data from controlled trials.
Why it matters
Potential benefit: If successful, the combination could offer an effective and well-tolerated first-line option for patients with marginal zone lymphoma.
How similar studies have gone: BTK inhibitors including zanubrutinib have shown activity in marginal zone lymphoma and combinations with rituximab have produced promising results in related B‑cell lymphomas, though randomized first‑line data in MZL remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with CD20-positive marginal zone lymphoma diagnosed by histopathology 2. First-line treatment with the combination regimen of zanubrutinib and rituximab 3. No receiving systematic treatment before enrollment 4. Having at least one measurable lesions. Measurable lesions were defined as: the longest diameter of lymph node lesions in CT cross-sectional images \> 1.5 cm, or the longest diameter of the extranodal lesion is greater than 1.0cm 5. The patients voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up. Exclusion Criteria: 1. Other malignant tumor history or active malignant tumor need be treated 2. In addition to zanubrutinib and rituximab, other anti-tumor drug treatments were also received simultaneously (except for glucocorticoids aimed at controlling symptoms before formal treatment).
Where it's running
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Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China Recruiting
Study contacts
- Study coordinator: Zhihua Yao, M.D. Ph.D
- Email: zlyyyaozhihua1260@zzu.edu.cn
- Phone: +8613592622292
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.