Zanubrutinib plus rituximab as first-line treatment for marginal zone lymphoma
A Multicenter Prospective Real-world Study of Zanubrutinib Combined With Rituximab (ZR) in the First-line Treatment for Patients With Marginal Zone Lymphoma (MZL)
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | rituximab, zanubrutinib |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT07233720 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Zhengzhou, Henan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.