Clinical trial · Observational
Zanubrutinib Combined With Rituximab in the Treatment for Patients With 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)
NCT07233720CI-TRIAL-00097411recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective single arm, multi-center, real-world study to observe the efficacy and safety of ZR (Zanubrutinib combined with Rituximab) in the first-line treatment for patients with marginal zone lymphoma (MZL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Zanubrutinib Combined With Rituximab
- description
- Induction treatment: Rituximab, 375mg/m2, Intravenous administration on day 1 (21 days/cycle); Zanubrutinib, 160mg twice daily continuous oral administration from 1 to 8 cycles (21 days/cycle) Maintenance treatment: Zanubrutinib, 160mg twice daily continuous oral administration for two years (28 days/cycle)
- interventionNames
- Drug: Zanubrutinib
- Drug: Rituximab
Primary outcomes (1)
- measure
- complete response rate
- timeFrame
- every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment (each cycle is 28 days) to 18 months after last patient's enrollment
- description
- the total proportion of patients with complete response (CR)
Secondary outcomes (4)
- measure
- objective response rate
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.