Recruiting NCT07233720
Zanubrutinib Combined With Rituximab in the Treatment for Patients With Marginal Zone Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zanubrutinib, Rituximab.
- Who it may be relevant to
- Registry conditions: Marginal Zone Lymphoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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).
Interventions
- Drug Zanubrutinib
160mg twice daily continuous oral administration. - Drug Rituximab
375mg/m2, Intravenous administration on day 1 of each 3-week cycle
Primary outcome measures
- complete response rate [Time frame: 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]
Secondary outcome measures (4)
- objective response rate [Time frame: 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]
- progression-free survival [Time frame: from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first after last patient's enrollment (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment)]
- overall survival [Time frame: from date of the first cycle of treatment to the date of death from any cause (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment)]
- incidence and relationship with study drugs of grade 3-4 adverse events [Time frame: from the date of the first cycle of treatment to 24 months after last patient's enrollment (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment)]
Eligibility criteria
Inclusion criteria
- Patients with CD20-positive marginal zone lymphoma diagnosed by histopathology
- First-line treatment with the combination regimen of zanubrutinib and rituximab
- No receiving systematic treatment before enrollment
- 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
- The patients voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
- Other malignant tumor history or active malignant tumor need be treated
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university — Zhengzhou
Identifiers
NCT: NCT07233720 · HNSZLYYNHL10