Marginal Zone Lymphoma
Conditions
Keywords
Marginal Zone Lymphoma, Zanubrutinib, Rituximab
Brief summary
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
DRUGZanubrutinib
160mg twice daily continuous oral administration.
DRUGRituximab
375mg/m2, Intravenous administration on day 1 of each 3-week cycle
Sponsors
Henan Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete response rate | 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 | the total proportion of patients with complete response (CR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | 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 | the total proportion of patients with complete response (CR) and partial response (PR) |
| progression-free survival | 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) | the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first |
| overall survival | 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) | from date of first day of treatment to the date of death by any cause |
| incidence and relationship with study drugs of grade 3-4 adverse events | 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) | the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v5.0) |
Countries
China
Contacts
Primary ContactZhihua Yao, M.D. Ph.D
Outcome results
None listed