About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial population

Patients with CD20-positive marginal zone lymphoma diagnosed by histopathology for first-line treatment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Zanubrutinib
Drug
160mg twice daily continuous oral administration.
Rituximab
Drug
375mg/m2, Intravenous administration on day 1 of each 3-week cycle

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Zanubrutinib Combined With Rituximab2 interventions

Trial outcomes

Primary outcomes

1

complete response rate

the total proportion of patients with complete response (CR)

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 outcomes

1

objective response rate

the total proportion of patients with complete response (CR) and partial response (PR)

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

2

progression-free survival

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

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)

3

overall survival

from date of first day of treatment to the date of death by any cause

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)

4

incidence and relationship with study drugs of grade 3-4 adverse events

the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v5.0)

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)

Zanubrutinib Combined With Rituximab in the Treatment for Patients With Marginal Zone Lymphoma

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts