Marginal Zone LymphomaNCT07233720
Zanubrutinib Combined With Rituximab in the Treatment for Patients With Marginal Zone Lymphoma
An observational study of Marginal Zone Lymphoma, run by Henan Cancer Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Marginal Zone Lymphoma
- What is being tested?
- Zanubrutinib and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2025to Jun 2030
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with CD20-positive marginal zone lymphoma diagnosed by histopathology for first-line treatment.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan
Zhihua Yao, M.D. Ph.D, +8613592622292, zlyyyaozhihua1260@zzu.edu.cn
About this study
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)
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
- Marginal Zone Lymphoma
- Being tested
- Zanubrutinib, Rituximab
- Keywords
- Marginal Zone Lymphoma, Zanubrutinib, Rituximab
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Also called Zanubrutinib pills
160mg twice daily continuous oral administration.
RituximabDrug
Also called RiTUXimab Injection
375mg/m2, Intravenous administration on day 1 of each 3-week cycle
| Study group | Role | What they receive |
|---|---|---|
| Zanubrutinib Combined With Rituximab | 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) Receives: Drug: Zanubrutinib; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate
the total proportion of patients with complete response (CR)
Measured: 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 (4)
objective response rate
the total proportion of patients with complete response (CR) and partial response (PR)
Measured: 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
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
Measured: 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
from date of first day of treatment to the date of death by any cause
Measured: 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
the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v5.0)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start18 Nov 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Zone LymphomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhihua Yao, PhD, Henan Cancer Hospital
- Investigators
- Zhihua Yao, M.D. Ph.D, Study director, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233720
- Sponsor's protocol ID
- HNSZLYYNHL10
- Status last verified
- Oct 2025
- First submitted
- 8 Jul 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07233720
- Acronym / sponsor ID
- HNSZLYYNHL10
- Conditions
- Marginal Zone Lymphoma
- Keywords
- Marginal Zone Lymphoma, Zanubrutinib, Rituximab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 18 Nov 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zanubrutinib Combined With Rituximab | – | Drug: Zanubrutinib, Drug: RituximabInduction 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with CD20-positive marginal zone lymphoma diagnosed by histopathology for first-line treatment.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanubrutinibAlso: Zanubrutinib pills160mg twice daily continuous oral administration. | Drug | Zanubrutinib Combined With Rituximab |
| RituximabAlso: RiTUXimab Injection375mg/m2, Intravenous administration on day 1 of each 3-week cycle | Drug | Zanubrutinib Combined With Rituximab |
Primary outcome
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
the total proportion of patients with complete response (CR)
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhihua Yao, M.D. Ph.D study director
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Marginal Zone Lymphoma, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhihua Yao, M.D. Ph.D (+8613592622292, zlyyyaozhihua1260@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.