MZLNCT07492407
CD20 Monoclonal Antibody-Based First-Line Therapy in Treatment-Naive Marginal Zone B-Cell Lymphoma
An observational study of MZL, run by Henan Cancer Hospital.
Trial summary
This is a multicenter, real-world study on first-line CD20 monoclonal antibody-based regimens for treatment-naive marginal zone B-cell lymphoma based on risk stratification. The primary objective is to evaluate the efficacy and safety of the "BR", "R2", and "OR2" treatment regimens in treatment-naive MZL patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MZL
- What is being tested?
- R2/BR/OR2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Feb 2028
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital
Who may be able to join
- Histologically confirmed marginal zone B-cell lymphoma (MZL) in accordance with the 2016 WHO classification;
- Age ≥ 18 years, with no gender restriction;
- Patients with MZL requiring systemic therapy, including but not limited to:
- Gastric extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma), HP-positive or HP-negative, with progression/relapse after local therapy (including surgery, radiotherapy, and anti-Helicobacter pylori treatment);
- Non-gastric MALT lymphoma:
- Patients with Ann Arbor Stage I-II disease with progression/relapse after local therapy (including surgery, radiotherapy, etc.); Patients with newly diagnosed Ann Arbor Stage III-IV disease meeting the GELF criteria as recommended by the NCCN Guidelines;
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- Splenic marginal zone lymphoma (SMZL):
- Patients with progression/relapse after local therapy (including splenectomy, antiviral therapy in HCV-positive patients, etc.); Or newly diagnosed with: progressive or painful splenomegaly, symptomatic or progressive cytopenia, defined as Hb < 100 g/L, PLT < 80 × 10⁹/L, or absolute neutrophil count (ANC) < 1.0 × 10⁹/L;
- Nodal marginal zone lymphoma (NMZL):
- Patients with Ann Arbor Stage I-II disease with progression/relapse after local therapy (including surgery, radiotherapy, etc.); Patients with newly diagnosed Ann Arbor Stage III-IV disease meeting the GELF criteria as recommended by the NCCN Guidelines;
- ECOG performance status 0, 1, or 2 (Appendix 4);
- Adequate general condition, with a life expectancy > 3 months;
- Adequate bone marrow function (except for cytopenia caused by the underlying disease), liver function, and renal function;
- Commitment to comply with study procedures and cooperate throughout the entire study period;
- The patient or his/her legally authorized representative must provide written informed consent prior to any study-specific tests or procedures;
- For women of childbearing potential: agreement to use adequate contraceptive measures during study treatment and for at least 1 year after treatment completion.Men must agree to practice abstinence or use barrier contraception.
Who cannot join
- Histological transformation to high-grade lymphoma.
- Known central nervous system (CNS) involvement by lymphoma or evidence of CNS disease.
- Prior systemic therapy, including immunotherapy, chemotherapy, or targeted therapy.
- Prior autologous stem cell transplantation, or allogeneic tissue / solid organ transplantation.
- History of other invasive malignancies that were not treated with curative intent or for which anticancer treatment (including hormone therapy for breast or prostate cancer) was administered within the past 3 years.
- Presence of uncontrolled cardiovascular or cerebrovascular diseases (e.g., New York Heart Association class III or IV heart failure, arrhythmia, myocardial infarction, stroke, or intracranial hemorrhage), coagulation disorders, connective tissue diseases, severe infectious diseases (including active tuberculosis), or other similar conditions.
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- Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (positive result by polymerase chain reaction [PCR]).Seropositivity is permitted; patients with HBV DNA < 10³ IU/mL may be enrolled. HCV RNA must be negative.
- Administration of a live attenuated vaccine within 4 weeks prior to initiation of study treatment.Receipt of live attenuated vaccines, including influenza vaccines, is prohibited during the study period.
- Requirement for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Risk-Stratified Real-World Multicenter Study of the Efficacy and Safety of CD20 Monoclonal Antibody-Based First-Line Therapy in Treatment-Naive Marginal Zone B-Cell Lymphoma
This is a multicenter, real-world study on first-line CD20 monoclonal antibody-based regimens for treatment-naive marginal zone B-cell lymphoma based on risk stratification. The primary objective is to evaluate the efficacy and safety of the "BR", "R2", and "OR2" treatment regimens in treatment-naive MZL patients receiving first-line CD20 monoclonal antibody-based therapy stratified by risk.
- Conditions
- MZL
- Being tested
- R2/BR/OR2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R2/BR/OR2Drug
R2 regimen: 28-day cycle Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Lenalidomide was given orally at 20 mg per day from Day 1 to Day 21 of each cycle (Cycles 1-6).
BR regimen: 28-day cycle
Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Bendamustine was given via intravenous infusion at 70 mg/m² on Day 1 and Day 2 of each cycle (Cycles 1-6).
OR2 regimen: 21-day cycle
Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Lenalidomide was given orally at 20 mg per day from Day 2 to Day 11 of each cycle (Cycles 1-6); Orelabrutinib was administered orally at 150 mg per day for 2 years .
| Study group | Role | What they receive |
|---|---|---|
| R2/BR/OR2 | For patients with low-risk marginal zone B-cell lymphoma (MZL-IPI score: 0-2 points), the "R2" regimen is preferred as the first-line treatment. If the patients are unable to tolerate or are not suitable for the R2 regimen, the "BR" regimen may be administered as an alternative..
For patients with high-risk marginal zone B-cell lymphoma (MZL-IPI score: 3-5 points), the "R2" or "OR2" regimen is administered for first-line treatment. Receives: Drug: R2/BR/OR2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate（CRR）
The proportion of patients who achieved complete remission (CR) after the completion of treatment was evaluated in accordance with the revised criteria for the assessment of malignant lymphoma efficacy proposed at the 2014 Lugano Conference
Measured: up to 24 weeks
Secondary outcomes (2)
2-year progression-free survival (PFS) rate
The percentage of patients who remained alive and free of disease progression at 2 years after study entry, whichever occurred first
Measured: 2 years
2-year overall survival (OS) rate
The percentage of patients who remained alive at 2 years after study entry.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MZLStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 131 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, KeshuZhou, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492407
- Sponsor's protocol ID
- 2025-726-002
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-Stratified Real-World Multicenter Study of the Efficacy and Safety of CD20 Monoclonal Antibody-Based First-Line Therapy in Treatment-Naive Marginal Zone B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07492407
- Acronym / sponsor ID
- 2025-726-002
- Conditions
- MZL
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- Apr 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 25 Mar 2026 (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 multicenter, real-world study on first-line CD20 monoclonal antibody-based regimens for treatment-naive marginal zone B-cell lymphoma based on risk stratification. The primary objective is to evaluate the efficacy and safety of the "BR", "R2", and "OR2" treatment regimens in treatment-naive MZL patients receiving first-line CD20 monoclonal antibody-based therapy stratified by risk.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R2/BR/OR2 | – | Drug: R2/BR/OR2For patients with low-risk marginal zone B-cell lymphoma (MZL-IPI score: 0-2 points), the "R2" regimen is preferred as the first-line treatment. If the patients are unable to tolerate or are not suitable for the R2 regimen, the "BR" regimen may be administered as an alternative.. For patients with high-risk marginal zone B-cell lymphoma (MZL-IPI score: 3-5 points), the "R2" or "OR2" regimen is administered for first-line treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital
Key inclusion criteria (16 listed)
- Histologically confirmed marginal zone B-cell lymphoma (MZL) in accordance with the 2016 WHO classification;
- Age ≥ 18 years, with no gender restriction;
- Patients with MZL requiring systemic therapy, including but not limited to:
- Patients with Ann Arbor Stage I-II disease with progression/relapse after local therapy (including surgery, radiotherapy, etc.); Patients with newly diagnosed Ann Arbor Stage III-IV disease meeting the GELF criteria as recommended by the NCCN Guidelines;
- Patients with progression/relapse after local therapy (including splenectomy, antiviral therapy in HCV-positive patients, etc.); Or newly diagnosed with: progressive or painful splenomegaly, symptomatic or progressive cytopenia, defined as Hb < 100 g/L, PLT < 80 × 10⁹/L, or absolute neutrophil count (ANC) < 1.0 × 10⁹/L;
Key exclusion criteria (9 listed)
- Histological transformation to high-grade lymphoma.
- Known central nervous system (CNS) involvement by lymphoma or evidence of CNS disease.
- Prior systemic therapy, including immunotherapy, chemotherapy, or targeted therapy.
- Prior autologous stem cell transplantation, or allogeneic tissue / solid organ transplantation.
- History of other invasive malignancies that were not treated with curative intent or for which anticancer treatment (including hormone therapy for breast or prostate cancer) was administered within the past 3 years.
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 |
|---|---|---|
| R2/BR/OR2R2 regimen: 28-day cycle Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Lenalidomide was given orally at 20 mg per day from Day 1 to Day 21 of each cycle (Cycles 1-6). BR regimen: 28-day cycle Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Bendamustine was given via intravenous infusion at 70 mg/m² on Day 1 and Day 2 of each cycle (Cycles 1-6). OR2 regimen: 21-day cycle Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Lenalidomide was given orally at 20 mg per day from Day 2 to Day 11 of each cycle (Cycles 1-6); Orelabrutinib was administered orally at 150 mg per day for 2 years . | Drug | R2/BR/OR2 |
Primary outcome
Complete Response Rate（CRR）
Time frame: up to 24 weeks
The proportion of patients who achieved complete remission (CR) after the completion of treatment was evaluated in accordance with the revised criteria for the assessment of malignant lymphoma efficacy proposed at the 2014 Lugano Conference
2 secondary outcomes
2-year progression-free survival (PFS) rate
Time frame: 2 years
2-year overall survival (OS) rate
Time frame: 2 years
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 25 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of MZL, run by Henan Cancer Hospital.
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 16 inclusion and 9 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: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Keshu Zhou (136 7490 2391, dr_zkshu23810@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate（CRR） (time frame: up to 24 weeks). 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 25 Mar 2026.