Marginal Zone Lymphoma (MZL)Phase 2NCT07372365
Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve MZL.
A Phase 2 study testing Orelabrutinib Consolidation and Maintenance Therapy in people with Marginal Zone Lymphoma (MZL), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study aims to explore a new treatment approach for patients with treatment-naive Marginal Zone Lymphoma (MZL). MZL is a type of slow-growing lymphoma that often affects older adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marginal Zone Lymphoma (MZL)
- What is being tested?
- Orelabrutinib Consolidation and Maintenance Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2025to 1 Oct 2030
- Phase
- Phase 2
- 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
Who may be able to join
- Histologically confirmed CD20-positive marginal zone lymphoma (MZL) that has not received systemic therapy.
- MZL that has progressed or relapsed after prior local therapy (local therapy includes surgery, radiotherapy, Helicobacter pylori eradication, and hepatitis C treatment) or is not amenable to local therapy.
- Age ≥18 years.
- Presence of an indication for treatment as determined by the investigator or patient's willingness to receive treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
- Adequate organ function as defined below:
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- Hematology: Hemoglobin (HB) ≥60 g/L, platelets (PLT) ≥50×10⁹/L, neutrophils (NE) ≥1.0×10⁹/L (Note: Subjects with cytopenia due to lymphoma bone marrow involvement are not restricted by this criterion).
- Cardiac: Left ventricular ejection fraction (LVEF) ≥50% as determined by echocardiogram.
- Renal: Creatinine ≤1.5×upper limit of normal (ULN) or creatinine clearance ≥30 ml/min.
- Hepatic: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN.
- Women of childbearing potential must have a negative pregnancy test. Both male and female patients must agree to use effective contraception during the treatment period and for 2 years thereafter.
- Life expectancy of more than 3 months.
- Voluntary provision of written informed consent.
Who cannot join
- Underwent major surgery or severe trauma within 2 weeks prior to enrollment, or has not yet recovered from significant adverse effects.
- Has other malignancies currently or within the past 3 years, excluding those that have been cured (such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, prostatic intraepithelial neoplasia, and cervical carcinoma in situ).
- Has a history of stroke or intracranial hemorrhage within the past 3 months.
- Requires anticoagulation with warfarin or equivalent vitamin K antagonist.
- Has evidence of any comorbidities or medical conditions that may interfere with the conduct of the study or place the patient at significant risk, including but not limited to severe cardiovascular disease (e.g., New York Heart Association class III or IV heart disease, myocardial infarction within the past 6 months, unstable arrhythmia, or unstable angina) and/or severe pulmonary disease (e.g., severe obstructive pulmonary disease and a history of symptomatic bronchospasm).
- Is infected with human immunodeficiency virus, or has uncontrollable active hepatitis C virus or hepatitis B virus infection.
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- Has uncontrollable active infection.
- Is pregnant or breastfeeding.
- Has any life-threatening disease, medical condition, or organ dysfunction that may jeopardize the safety of the patient, as determined by the investigator.
- Has any condition that may interfere with the absorption or metabolism of orelabrutinib or place the study results at unnecessary risk.
- Has central nervous system involvement by marginal zone lymphoma or evidence of disease transformation.
- Has any condition that the investigator judges may interfere with the patient's full participation in the study; any condition that poses significant risk to the patient; or any condition that may interfere with the interpretation of study data.
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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Ting Xu, DOCTOR, 051265228033, 21132075@qq.com
Ting Xu, DOCTOR
About this study
Official title: Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve Marginal Zone Lymphoma: A Study of Efficacy and Safety.
This study aims to explore a new treatment approach for patients with treatment-naive Marginal Zone Lymphoma (MZL). MZL is a type of slow-growing lymphoma that often affects older adults. The current standard treatment involves chemotherapy, but it can have significant side effects and may not always provide long-term benefits. This study investigates a treatment strategy that combines a limited course of chemotherapy (R-CHOP) followed by consolidation and maintenance therapy with a targeted drug called Orelabrutinib.
Patients will undergo a series of tests to determine eligibility for the study. These tests include blood work, imaging studies, and assessments of overall health. Eligible participants will receive a standard chemotherapy regimen called R-CHOP for three cycles. After this, the response to treatment will be evaluated. Participants who show a good response will then receive three cycles of consolidation therapy with Orelabrutinib and Rituximab (OR). Those who continue to respond well will enter a maintenance phase with Orelabrutinib for up to two years. Throughout the study, participants will be closely monitored for treatment response and any side effects. Regular check-ups, blood tests, and imaging studies will be conducted to assess the effectiveness and safety of the treatment.
This study is an important step towards finding better treatment options for MZL patients. It is hoped that through this research, the quality of life and outcomes for those affected by this disease can be improved.
- Conditions
- Marginal Zone Lymphoma (MZL)
- Being tested
- Orelabrutinib Consolidation and Maintenance Therapy
- 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.
Orelabrutinib Consolidation and Maintenance TherapyDrug
Eligible subjects will receive R-CHOP regimen (with a 21-day cycle). After 3 cycles of treatment, the efficacy will be assessed. Subjects with disease progression or those who do not achieve partial remission (PR) after treatment will discontinue treatment. The remaining subjects will continue to receive 3 cycles of OR regimen for consolidation therapy. After 6 cycles, efficacy will be assessed again. Subjects assessed as complete remission (CR) or PR will enter the orelabrutinib maintenance treatment phase for a total of 2 years, until completion of the protocol treatment, disease progression, or unacceptable toxicity (whichever occurs first).
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib Consolidation and Maintenance Therapy in Marginal Zone Lymphoma | Experimental | Eligible subjects will receive R-CHOP regimen (with a 21-day cycle). After 3 cycles of treatment, the efficacy will be assessed. Subjects with disease progression or those who do not achieve partial remission (PR) after treatment will discontinue treatment. The remaining subjects will continue to receive 3 cycles of OR regimen for consolidation therapy. After 6 cycles, efficacy will be assessed again. Subjects assessed as complete remission (CR) or PR will enter the orelabrutinib maintenance treatment phase for a total of 2 years, until completion of the protocol treatment, disease progression, or unacceptable toxicity (whichever occurs first). Receives: Drug: Orelabrutinib Consolidation and Maintenance Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR) rate after 6 treatment cycles
Measured: Efficacy will be assessed at the end of the combined induction and consolidation therapy (6 cycles in total). Each treatment cycle is 21 days.
Secondary outcomes (4)
Progression-free Survival (PFS)
Measured: From the first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.
Overall survival（OS）
Measured: From the first dose of study treatment until the date of death from any cause, assessed up to 60 months.
Overall Response Rate (ORR) after 6 treatment cycles
Measured: Efficacy will be assessed at the end of the combined induction and consolidation therapy (6 cycles in total). Each treatment cycle is 21 days.
Adverse events
Measured: From the first dose of study treatment until 30 days after the last dose, or until the start of new anti-cancer therapy, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start24 Oct 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Oct 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 Lymphoma (MZL)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372365
- Sponsor's protocol ID
- 2025808
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve Marginal Zone Lymphoma: A Study of Efficacy and Safety.
- ClinicalTrials.gov ID
- NCT07372365
- Acronym / sponsor ID
- 2025808
- Conditions
- Marginal Zone Lymphoma (MZL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 28 Jan 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 study aims to explore a new treatment approach for patients with treatment-naive Marginal Zone Lymphoma (MZL). MZL is a type of slow-growing lymphoma that often affects older adults. The current standard treatment involves chemotherapy, but it can have significant side effects and may not always provide long-term benefits. This study investigates a treatment strategy that combines a limited course of chemotherapy (R-CHOP) followed by consolidation and maintenance therapy with a targeted drug called Orelabrutinib.
Patients will undergo a series of tests to determine eligibility for the study. These tests include blood work, imaging studies, and assessments of overall health. Eligible participants will receive a standard chemotherapy regimen called R-CHOP for three cycles. After this, the response to treatment will be evaluated. Participants who show a good response will then receive three cycles of consolidation therapy with Orelabrutinib and Rituximab (OR). Those who continue to respond well will enter a maintenance phase with Orelabrutinib for up to two years. Throughout the study, participants will be closely monitored for treatment response and any side effects. Regular check-ups, blood tests, and imaging studies will be conducted to assess the effectiveness and safety of the treatment.
This study is an important step towards finding better treatment options for MZL patients. It is hoped that through this research, the quality of life and outcomes for those affected by this disease can be improved.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib Consolidation and Maintenance Therapy in Marginal Zone Lymphoma | Experimental | Drug: Orelabrutinib Consolidation and Maintenance TherapyEligible subjects will receive R-CHOP regimen (with a 21-day cycle). After 3 cycles of treatment, the efficacy will be assessed. Subjects with disease progression or those who do not achieve partial remission (PR) after treatment will discontinue treatment. The remaining subjects will continue to receive 3 cycles of OR regimen for consolidation therapy. After 6 cycles, efficacy will be assessed again. Subjects assessed as complete remission (CR) or PR will enter the orelabrutinib maintenance treatment phase for a total of 2 years, until completion of the protocol treatment, disease progression, or unacceptable toxicity (whichever occurs first). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed CD20-positive marginal zone lymphoma (MZL) that has not received systemic therapy.
- MZL that has progressed or relapsed after prior local therapy (local therapy includes surgery, radiotherapy, Helicobacter pylori eradication, and hepatitis C treatment) or is not amenable to local therapy.
- Age ≥18 years.
- Presence of an indication for treatment as determined by the investigator or patient's willingness to receive treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
Key exclusion criteria (12 listed)
- Underwent major surgery or severe trauma within 2 weeks prior to enrollment, or has not yet recovered from significant adverse effects.
- Has other malignancies currently or within the past 3 years, excluding those that have been cured (such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, prostatic intraepithelial neoplasia, and cervical carcinoma in situ).
- Has a history of stroke or intracranial hemorrhage within the past 3 months.
- Requires anticoagulation with warfarin or equivalent vitamin K antagonist.
- Has evidence of any comorbidities or medical conditions that may interfere with the conduct of the study or place the patient at significant risk, including but not limited to severe cardiovascular disease (e.g., New York Heart Association class III or IV heart disease, myocardial infarction within the past 6 months, unstable arrhythmia, or unstable angina) and/or severe pulmonary disease (e.g., severe obstructive pulmonary disease and a history of symptomatic bronchospasm).
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 |
|---|---|---|
| Orelabrutinib Consolidation and Maintenance TherapyEligible subjects will receive R-CHOP regimen (with a 21-day cycle). After 3 cycles of treatment, the efficacy will be assessed. Subjects with disease progression or those who do not achieve partial remission (PR) after treatment will discontinue treatment. The remaining subjects will continue to receive 3 cycles of OR regimen for consolidation therapy. After 6 cycles, efficacy will be assessed again. Subjects assessed as complete remission (CR) or PR will enter the orelabrutinib maintenance treatment phase for a total of 2 years, until completion of the protocol treatment, disease progression, or unacceptable toxicity (whichever occurs first). | Drug | Orelabrutinib Consolidation and Maintenance Therapy in Marginal Zone Lymphoma |
Primary outcome
Complete response (CR) rate after 6 treatment cycles
Time frame: Efficacy will be assessed at the end of the combined induction and consolidation therapy (6 cycles in total). Each treatment cycle is 21 days.
4 secondary outcomes
Progression-free Survival (PFS)
Time frame: From the first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.
Overall survival（OS）
Time frame: From the first dose of study treatment until the date of death from any cause, assessed up to 60 months.
Overall Response Rate (ORR) after 6 treatment cycles
Time frame: Efficacy will be assessed at the end of the combined induction and consolidation therapy (6 cycles in total). Each treatment cycle is 21 days.
Adverse events
Time frame: From the first dose of study treatment until 30 days after the last dose, or until the start of new anti-cancer therapy, whichever occurs first.
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 28 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orelabrutinib Consolidation and Maintenance Therapy in people with Marginal Zone Lymphoma (MZL), run by The First Affiliated Hospital of Soochow University 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 13 inclusion and 12 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 28 Jan 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (CR) rate after 6 treatment cycles (time frame: Efficacy will be assessed at the end of the combined induction and consolidation therapy (6 cycles in total). Each treatment cycle is 21 days.). 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 28 Jan 2026.