Marginal Zone Lymphoma(MZL)Phase 2NCT07022223
Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma
A Phase 2 study testing orelabrutinib combined with rituximab regimen in people with Marginal Zone Lymphoma(MZL), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 18 sites in China.
Trial summary
This is a single-arm, prospective clinical study to evaluate the efficacy and safety of orelabrutinib combined with rituximab as first-line systemic treatment for marginal zone lymphoma. 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 combined with rituximab regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 18 sitesChina
- Study dates
- 11 Mar 2025to 11 Sep 2029
- 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
- Age ≥ 18 years, regardless of gender;
- Histologically confirmed CD20-positive marginal zone lymphoma, including MALT, SMZL, and NMZL, with at least one lesion outside the spleen measuring more than 1.5 cm in any axis;
- MZL that has progressed or relapsed after prior local therapy (including surgery, radiotherapy, anti-Helicobacter pylori treatment, and anti-hepatitis C treatment), or is not suitable for local therapy;
- ECOG performance status of 0-2;
- Presence of an indication for treatment as judged by the investigator (symptomatic, cytopenia, risk of end-organ damage, bulky disease, ongoing progression, or patient's desire for treatment);
- Adequate function of major organs, as follows:
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- Hematology: Absolute neutrophil count ≥ 1.5×109/L, platelets ≥ 75×109/L, hemoglobin ≥ 75 g/L; if there is bone marrow involvement, absolute neutrophil count ≥ 1.0×109/L, platelets ≥ 50×109/L, hemoglobin ≥ 50 g/L;
- Biochemistry: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST or ALT ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; serum amylase ≤ ULN;
- Coagulation: International normalized ratio (INR) ≤ 1.5 times ULN.
- Life expectancy of ≥ 3 months;
- Voluntary written informed consent obtained before screening for the trial.
Who cannot join
- Currently or previously having other malignancies, unless there is evidence of no recurrence or metastasis within the past 5 years after curative treatment;
- Lymphoma involvement of the central nervous system or transformation to high-grade lymphoma;
- Non-hematological toxicities from prior anti-cancer treatments not recovered to ≤ Grade 1 (excluding alopecia);
- Presence of uncontrolled or significant cardiovascular disease, including:
- New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months before the first administration of the study drug, or arrhythmias requiring treatment at screening, left ventricular ejection fraction (LVEF) < 50%;
- Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);
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- History of clinically significant QTc interval prolongation, or QTc interval > 470 ms for females, > 450 ms for males during the screening period;
- Symptomatic or medically treated coronary artery disease;
- Uncontrolled hypertension (defined as blood pressure not reaching target levels despite a reasonable and tolerable full dose of three or more antihypertensive drugs (including diuretics) for more than one month, or requiring four or more antihypertensive drugs to effectively control blood pressure).
- Active bleeding within 2 months before screening, or currently taking anticoagulant drugs, or deemed by the investigator to have a clear tendency to bleed;
- Urine protein ≥ 2+, and 24-hour urine protein quantification ≥ 2 g/24 hours;
- History of deep vein thrombosis or pulmonary embolism within the past six months;
- History of organ transplantation or allogeneic bone marrow transplantation;
- Major surgery within 6 weeks before screening or minor surgery within 2 weeks before screening. Major surgery is defined as surgery using general anesthesia, but diagnostic endoscopy is not considered major surgery. Insertion of a vascular access device will be exempt from this exclusion criterion;
- Active infection or uncontrolled HBV (HBsAg positive and/or HBcAb positive with positive HBV DNA titer), HCV Ab positive, HIV/AIDS, or other severe infectious diseases;
- Currently having pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or other conditions that significantly affect pulmonary function;
- Previous treatment with BTK, BCR pathway inhibitors (such as PI3K, Syk), or BCL-2 inhibitors;
- Suitable and preparing for stem cell transplantation;
- Any psychiatric or cognitive impairment that may limit their understanding, execution of the informed consent form, and compliance with the study;
- Subjects with drug abuse or alcoholism;
- Pregnant, breastfeeding women, and fertile subjects unwilling to use contraception;
- Need to continuously take drugs with moderate to severe inhibitory or strong inducing effects on cytochrome P450 CYP3A;
- Any other condition deemed by the investigator as unsuitable for participation in this trial.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
China18 sites, 18 recruiting
- Recruiting
Dongyang People's Hospital
Dongyang
gongqiang Wu, +86 13757950788, 13757950788@163.com
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
yun Liang, +86 13957136178, liangyun@zju.edu.cn
yun Liang
- Recruiting
Affiliated Hangzhou First People's Hospital
Hangzhou
yaping Xie, +86 139 5804 4620, xieyapingzj@163.com
- Recruiting
Zhejiang cancer Hospital
Hangzhou
yamin Tan, +86 13750825918, yamin0001@126.com
- Recruiting
Huzhou Central Hospital
Huzhou
lihong Shou, +86 13362216921, SLH077@126.com
- Recruiting
Affiliated Hospital of Jiaxing University
Jiaxing
minchao Yan, +86 13736850599, yanmc2000@163.com
- Recruiting
The Second Affiliated Hospital of Jiaxing University
Jiaxing
beili Hu, +86 13511347134, 87718916@qq.com
- Recruiting
Lishui central Hospital
Lishui
linjie Li, +86 13567615761, 304234447@qq.com
- Recruiting
the Affiliated Peopele'S Hospital of Ningbo University
Ningbo
ying Lu, +86 13586090834, 814871416@qq.com
- Recruiting
Quzhou People's Hospital
Quzhou
wenping Wu, +86 15657009869, 2545095140@qq.com
- Recruiting
Shaoxing Central Hospital
Shaoxing
jianzhi Zhao, +86 15067570789, zhao_jianzhi@163.com
- Recruiting
shaoxing People's Hospital
Shaoxing
jiaping Fu, +86 13867529690, fujiaping1@sina.com
- Recruiting
Taizhou Central Hospital
Taizhou
linglong Xu, +86 18857628662, xull@tzc.edu.cn
- Recruiting
Taizhou First People's Hospital
Taizhou
lili Chen, +86 15105868468, 15105868468@163.com
- Recruiting
Taizhou Hospital ofzhejiang Province
Taizhou
yanping Shao, +86 13586104699, shaoyp@enzemed.com
- Recruiting
The Second Affiliated Hospital and Yuying childrens Hospital of Wenzhou Medical University
Wenzhou
ying Lin, +86 13705883857, wzly1974@hotmail.com
- Recruiting
Yuyao People's Hospital
Yuyao
yongming Xia, +86 19957408686, xymflI@163.com
- Recruiting
Affiliated Zhuji Hospital ofWenzhou Medical University
Zhuji
mei Zhou, +86 13967550366, 104397707@qq.com
About this study
Official title: A Single-arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma
This is a single-arm, prospective clinical study to evaluate the efficacy and safety of orelabrutinib combined with rituximab as first-line systemic treatment for marginal zone lymphoma.
Read the detailed description
Marginal zone lymphoma (MZL) is a relatively common type of B-cell non-Hodgkin lymphoma (B-NHL), with an incidence rate second only to diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). The Bruton tyrosine kinase (BTK) signaling pathway plays a significant role in B-cell malignancies. Most B-cell malignancies require activation of the B-cell receptor (BCR), and BTK, located downstream of the BCR, plays a crucial role in B-cell proliferation, apoptosis, differentiation, and migration induced by antigens. Currently, there is no unified treatment regimen with high-level evidence for the treatment of newly diagnosed MZL. As mentioned above, although high-intensity immunochemotherapy regimens achieve high response rates and durable remission, they also bring higher treatment-related safety risks (with a rate of grade 3 or higher adverse events of about 80%), including treatment-related deaths. Therefore, exploring effective chemotherapy-free regimens for MZL patients is a scientifically valuable and clinically meaningful attempt. Drugs such as BTK inhibitors and CD20 monoclonal antibodies have shown good therapeutic activity and clinical data as single agents. This is a single-arm, prospective clinical study to evaluate the efficacy and safety of orelabrutinib combined with rituximab as first-line systemic treatment for marginal zone lymphoma. All subjects will receive induction treatment with the orelabrutinib and rituximab regimen. The treatment cycle is 28 days, with a total of 6 cycles. Patients who achieve a partial response (PR) or better will enter a 2-year maintenance period with orelabrutinib.
- Conditions
- Marginal Zone Lymphoma(MZL)
- Being tested
- orelabrutinib combined with rituximab regimen
- 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 combined with rituximab regimenDrug
All participants will receive induction therapy with the orelabrutinib and rituximab regimen. The treatment cycle is 28 days, with a total of 6 cycles. The induction treatment period is as follows:
Cycle 1: Rituximab, 375 mg/m², on Day 1. Cycles 2-6:Orelabrutinib, 150 mg, once daily orally, from Day 1 to Day 28. Rituximab, 375 mg/m², on Day 1.
Patients who achieve a partial response (PR) or better will enter a 2-year maintenance period with orelabrutinib.
| Study group | Role | What they receive |
|---|---|---|
| orelabrutinib combined with rituximab regimen | Experimental | All participants will receive induction therapy with the orelabrutinib and rituximab regimen. The treatment cycle is 28 days, with a total of 6 cycles. The induction treatment period is as follows:
Cycle 1: Rituximab, 375 mg/m², on Day 1. Cycles 2-6:Orelabrutinib, 150 mg, once daily orally, from Day 1 to Day 28. Rituximab, 375 mg/m², on Day 1.
Patients who achieve a partial response (PR) or better will enter a 2-year maintenance period with orelabrutinib. Receives: Drug: orelabrutinib combined with rituximab regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR is defined as the proportion of patients with a response of CR or PR
Measured: up to 6 months
Secondary outcomes (7)
Complete Response Rate (CR)
The rate of patients who achieved complete response after treatment
Measured: up to 6 months
Best Overall Response (BOR)
The best response achieved by the patient from the start of treatment until disease progression or the initiation of a new treatment regimen.
Measured: up to 6 months
Duration of Response (DoR)
Duration of response as defined as the period from the first response (at least PR) to treatment until evidence of disease progression, relapse or death of any cause. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date.
Measured: Up to 2 years
2 years progression-free survival Progression free survival
PFS is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment
Measured: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
2 years overall survival
Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.
Measured: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years
time to complete response within 24 months (TTCR24)
TTCR24 is defined as the time from randomization to first CR, and censored at 24 months
Measured: up to 2 years
complete response (CR) at 24 months
CR24 is defined as the CR rate at 24 months
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start11 Mar 2025
- Primary completion11 Sep 2027 (estimated)
- Study completion11 Sep 2029 (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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Model description
- Orelabrutinib combined with rituximab regimen
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Jiaxing University, Taizhou First People's Hospital, Huzhou Central Hospital, Zhejiang Cancer Hospital, Dongyang People's Hospital, Yuyao People's Hospital, Taizhou Hospital, Shaoxing Central Hospital, Affiliated Hospital of Jiaxing University, Shaoxing People's Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Central Hospital of Lishui City, Second Affiliated Hospital of Wenzhou Medical University, Ningbo People's Hospital, The People's Hospital of Quzhou, First Affiliated Hospital of Zhejiang University, Zhuji People's Hospital of Zhejiang Province
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022223
- Sponsor's protocol ID
- 2024-1336
- Status last verified
- Mar 2025
- First submitted
- 1 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma
- ClinicalTrials.gov ID
- NCT07022223
- Acronym / sponsor ID
- 2024-1336
- Conditions
- Marginal Zone Lymphoma(MZL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Jiaxing University, Taizhou First People's Hospital, Huzhou Central Hospital, Zhejiang Cancer Hospital, Dongyang People's Hospital, Yuyao People's Hospital, Taizhou Hospital, Shaoxing Central Hospital, Affiliated Hospital of Jiaxing University, Shaoxing People's Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Central Hospital of Lishui City, Second Affiliated Hospital of Wenzhou Medical University, Ningbo People's Hospital, The People's Hospital of Quzhou, First Affiliated Hospital of Zhejiang University, Zhuji People's Hospital of Zhejiang Province
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 11 Sep 2027 (estimated)
- Study completion
- 11 Sep 2029 (estimated)
- First posted
- 15 Jun 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 single-arm, prospective clinical study to evaluate the efficacy and safety of orelabrutinib combined with rituximab as first-line systemic treatment for marginal zone lymphoma.
Detailed description
Marginal zone lymphoma (MZL) is a relatively common type of B-cell non-Hodgkin lymphoma (B-NHL), with an incidence rate second only to diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). The Bruton tyrosine kinase (BTK) signaling pathway plays a significant role in B-cell malignancies. Most B-cell malignancies require activation of the B-cell receptor (BCR), and BTK, located downstream of the BCR, plays a crucial role in B-cell proliferation, apoptosis, differentiation, and migration induced by antigens. Currently, there is no unified treatment regimen with high-level evidence for the treatment of newly diagnosed MZL. As mentioned above, although high-intensity immunochemotherapy regimens achieve high response rates and durable remission, they also bring higher treatment-related safety risks (with a rate of grade 3 or higher adverse events of about 80%), including treatment-related deaths. Therefore, exploring effective chemotherapy-free regimens for MZL patients is a scientifically valuable and clinically meaningful attempt. Drugs such as BTK inhibitors and CD20 monoclonal antibodies have shown good therapeutic activity and clinical data as single agents. This is a single-arm, prospective clinical study to evaluate the efficacy and safety of orelabrutinib combined with rituximab as first-line systemic treatment for marginal zone lymphoma. All subjects will receive induction treatment with the orelabrutinib and rituximab regimen. The treatment cycle is 28 days, with a total of 6 cycles. Patients who achieve a partial response (PR) or better will enter a 2-year maintenance period with orelabrutinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Orelabrutinib combined with rituximab regimen
| Arm | Type | Receives |
|---|---|---|
| orelabrutinib combined with rituximab regimen | Experimental | Drug: orelabrutinib combined with rituximab regimenAll participants will receive induction therapy with the orelabrutinib and rituximab regimen. The treatment cycle is 28 days, with a total of 6 cycles. The induction treatment period is as follows: Cycle 1: Rituximab, 375 mg/m², on Day 1. Cycles 2-6:Orelabrutinib, 150 mg, once daily orally, from Day 1 to Day 28. Rituximab, 375 mg/m², on Day 1. Patients who achieve a partial response (PR) or better will enter a 2-year maintenance period with orelabrutinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years, regardless of gender;
- Histologically confirmed CD20-positive marginal zone lymphoma, including MALT, SMZL, and NMZL, with at least one lesion outside the spleen measuring more than 1.5 cm in any axis;
- MZL that has progressed or relapsed after prior local therapy (including surgery, radiotherapy, anti-Helicobacter pylori treatment, and anti-hepatitis C treatment), or is not suitable for local therapy;
- ECOG performance status of 0-2;
- Presence of an indication for treatment as judged by the investigator (symptomatic, cytopenia, risk of end-organ damage, bulky disease, ongoing progression, or patient's desire for treatment);
Key exclusion criteria (23 listed)
- Currently or previously having other malignancies, unless there is evidence of no recurrence or metastasis within the past 5 years after curative treatment;
- Lymphoma involvement of the central nervous system or transformation to high-grade lymphoma;
- Non-hematological toxicities from prior anti-cancer treatments not recovered to ≤ Grade 1 (excluding alopecia);
- Presence of uncontrolled or significant cardiovascular disease, including:
- New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months before the first administration of the study drug, or arrhythmias requiring treatment at screening, left ventricular ejection fraction (LVEF) < 50%;
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 combined with rituximab regimenAll participants will receive induction therapy with the orelabrutinib and rituximab regimen. The treatment cycle is 28 days, with a total of 6 cycles. The induction treatment period is as follows: Cycle 1: Rituximab, 375 mg/m², on Day 1. Cycles 2-6:Orelabrutinib, 150 mg, once daily orally, from Day 1 to Day 28. Rituximab, 375 mg/m², on Day 1. Patients who achieve a partial response (PR) or better will enter a 2-year maintenance period with orelabrutinib. | Drug | orelabrutinib combined with rituximab regimen |
Primary outcome
Overall Response Rate (ORR)
Time frame: up to 6 months
ORR is defined as the proportion of patients with a response of CR or PR
7 secondary outcomes
Complete Response Rate (CR)
Time frame: up to 6 months
Best Overall Response (BOR)
Time frame: up to 6 months
Duration of Response (DoR)
Time frame: Up to 2 years
2 years progression-free survival Progression free survival
Time frame: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
2 years overall survival
Time frame: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years
time to complete response within 24 months (TTCR24)
Time frame: up to 2 years
complete response (CR) at 24 months
Time frame: up to 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 15 Jun 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.
18 sites 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 combined with rituximab regimen in people with Marginal Zone Lymphoma(MZL), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 18 sites 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 11 inclusion and 23 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 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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?
Contact yun Liang (13957136178, liangyun@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: up to 6 months). 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 15 Jun 2025.