Marginal Zone Lymphoma(MZL)Phase 2NCT07208981
Orelabrutinib Combined With Zebetuzumab and Lenalidomide for the Treatment of Newly Diagnosed MZL
A Phase 2 study testing Orelabrutinib, Zebetuzumab and Lenalidomide in people with Marginal Zone Lymphoma(MZL), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is an open-label, multicenter, phase 2, non-randomized study aiming to evaluate the efficacy and safety of orelabrutinib combined with zebetuzumab and lenalidomide or bendamustine combined with rituximab in the treatment of newly diagnosed marginal zone lymphoma (MZL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Marginal Zone Lymphoma(MZL)
- What is being tested?
- Orelabrutinib, Zebetuzumab and Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2025to 1 Jun 2031
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age 18-75 years, gender not restricted;
- 2. Histopathologically confirmed CD20-positive marginal zone lymphoma includes MALT, SMZL, and NMZL; at least one measurable lesion;
- 3. Indication for treatment
- 3.1. Initial diagnosis II 2 or IIE or IV stage gastric MALT treatment indications. Including: ① Meeting the inclusion criteria for clinical trials; ② Presence of lymphoma-related clinical symptoms; ③ Gastrointestinal bleeding (bleeding condition controlled or assessed by the investigator for suitability of inclusion); ④ End-organ damage; ⑤ Large mass; ⑥ Persistent or rapid disease progression; ⑦ Patient's willingness;
- 3.2. Recommendations for treatment indications of newly diagnosed stage III-IV non-gastric MALT and NMZL. The GELF criteria, similar to those used for follicular lymphoma, include: ① The presence of ≥3 distinct regions of involved lymph nodes, with each involved lymph node having a diameter of ≥3 cm; ② The presence of any lymph node or extranodal lesion with a diameter >7 cm; ③ The presence of B symptoms; ④ Splenomegaly; ⑤ Symptoms of organ compression, pleural or peritoneal effusion; ⑥ Cytopenia caused by the disease; ⑦ Persistent or rapid disease progression, with tumor size increasing by 20%-30% within 2-3 months or approximately 50% within 6 months; ⑧ Meeting the inclusion criteria for clinical trials;
- 3.3. Recommended indications for the treatment of newly diagnosed SMZL. Including: ① Progressive or painful splenomegaly; ② Symptomatic or progressive cytopenia such as HB<100g/L, PLT<80×10^9/L, absolute neutrophil count (ANC)<1.0×10^9/L (note to differentiate from cytopenia caused by autoimmune factors);
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- 4. Without prior systemic treatment, may include MZL (marginal zone lymphoma) that has progressed, relapsed, or is unsuitable for local treatment after previous local therapy (local treatment includes surgery, radiotherapy, anti-Helicobacter pylori therapy for at least 12 months, or anti-hepatitis C therapy);
- 5. ECOG performance status score 0-2 points
- 6. The main organ functions meet the following criteria (except for SMZL, which is judged separately by the investigator to meet treatment requirements): Complete blood count: Absolute neutrophil count ≥1.5×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow involvement, absolute neutrophil count ≥1.0×10^9/L, platelets ≥50×10^9/L, hemoglobin ≥50g/L; Blood biochemistry: Total bilirubin ≤ 1.5 times ULN, AST or ALT ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; serum amylase ≤ ULN; creatinine clearance rate ≥ 60 mL/min;
- 7. Coagulation function: International Normalized Ratio (INR) ≤1.5 times ULN;
- 8. Expected survival time ≥ 12 months;
- 9. Voluntarily sign a written informed consent before trial screening.
Who cannot join
- 1. Currently or previously diagnosed with other malignancies, unless radical treatment has been performed and there is evidence of no recurrence or metastasis within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, and localized squamous cell carcinoma of the skin;
- 2. Lymphoma involving the central nervous system or transforming to a higher grade;
- 3. Uncontrolled or significant cardiovascular diseases, including: a) Occurrence of New York Heart Association (NYHA) Class III-IV congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first administration of the investigational drug, or the presence of treatable arrhythmias at screening, with left ventricular ejection fraction (LVEF) <50%; b) Primary cardiomyopathies (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy); c) A clinically significant history of QTc interval prolongation, or QTc interval during the screening period >470ms for females and >450ms for males; d) Subjects with symptomatic or medication-requiring coronary heart disease; e) Suffering from uncontrolled hypertension (blood pressure remains uncontrolled after more than one month of using a reasonable and tolerable dosage of three or more antihypertensive drugs (including diuretics) based on lifestyle improvements, or blood pressure can only be effectively controlled by taking four or more antihypertensive drugs);
- 4. Active bleeding within 2 months prior to screening, or currently taking anticoagulants, or deemed by the investigator to have a clear bleeding tendency;
- 5. History of deep vein thrombosis or pulmonary embolism in the past six months;
- 6. Underwent major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening. Major surgery refers to procedures performed under general anesthesia, but endoscopic examinations for diagnostic purposes are not considered major surgery. The insertion of vascular access devices is exempt from this exclusion criterion;
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- 7. Active infection or uncontrolled HBV (HBsAg positive and/or HBcAb positive with HBV DNA titer positive), HCV RNA positive, HIV/AIDS, or other severe infectious diseases;
- 8. Currently, there are subjects with severe pulmonary function impairment due to conditions such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, and drug-related pneumonia: FEV1% or DLCO (or DLCO/VA) %pred < 40% (with severe pulmonary ventilation and gas exchange dysfunction);
- 9. Pregnant, lactating women and childbearing age subjects unwilling to use contraception;
- 10. Need to continuously take medications with moderate to strong inhibitory or strong inducing effects on cytochrome P450 CYP3A;
- 11. The investigator considers other conditions unsuitable for participating in this trial.
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 with Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Jianyong Li, PhD, MD, 86-13951877733, lijianyonglm@126.com
Huayuan Zhu, PhD, MD, 86-13813810650, huayuan.zhu@hotmail.com
About this study
Official title: A Prospective Multicenter Study of Orelabrutinib Combined With Zebetuzumab and Lenalidomide or Bendamustine Combined With Rituximab for the Treatment of Newly Diagnosed MZL
This is an open-label, multicenter, phase 2, non-randomized study aiming to evaluate the efficacy and safety of orelabrutinib combined with zebetuzumab and lenalidomide or bendamustine combined with rituximab in the treatment of newly diagnosed marginal zone lymphoma (MZL).
- Conditions
- Marginal Zone Lymphoma(MZL)
- Being tested
- Orelabrutinib, Zebetuzumab, Lenalidomide, Bendamustine + 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.
OrelabrutinibDrug
Induction treatment phase (a total of 6 cycles, each cycle lasting 28 days), Orelabrutinib (150 mg, d1-d28). Maintenance phase (a total of 24 cycles, each cycle lasting 28 days), Orelabrutinib (150 mg, d1-d28). Patients who achieve complete remission (CR) or partial remission (PR) after 6 cycles will decide whether to undergo maintenance therapy based on the investigator's choice.
ZebetuzumabDrug
Induction treatment phase (a total of 6 cycles, each cycle lasting 28 days), Zebetuzumab (375 mg/m2, d1/C1-C6).
LenalidomideDrug
Induction treatment phase (a total of 6 cycles, each cycle lasting 28 days), Lenalidomide (20 mg, d1-d21).
Bendamustine + RituximabDrug
Treatment period (a total of 6 cycles, each cycle lasting 28 days), Bendamustine (90 mg/m2, d1-2), Rituximab (375 mg/m2, d1/C1-6).
| Study group | Role | What they receive |
|---|---|---|
| Group of orelabrutinib combined with zebetuzumab and lenalidomide | Experimental | Not described Receives: Drug: Orelabrutinib; Drug: Zebetuzumab; Drug: Lenalidomide |
| Group of bendamustine combined with rituximab | Active comparator | Not described Receives: Drug: Bendamustine + Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year PFS rate
PFS is defined as the first dose of treatment to the date of first documented progression or date of death from any cause, whichever occurs first. 3-year PFS rate will be estimated by Kaplan-Meier.
Measured: From the first dose of treatment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 months.
Secondary outcomes (8)
Overall response rate (ORR)
Overall response rate is the proportion of patients who achieve either a complete or partial response to treatment defined by the Lugano classification criteria for lymphoma response evaluation (2014 edition)/GELA (gastric MALT).
Measured: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days).
Rate of best overall response (BOR)
The rate of best overall response is the proportion of patients who achieve their best recorded response (complete or partial) to treatment at any time during the study.
Measured: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days).
Time to response (TTR)
Time to response is the duration from the start of treatment to the first documentation of a complete or partial response.
Measured: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days).
Progression-free survival (PFS) rate
PFS is defined as the time from the first dose of treatment until the date of first documented progression or date of death from any cause, whichever occurs first. For subjects without progression, relapse, or death at the time of analysis, EFS will be censored at the last assessment date.
Measured: From the first dose of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 months.
Overall survival (OS) rate
OS is defined as the time from the first dose of treatment until the date of death from any cause, assessed up to 66 months. Subjects who remain alive at the time of analysis will be censored at the last known alive date of the subject.
Measured: From the first dose of treatment until the date of death from any cause, assessed up to 66 months.
Rate of progression of disease within 24 months (POD24)
Progression of disease within 24 months is defined as patients whose disease relapse or progress within 24 months of first treatment.
Measured: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days).
Quality of life (FACT-Lym)
FACT-Lym (Functional Assessment of Cancer Therapy-Lymphoma) is a validated questionnaire that measures health-related quality of life in patients with lymphoma, covering physical, social/family, emotional, and functional well-being, along with lymphoma-specific symptoms and concerns. FACT-Lym has 42 items, and scores of every item range from 0 to 4, with higher scores indicating better quality of life.
Measured: On Screening, Day 1 of Cycle 1, Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days).
Adverse Events
All treatment-emergent AEs will be included in the analysis. For each AE, the number and percentage of subjects who experience at least one occurrence of the given event will be summarized. The number and percent of subjects with TEAEs will be summarized according to intensity (CTCAE, v5) for hematologic toxicity, and drug relationship, as well as categorized by system organ class and preferred term. Summaries, listings, datasets, or subject narratives may be provided, as appropriate, for those subjects who die, who discontinue treatment due to an AE, or who experience a severe AE or a SAE.
Measured: From screening to 3 years after the end of maintenance therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start14 Aug 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2031 (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 with Nanjing Medical 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208981
- Sponsor's protocol ID
- Optional
- Status last verified
- Aug 2025
- First submitted
- 18 Sep 2025
- Last updated
- 6 Oct 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 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study of Orelabrutinib Combined With Zebetuzumab and Lenalidomide or Bendamustine Combined With Rituximab for the Treatment of Newly Diagnosed MZL
- ClinicalTrials.gov ID
- NCT07208981
- Acronym / sponsor ID
- Optional
- Conditions
- Marginal Zone Lymphoma(MZL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 169 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 6 Oct 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 an open-label, multicenter, phase 2, non-randomized study aiming to evaluate the efficacy and safety of orelabrutinib combined with zebetuzumab and lenalidomide or bendamustine combined with rituximab in the treatment of newly diagnosed marginal zone lymphoma (MZL).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of orelabrutinib combined with zebetuzumab and lenalidomide | Experimental | Drug: Orelabrutinib, Drug: Zebetuzumab, Drug: Lenalidomide |
| Group of bendamustine combined with rituximab | Active comparator | Drug: Bendamustine + Rituximab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Age 18-75 years, gender not restricted;
- 2. Histopathologically confirmed CD20-positive marginal zone lymphoma includes MALT, SMZL, and NMZL; at least one measurable lesion;
- 3. Indication for treatment
- 4. Without prior systemic treatment, may include MZL (marginal zone lymphoma) that has progressed, relapsed, or is unsuitable for local treatment after previous local therapy (local treatment includes surgery, radiotherapy, anti-Helicobacter pylori therapy for at least 12 months, or anti-hepatitis C therapy);
- 5. ECOG performance status score 0-2 points
Key exclusion criteria (11 listed)
- 1. Currently or previously diagnosed with other malignancies, unless radical treatment has been performed and there is evidence of no recurrence or metastasis within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, and localized squamous cell carcinoma of the skin;
- 2. Lymphoma involving the central nervous system or transforming to a higher grade;
- 3. Uncontrolled or significant cardiovascular diseases, including: a) Occurrence of New York Heart Association (NYHA) Class III-IV congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first administration of the investigational drug, or the presence of treatable arrhythmias at screening, with left ventricular ejection fraction (LVEF) <50%; b) Primary cardiomyopathies (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy); c) A clinically significant history of QTc interval prolongation, or QTc interval during the screening period >470ms for females and >450ms for males; d) Subjects with symptomatic or medication-requiring coronary heart disease; e) Suffering from uncontrolled hypertension (blood pressure remains uncontrolled after more than one month of using a reasonable and tolerable dosage of three or more antihypertensive drugs (including diuretics) based on lifestyle improvements, or blood pressure can only be effectively controlled by taking four or more antihypertensive drugs);
- 4. Active bleeding within 2 months prior to screening, or currently taking anticoagulants, or deemed by the investigator to have a clear bleeding tendency;
- 5. History of deep vein thrombosis or pulmonary embolism in the past six months;
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 |
|---|---|---|
| OrelabrutinibInduction treatment phase (a total of 6 cycles, each cycle lasting 28 days), Orelabrutinib (150 mg, d1-d28). Maintenance phase (a total of 24 cycles, each cycle lasting 28 days), Orelabrutinib (150 mg, d1-d28). Patients who achieve complete remission (CR) or partial remission (PR) after 6 cycles will decide whether to undergo maintenance therapy based on the investigator's choice. | Drug | Group of orelabrutinib combined with zebetuzumab and lenalidomide |
| ZebetuzumabInduction treatment phase (a total of 6 cycles, each cycle lasting 28 days), Zebetuzumab (375 mg/m2, d1/C1-C6). | Drug | Group of orelabrutinib combined with zebetuzumab and lenalidomide |
| LenalidomideInduction treatment phase (a total of 6 cycles, each cycle lasting 28 days), Lenalidomide (20 mg, d1-d21). | Drug | Group of orelabrutinib combined with zebetuzumab and lenalidomide |
| Bendamustine + RituximabTreatment period (a total of 6 cycles, each cycle lasting 28 days), Bendamustine (90 mg/m2, d1-2), Rituximab (375 mg/m2, d1/C1-6). | Drug | Group of bendamustine combined with rituximab |
Primary outcome
3-year PFS rate
Time frame: From the first dose of treatment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 months.
PFS is defined as the first dose of treatment to the date of first documented progression or date of death from any cause, whichever occurs first. 3-year PFS rate will be estimated by Kaplan-Meier.
8 secondary outcomes
Overall response rate (ORR)
Time frame: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days).
Rate of best overall response (BOR)
Time frame: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days).
Time to response (TTR)
Time frame: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days).
Progression-free survival (PFS) rate
Time frame: From the first dose of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 months.
Overall survival (OS) rate
Time frame: From the first dose of treatment until the date of death from any cause, assessed up to 66 months.
Rate of progression of disease within 24 months (POD24)
Time frame: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days).
Quality of life (FACT-Lym)
Time frame: On Screening, Day 1 of Cycle 1, Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 13, Day 1 of Cycle 19, Day 1 of Cycle 25, Day 1 of Cycle 31 (each cycle is 28 days).
Adverse Events
Time frame: From screening to 3 years after the end of maintenance therapy.
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 6 Oct 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.
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, Zebetuzumab and Lenalidomide in people with Marginal Zone Lymphoma(MZL), run by The First Affiliated Hospital with Nanjing Medical 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 12 inclusion and 11 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 6 Oct 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.
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 Jianyong Li, PhD, MD (86-13951877733, lijianyonglm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year PFS rate (time frame: From the first dose of treatment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 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 6 Oct 2025.