Marginal Zone Lymphoma(MZL)Phase 2NCT07480863
Treatment of Orelabrutinib+Hi-CVP Regimen for Previously Untreated MZL
A Phase 2 study testing Orelabrutinib, Zuberitamab and Cyclophosphamide in people with Marginal Zone Lymphoma(MZL), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
In patients with previously untreated Marginal zone lymphoma (MZL), a treatment regimen of Orelabrutinib,Zuberitamab combined with Cyclophosphamide,Vincristine,Prednisoneacetatetablets is planned to be used. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Marginal Zone Lymphoma(MZL)
- What is being tested?
- Orelabrutinib, Zuberitamab and Cyclophosphamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 2 Oct 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- ECOG performance status (PS) 0-2
- Expected survival of at least 12 weeks
- CD20-positive marginal zone lymphoma confirmed according to WHO 2022 lymphoma classification standards, including the three subtypes: nodal MZL, extranodal MZL, and splenic MZL
- Measurable lesions by contrast-enhanced computed tomography/magnetic resonance imaging (CT/MRI)
- Meet the NCCN guideline criteria for MZL treatment and have not previously received systemic therapy for MZL (excluding hormone therapy and anti-infective treatment)
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- Main organ function within normal limits, meeting the following criteria (excluding abnormalities caused by lymphoma):
- Hematology test standards:
- ANC ≥ 1.0 × 10^9/L
- PLT ≥ 75 × 10^9/L (for patients with confirmed bone marrow involvement: ≥ 50 × 10^9/L)
- Hb ≥ 80 g/L
- Biochemistry test standards:
- TBIL < 2 × ULN
- ALT and AST < 2.5 × ULN (for patients with liver involvement, ALT and AST < 5 × ULN)
- Endogenous creatinine clearance ≥ 40 ml/min (Cockcroft-Gault formula)
- Women of childbearing potential must use reliable contraception or have a negative pregnancy test (blood or urine) within 7 days prior to enrollment and agree to use appropriate contraception during the trial and for 8 weeks after the last dose of the study drug. For men, agreement to use appropriate contraception during the trial and for 8 weeks after the last dose of the study drug or previous surgical sterilization is required
- Subjects voluntarily agree to participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up
Who cannot join
- Patients with central nervous system involvement
- Patients with a history of or concurrent untreated malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer
- Patients with the following cardiovascular diseases: myocardial ischemia or myocardial infarction of grade II or above, uncontrolled arrhythmias (including QTc interval ≥450 ms for men, ≥470 ms for women); heart failure of NYHA class III-IV, or left ventricular ejection fraction (LVEF) <50% as indicated by cardiac ultrasonography; 4. Coagulation dysfunction (INR >1.5 or prothrombin time (PT) > ULN + 4 seconds, or APTT >1.5 ULN), bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy
- Arterial or venous thrombotic events occurring within 12 months prior to enrollment, such as cerebrovascular events (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism
- Known genetic or acquired bleeding or thrombotic disorders (e.g., hemophilia, coagulation disorders)
- Major surgery or severe traumatic injury, fracture, or ulceration within 4 weeks prior to enrollment
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- Factors significantly affecting oral drug absorption, such as dysphagia, chronic diarrhea, or intestinal obstruction
- Active infections requiring antimicrobial treatment (e.g., antibacterial or antiviral drugs, excluding chronic hepatitis B antiviral therapy or antifungal treatments); 10. Active hepatitis B (HBV DNA ≥2000 IU/mL or 104 copies/mL) or hepatitis C (HCV antibody positive and HCV RNA above the detection limit of the assay)
- History of substance abuse of psychiatric drugs that cannot be discontinued or mental disorders
- Participation in another anti-tumor drug clinical trial within 4 weeks prior to enrollment
- Treatment with strong CYP3A4 inhibitors within 7 days prior to enrollment, or treatment with strong CYP3A4 inducers within 12 days prior to enrollment
- Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to use effective contraception
- Other conditions that the investigator deems may affect the conduction of the clinical study or the assessment of study results
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, beijing,
Beijing
About this study
Official title: Orelabrutinib Combined With Anti-CD20 Monoclonal Antibody-CVP Regimen for the Treatment of Previously Untreated Marginal Zone Lymphoma:A Pospective, Multicenter, Open-label Phase II Clinical Study
In patients with previously untreated Marginal zone lymphoma (MZL), a treatment regimen of Orelabrutinib,Zuberitamab combined with Cyclophosphamide,Vincristine,Prednisoneacetatetablets is planned to be used.
Read the detailed description
This is an investigator-initiated, prospective, open-label, multicenter Phase II clinical trial evaluating the efficacy and safety of orelabrutinib in combination with anti-CD20 monoclonal antibody-CVP (rituximab or zebetutamab-cyclophosphamide-vincristine-prednisone) followed by orelabrutinib monotherapy maintenance in treatment-naïve patients with marginal zone lymphoma (MZL) .
The study aims to address the unmet clinical need for a highly effective, chemotherapy-free frontline regimen in MZL. While current standard immunochemotherapy regimens-such as bendamustine plus rituximab (BR) or R-CVP-demonstrate meaningful response rates, they are associated with high incidences (60-70%) of Grade 3-4 adverse events, compromising quality of life and long-term tolerability . Building upon promising retrospective data showing 90% ORR and 30% CR with orelabrutinib plus rituximab in frontline MZL , and robust single-agent activity in relapsed/refractory MZL (ORR 68.9%, CR 11.1%) , this trial introduces a novel sequential strategy:
Induction phase: 6 cycles of orelabrutinib (150 mg orally once daily) combined with anti-CD20 monoclonal antibody (375 mg/m² IV), cyclophosphamide (750 mg/m² IV), vincristine (1.4 mg/m² IV, max 2 mg), and prednisone (100 mg IV Days 1-5), administered per 3-week cycle ; Maintenance phase: 18 cycles (1.5 years) of orelabrutinib monotherapy (150 mg QD), extended up to 2 years total treatment duration.
A key scientific innovation lies in the prospective, serial assessment of measurable residual disease (MRD) using next-generation sequencing (NGS) of peripheral blood at three critical timepoints: baseline, end of induction, and 1 year after initiation of maintenance therapy . This exploratory objective seeks to determine whether MRD negativity correlates with prolonged progression-free survival (PFS), overall survival (OS), and critically, prevention of progression within 2 years (POD24)-the strongest prognostic factor in MZL, associated with median survival of only 3-5 years . While MRD has established predictive value in CLL and FL , its role in MZL remains investigational, with only limited retrospective evidence (e.g., 5-year PFS of 74.8% vs. 31.4% in MRD-negative vs. MRD-positive splenic MZL) .
The primary endpoint is the 2-year complete response rate (CR24), with secondary endpoints including ORR and CR at end of induction, 2-year PFS and OS, and MRD dynamics . The study plans to enroll 65 patients across multiple centers, with the lead site-National Cancer Center/CICAMS-enrolling 36 participants . Eligibility requires confirmed CD20⁺ MZL (nodal, extranodal, or splenic), measurable disease, ECOG PS 0-2, and fulfillment of NCCN-defined treatment indications . Exclusion criteria include CNS involvement, active HBV/HCV infection, significant cardiovascular comorbidities (e.g., QTc ≥450/470 ms, LVEF <50%), recent thromboembolic events, or major surgery within 4 weeks .
Safety monitoring adheres strictly to NCI-CTCAE v5.0, with comprehensive AE/SAE collection from first dose through ≥30 days post-last dose, and mandatory 24-hour reporting of SAEs to the sponsor (Beijing Innocare Pharma) and ethics committee
. All procedures comply with the Declaration of Helsinki (1996), China's Good Clinical Practice (GCP) regulations, and require prior approval by the Ethics Committee of The First Affiliated Hospital of Nanchang University . Data will be managed via validated EDC systems, analyzed using SAS 9.3+, and archived for ≥5 years per GCP requirements .
The trial is sponsored by the National Cancer Center/CICAMS, with drug supply provided by Beijing Innocare Pharma (orelabrutinib) and financial support from Zhejiang Borun Biopharmaceutical Co., Ltd. (zebetutamab) . It represents a collaborative effort involving CICAMS' Langfang and Shenzhen branches .
- Conditions
- Marginal Zone Lymphoma(MZL)
- Being tested
- Orelabrutinib, Zuberitamab, Cyclophosphamide, Vincristine, Prednisoneacetatetablets
- 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
Also called Orelabrutinib Tablets
After the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred.
ZuberitamabDrug
Also called Zebutumab
After the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred.
CyclophosphamideDrug
Also called Cytoxan, Endoxan
After the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred.
VincristineDrug
Also called VDS
After the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred.
PrednisoneacetatetabletsDrug
Also called Decadron
After the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Marginal zone lymphoma who are treatment-naive | Experimental | After the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred. Receives: Drug: Orelabrutinib; Drug: Zuberitamab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisoneacetatetablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-month complete remission rate
All visible tumor lesions have completely disappeared, no new lesions have appeared, and this has been maintained for at least 4 weeks at 24-month.
Measured: From enrollment to 24 months
Secondary outcomes (4)
Objective response rate (ORR) at the end of induction therapy
The overall response rate (ORR) was defined as the cumulative proportion of patients attaining either a complete response (CR) or partial response (PR) at the end of induction therapy .
Measured: From enrollment to the end of induction treatment at 8 weeks
Complete remission rate (CRR) at the end of induction therapy
All visible tumor lesions have completely disappeared, no new lesions have appeared, and this has been maintained for at least 4 weeks at the end of induction therapy.
Measured: From enrollment to the end of induction treatment at 8 weeks
24-month progression-free survival rate
PFS defined as the time from RD initiation to first documented disease progression, relapse after RD, death from any cause, or last follow-up at 24-month..
Measured: From enrollment to 24 months
24-Month Overall Survival Rate
OS was measured from RD start to death or last follow-up at 24-month.
Measured: From enrollment to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Oct 2025
- Primary completion1 Oct 2029 (estimated)
- Study completion2 Oct 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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- A multicenter, prospective, interventional study, with a planned number of subjects: approximately 65 cases.
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- InnoCare Pharma Inc., BioRay Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Xinxin Cao, doctor, Study chair, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480863
- Sponsor's protocol ID
- NCCH0037
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 2 Apr 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 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orelabrutinib Combined With Anti-CD20 Monoclonal Antibody-CVP Regimen for the Treatment of Previously Untreated Marginal Zone Lymphoma:A Pospective, Multicenter, Open-label Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07480863
- Acronym / sponsor ID
- NCCH0037
- Conditions
- Marginal Zone Lymphoma(MZL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- InnoCare Pharma Inc., BioRay Pharmaceutical Co., Ltd.
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 2 Oct 2029 (estimated)
- First posted
- 18 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.
In patients with previously untreated Marginal zone lymphoma (MZL), a treatment regimen of Orelabrutinib,Zuberitamab combined with Cyclophosphamide,Vincristine,Prednisoneacetatetablets is planned to be used.
Detailed description
This is an investigator-initiated, prospective, open-label, multicenter Phase II clinical trial evaluating the efficacy and safety of orelabrutinib in combination with anti-CD20 monoclonal antibody-CVP (rituximab or zebetutamab-cyclophosphamide-vincristine-prednisone) followed by orelabrutinib monotherapy maintenance in treatment-naïve patients with marginal zone lymphoma (MZL) .
The study aims to address the unmet clinical need for a highly effective, chemotherapy-free frontline regimen in MZL. While current standard immunochemotherapy regimens-such as bendamustine plus rituximab (BR) or R-CVP-demonstrate meaningful response rates, they are associated with high incidences (60-70%) of Grade 3-4 adverse events, compromising quality of life and long-term tolerability . Building upon promising retrospective data showing 90% ORR and 30% CR with orelabrutinib plus rituximab in frontline MZL , and robust single-agent activity in relapsed/refractory MZL (ORR 68.9%, CR 11.1%) , this trial introduces a novel sequential strategy:
Induction phase: 6 cycles of orelabrutinib (150 mg orally once daily) combined with anti-CD20 monoclonal antibody (375 mg/m² IV), cyclophosphamide (750 mg/m² IV), vincristine (1.4 mg/m² IV, max 2 mg), and prednisone (100 mg IV Days 1-5), administered per 3-week cycle ; Maintenance phase: 18 cycles (1.5 years) of orelabrutinib monotherapy (150 mg QD), extended up to 2 years total treatment duration.
A key scientific innovation lies in the prospective, serial assessment of measurable residual disease (MRD) using next-generation sequencing (NGS) of peripheral blood at three critical timepoints: baseline, end of induction, and 1 year after initiation of maintenance therapy . This exploratory objective seeks to determine whether MRD negativity correlates with prolonged progression-free survival (PFS), overall survival (OS), and critically, prevention of progression within 2 years (POD24)-the strongest prognostic factor in MZL, associated with median survival of only 3-5 years . While MRD has established predictive value in CLL and FL , its role in MZL remains investigational, with only limited retrospective evidence (e.g., 5-year PFS of 74.8% vs. 31.4% in MRD-negative vs. MRD-positive splenic MZL) .
The primary endpoint is the 2-year complete response rate (CR24), with secondary endpoints including ORR and CR at end of induction, 2-year PFS and OS, and MRD dynamics . The study plans to enroll 65 patients across multiple centers, with the lead site-National Cancer Center/CICAMS-enrolling 36 participants . Eligibility requires confirmed CD20⁺ MZL (nodal, extranodal, or splenic), measurable disease, ECOG PS 0-2, and fulfillment of NCCN-defined treatment indications . Exclusion criteria include CNS involvement, active HBV/HCV infection, significant cardiovascular comorbidities (e.g., QTc ≥450/470 ms, LVEF <50%), recent thromboembolic events, or major surgery within 4 weeks .
Safety monitoring adheres strictly to NCI-CTCAE v5.0, with comprehensive AE/SAE collection from first dose through ≥30 days post-last dose, and mandatory 24-hour reporting of SAEs to the sponsor (Beijing Innocare Pharma) and ethics committee
. All procedures comply with the Declaration of Helsinki (1996), China's Good Clinical Practice (GCP) regulations, and require prior approval by the Ethics Committee of The First Affiliated Hospital of Nanchang University . Data will be managed via validated EDC systems, analyzed using SAS 9.3+, and archived for ≥5 years per GCP requirements .
The trial is sponsored by the National Cancer Center/CICAMS, with drug supply provided by Beijing Innocare Pharma (orelabrutinib) and financial support from Zhejiang Borun Biopharmaceutical Co., Ltd. (zebetutamab) . It represents a collaborative effort involving CICAMS' Langfang and Shenzhen branches .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A multicenter, prospective, interventional study, with a planned number of subjects: approximately 65 cases.
| Arm | Type | Receives |
|---|---|---|
| Patients with Marginal zone lymphoma who are treatment-naive | Experimental | Drug: Orelabrutinib, Drug: Zuberitamab, Drug: Cyclophosphamide, Drug: Vincristine, Drug: PrednisoneacetatetabletsAfter the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age 18 years or older
- ECOG performance status (PS) 0-2
- Expected survival of at least 12 weeks
- CD20-positive marginal zone lymphoma confirmed according to WHO 2022 lymphoma classification standards, including the three subtypes: nodal MZL, extranodal MZL, and splenic MZL
- Measurable lesions by contrast-enhanced computed tomography/magnetic resonance imaging (CT/MRI)
Key exclusion criteria (13 listed)
- Patients with central nervous system involvement
- Patients with a history of or concurrent untreated malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer
- Patients with the following cardiovascular diseases: myocardial ischemia or myocardial infarction of grade II or above, uncontrolled arrhythmias (including QTc interval ≥450 ms for men, ≥470 ms for women); heart failure of NYHA class III-IV, or left ventricular ejection fraction (LVEF) <50% as indicated by cardiac ultrasonography; 4. Coagulation dysfunction (INR >1.5 or prothrombin time (PT) > ULN + 4 seconds, or APTT >1.5 ULN), bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy
- Arterial or venous thrombotic events occurring within 12 months prior to enrollment, such as cerebrovascular events (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism
- Known genetic or acquired bleeding or thrombotic disorders (e.g., hemophilia, coagulation disorders)
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 |
|---|---|---|
| OrelabrutinibAlso: Orelabrutinib TabletsAfter the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred. | Drug | Patients with Marginal zone lymphoma who are treatment-naive |
| ZuberitamabAlso: ZebutumabAfter the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred. | Drug | Patients with Marginal zone lymphoma who are treatment-naive |
| CyclophosphamideAlso: Cytoxan, EndoxanAfter the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred. | Drug | Patients with Marginal zone lymphoma who are treatment-naive |
| VincristineAlso: VDSAfter the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred. | Drug | Patients with Marginal zone lymphoma who are treatment-naive |
| PrednisoneacetatetabletsAlso: DecadronAfter the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred. | Drug | Patients with Marginal zone lymphoma who are treatment-naive |
Primary outcome
24-month complete remission rate
Time frame: From enrollment to 24 months
All visible tumor lesions have completely disappeared, no new lesions have appeared, and this has been maintained for at least 4 weeks at 24-month.
4 secondary outcomes
Objective response rate (ORR) at the end of induction therapy
Time frame: From enrollment to the end of induction treatment at 8 weeks
Complete remission rate (CRR) at the end of induction therapy
Time frame: From enrollment to the end of induction treatment at 8 weeks
24-month progression-free survival rate
Time frame: From enrollment to 24 months
24-Month Overall Survival Rate
Time frame: From enrollment to 24 months
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 2 Apr 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. This study is not recruiting at the moment.
Xinxin Cao, doctor study chair
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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, Zuberitamab and Cyclophosphamide in people with Marginal Zone Lymphoma(MZL), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 17 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-month complete remission rate (time frame: From enrollment to 24 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 2 Apr 2026.