Marginal Zone Lymphoma(MZL)Phase 2NCT06793189
MZL-IPI Risk-adapted Targeted Therapy in Untreated MZL
A Phase 2 study testing Obinutuzumab and Orelabrutinib, Obinutuzumab, Orelabrutinib and Lenalidomide and Orelabrutinib in people with Marginal Zone Lymphoma(MZL), run by Ruijin Hospital at 3 sites in China.
Trial summary
Marginal zone lymphoma (MZL) is a common type of indolent lymphoma that originates from the marginal zone of lymphoid follicles. This study aims to evaluate targeted therapy based on the prognostic risk stratification of MZL-IPI in newly diagnosed MZL cases requiring systemic treatment, and provides a basis for… 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?
- Obinutuzumab and Orelabrutinib, Obinutuzumab, Orelabrutinib and Lenalidomide and Orelabrutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 3 sitesChina
- Study dates
- 23 Jan 2025to 31 Dec 2028
- 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
- 1. Histopathologically confirmed CD20-positive marginal zone lymphoma (according to the 2016 WHO classification).
- 2. Age ≥ 18 years old, regardless of gender. 3. MZL patients requiring systemic treatment, including but not limited to:
- Helicobacter pylori (HP)-positive or HP - negative gastric mucosa extranodal marginal zone lymphoma (MALT) patients with progression/relapse after local treatment (including surgery, radiotherapy, and anti - Helicobacter pylori treatment).
- Non - gastric MALT patients with Ann Arbor stage I - II who have progression/relapse after local treatment (including surgery, radiotherapy, etc.), or untreated patients with Ann Arbor stage III - IV who meet the GELF criteria recommended by the NCCN guidelines.
- Splenic marginal zone lymphoma (SMZL) patients with progression/relapse after local treatment (including splenectomy, antiviral treatment for HCV - positive patients, etc.), or untreated patients meeting the criteria of progressive or painful splenomegaly, symptomatic or progressive cytopenia such as HB < 100g/L, PLT < 80×10⁹/L, absolute neutrophil count (ANC) < 1.0×10⁹/L.
- Nodal marginal zone lymphoma (NMZL) patients with Ann Arbor stage I - II who have progression/relapse after local treatment (including surgery, radiotherapy, etc.), or untreated patients with Ann Arbor stage III - IV who meet the GELF criteria recommended by the NCCN guidelines.
- 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 5. Life expectancy of at least 3 months. 6. The patient has adequate bone marrow (except those caused by MZL), liver and kidney functions.
- 7. Able to comply with the research procedures and cooperate in the implementation of the entire research process; 8. Written informed consent; 9. Women with fertility agree to take appropriate measures to avoid pregnancy during the treatment period until at least one year after the end of treatment; Men agree to maintain abstinence or use barrier contraception.
Who cannot join
- 1. Histologically transformed into high-grade lymphoma. 2. Known central nervous system involvement of MZL. 3. Previous systemic treatment including immunotherapy, chemotherapy or targeted drugs.
- 4. Previous autologous stem-cell transplantation or allogeneic tissue/solid organ transplantation.
- 5. History of other invasive cancers within the past 3 years that have not received curative treatment or are still receiving anti-cancer treatment (including hormonal therapy for breast or prostate cancer).
- 6. Complicated with uncontrolled cardiovascular and cerebrovascular diseases (such as New York Heart Association-defined grade 3 or 4 heart failure, arrhythmia, myocardial infarction, stroke, or intracranial hemorrhage), coagulation - disorder diseases, connective tissue diseases, severe infectious diseases (including active pulmonary tuberculosis), etc.
- 7. Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (positive result shown by polymerase chain reaction [PCR]). Serological antibody - positive is allowed if HBV DNA < 10³ IU/ml; HCV RNA test must be negative.
- 8. Vaccinated with live attenuated vaccines within 4 weeks before starting investigational treatment. During the study, patients are prohibited from receiving live attenuated vaccine inoculations, including influenza vaccines.
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- 9. Requiring continuous treatment with potent and moderate-effect CYP3A inhibitors or CYP3A inducers.
- 10. Unable to swallow capsules or having diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction.
- 11. Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol.
- 12. Pregnant or lactating women. 13. Other concurrent and uncontrolled medical conditions that, in the investigator's opinion, will affect the patient's participation in the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Hongmei Jing, hongmeijing@bjmu.cn
- Recruiting
Shanghai Ruijin Hospital
Shanghai, China, 200025
Yujia Huo, 13302066917, zhao.weili@yahoo.com
- Recruiting
Affiliated First Hospital of China Medical University
Shenyang, Liaoning
Xiaojing Yan, yanxiaojing_pp@hotmail.com
About this study
Official title: A Prospective Study to Evaluate the Efficacy and Safety of MZL-IPI Risk-adapted Targeted Therapy in Patients With Untreated Marginal Zone B-cell Lymphoma
Marginal zone lymphoma (MZL) is a common type of indolent lymphoma that originates from the marginal zone of lymphoid follicles. This study aims to evaluate targeted therapy based on the prognostic risk stratification of MZL-IPI in newly diagnosed MZL cases requiring systemic treatment, and provides a basis for precision treatment of MZL.
- Conditions
- Marginal Zone Lymphoma(MZL)
- Being tested
- Obinutuzumab and Orelabrutinib, Obinutuzumab, Orelabrutinib and Lenalidomide, Orelabrutinib
- 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.
Obinutuzumab and OrelabrutinibDrug
Induction: Obinutuzumab (1000 mg on days 1, 8, and 15 of cycle 1; 1000 mg on day 1 of cycles 2-6, cycle length=21 days) and Orelabrutinib (150 mg once daily).
Obinutuzumab, Orelabrutinib and LenalidomideDrug
Induction: Obinutuzumab (1000 mg on days 1, 8, and 15 of cycle 1; 1000 mg on day 1 of cycles 2-6, cycle length=21 days), Orelabrutinib (150 mg once daily), and Lenalidomide (25 mg on days 2-11 of cycles 1-6, cycle length=21 days).
OrelabrutinibDrug
Maintenance: Orelabrutinib monotherapy (150 mg once daily up to 24 months).
OrelabrutinibDrug
Maintenance: Orelabrutinib monotherapy (150 mg once daily up to 24 months).
| Study group | Role | What they receive |
|---|---|---|
| Obinutuzumab and Orelabrutinib (O2) regimen | Experimental | Low-risk patients (MZL-IPI 0-2 points) |
| Obinutuzumab, Orelabrutinib and Lenalidomide (O2R) regimen | Experimental | High-risk patients (MZL-IPI 3-5 points) Receives: Drug: Obinutuzumab, Orelabrutinib and Lenalidomide; Drug: Orelabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival
Progression-free survival is defined as the time from registration to the first occurrence of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first; as assessed by the investigator.
Measured: Baseline up to data cut-off (up to 24 months).
Secondary outcomes (6)
Complete Response Rate after 6 cycles, at 12 months and 24 months
The proportion of patients with complete response after 6 cycles, 12 months and 24 months from treatment start, according to the 2014 Lugano Response Criteria.
Measured: At the end of cycle 6, at 12 months and 24 months after treatment start.
Overall Response Rate after 6 cycles, at 12 months and 24 months
The proportion of patients with complete and partial response after 6 cycles, 12 months and 24 months from treatment start, according to the 2014 Lugano Response Criteria.
Measured: At the end of cycle 6, at 12 months and 24 months after treatment start.
Treatment-Related Adverse Events rate as assessed by CTCAE version 5.0
Measured: From enrollment to study completion (up to approximately 24 months).
Duration of Response (DOR)
Duration of response is defined as the period from the first response (at least PR) to treatment until evidence of disease progression, relapse or death of any cause.
Measured: From enrollment to study completion (up to approximately 24 months).
Histological transformation rate
Histological transformation rate is defined as the proportion of patients with histological transformation.
Measured: From enrollment to study completion (up to approximately 24 months).
2-year overall survival
Overall survival is defined as the time from registration to death from any cause.
Measured: Baseline up to data cut-off (up 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 posted27 Jan 2025
- Study start23 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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 Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793189
- Sponsor's protocol ID
- MAGIC
- Status last verified
- Mar 2026
- First submitted
- 20 Jan 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Efficacy and Safety of MZL-IPI Risk-adapted Targeted Therapy in Patients With Untreated Marginal Zone B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06793189
- Acronym / sponsor ID
- MAGIC
- Conditions
- Marginal Zone Lymphoma(MZL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Jan 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.
Marginal zone lymphoma (MZL) is a common type of indolent lymphoma that originates from the marginal zone of lymphoid follicles. This study aims to evaluate targeted therapy based on the prognostic risk stratification of MZL-IPI in newly diagnosed MZL cases requiring systemic treatment, and provides a basis for precision treatment of MZL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obinutuzumab and Orelabrutinib (O2) regimen | Experimental | –Low-risk patients (MZL-IPI 0-2 points) |
| Obinutuzumab, Orelabrutinib and Lenalidomide (O2R) regimen | Experimental | Drug: Obinutuzumab, Orelabrutinib and Lenalidomide, Drug: OrelabrutinibHigh-risk patients (MZL-IPI 3-5 points) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Histopathologically confirmed CD20-positive marginal zone lymphoma (according to the 2016 WHO classification).
- 2. Age ≥ 18 years old, regardless of gender. 3. MZL patients requiring systemic treatment, including but not limited to:
- 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 5. Life expectancy of at least 3 months. 6. The patient has adequate bone marrow (except those caused by MZL), liver and kidney functions.
- 7. Able to comply with the research procedures and cooperate in the implementation of the entire research process; 8. Written informed consent; 9. Women with fertility agree to take appropriate measures to avoid pregnancy during the treatment period until at least one year after the end of treatment; Men agree to maintain abstinence or use barrier contraception.
Key exclusion criteria (10 listed)
- 1. Histologically transformed into high-grade lymphoma. 2. Known central nervous system involvement of MZL. 3. Previous systemic treatment including immunotherapy, chemotherapy or targeted drugs.
- 4. Previous autologous stem-cell transplantation or allogeneic tissue/solid organ transplantation.
- 5. History of other invasive cancers within the past 3 years that have not received curative treatment or are still receiving anti-cancer treatment (including hormonal therapy for breast or prostate cancer).
- 6. Complicated with uncontrolled cardiovascular and cerebrovascular diseases (such as New York Heart Association-defined grade 3 or 4 heart failure, arrhythmia, myocardial infarction, stroke, or intracranial hemorrhage), coagulation - disorder diseases, connective tissue diseases, severe infectious diseases (including active pulmonary tuberculosis), etc.
- 7. Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (positive result shown by polymerase chain reaction [PCR]). Serological antibody - positive is allowed if HBV DNA < 10³ IU/ml; HCV RNA test must be negative.
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 |
|---|---|---|
| Obinutuzumab and OrelabrutinibInduction: Obinutuzumab (1000 mg on days 1, 8, and 15 of cycle 1; 1000 mg on day 1 of cycles 2-6, cycle length=21 days) and Orelabrutinib (150 mg once daily). | Drug | – |
| Obinutuzumab, Orelabrutinib and LenalidomideInduction: Obinutuzumab (1000 mg on days 1, 8, and 15 of cycle 1; 1000 mg on day 1 of cycles 2-6, cycle length=21 days), Orelabrutinib (150 mg once daily), and Lenalidomide (25 mg on days 2-11 of cycles 1-6, cycle length=21 days). | Drug | Obinutuzumab, Orelabrutinib and Lenalidomide (O2R) regimen |
| OrelabrutinibMaintenance: Orelabrutinib monotherapy (150 mg once daily up to 24 months). | Drug | – |
| OrelabrutinibMaintenance: Orelabrutinib monotherapy (150 mg once daily up to 24 months). | Drug | Obinutuzumab, Orelabrutinib and Lenalidomide (O2R) regimen |
Primary outcome
2-year progression-free survival
Time frame: Baseline up to data cut-off (up to 24 months).
Progression-free survival is defined as the time from registration to the first occurrence of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first; as assessed by the investigator.
6 secondary outcomes
Complete Response Rate after 6 cycles, at 12 months and 24 months
Time frame: At the end of cycle 6, at 12 months and 24 months after treatment start.
Overall Response Rate after 6 cycles, at 12 months and 24 months
Time frame: At the end of cycle 6, at 12 months and 24 months after treatment start.
Treatment-Related Adverse Events rate as assessed by CTCAE version 5.0
Time frame: From enrollment to study completion (up to approximately 24 months).
Duration of Response (DOR)
Time frame: From enrollment to study completion (up to approximately 24 months).
Histological transformation rate
Time frame: From enrollment to study completion (up to approximately 24 months).
2-year overall survival
Time frame: Baseline up to data cut-off (up 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 24 Mar 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.
3 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 Obinutuzumab and Orelabrutinib, Obinutuzumab, Orelabrutinib and Lenalidomide and Orelabrutinib in people with Marginal Zone Lymphoma(MZL), run by Ruijin Hospital at 3 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 8 inclusion and 10 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Weili Zhao (+862164370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression-free survival (time frame: Baseline up to data cut-off (up 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 24 Mar 2026.