Marginal Zone Lymphoma(MZL)Phase 2ROMANCT07654465
Rituximab Maintenance Versus Observation After R2 Induction in Previously Untreated Marginal Zone Lymphoma
A Phase 2 study testing Rituximab and Observation in people with Marginal Zone Lymphoma(MZL), run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a multicenter, phase 2, randomized trial to compare rituximab maintenance with observation after rituximab and lenalidomide (R2) induction therapy in patients with previously untreated 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?
- Rituximab and Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and voluntarily sign the informed consent form.
- Age ≥18 years.
- Histologically confirmed CD20-positive marginal zone lymphoma, including extranodal, splenic, or nodal subtypes.
- Considered unsuitable for or unable to tolerate standard chemotherapy.
- Previously untreated with systemic anti-lymphoma therapy.
- Measurable or evaluable disease according to Lugano 2014 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate organ function.
Who cannot join
- History of other malignancies that may interfere with study assessment.
- Central nervous system involvement by lymphoma.
- Known HIV infection or active hepatitis B/C infection.
- Active or uncontrolled infection.
- Gastrointestinal condition that may interfere with oral administration or absorption of study treatment.
- Pregnancy or breastfeeding.
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
Sun yat-sen university cancer center
Guangzhou, Guangdong, 510060
Principal investigator, 0086-20-87342823, caiqq@sysucc.org.cn
About this study
Official title: Rituximab Maintenance Versus Observation After Rituximab and Lenalidomide (R2) Induction in Previously Untreated Marginal Zone Lymphoma: A Multicenter, Phase 2, Randomized Trial
This is a multicenter, phase 2, randomized trial to compare rituximab maintenance with observation after rituximab and lenalidomide (R2) induction therapy in patients with previously untreated marginal zone lymphoma. Patients who achieve complete response or partial response after R2 induction will be randomized to receive rituximab maintenance or observation.
- Conditions
- Marginal Zone Lymphoma(MZL)
- Being tested
- Rituximab, Observation
- 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.
RituximabDrug
Patients will receive R2 induction therapy consisting of rituximab and lenalidomide. Patients who achieve complete response or partial response after induction will receive rituximab maintenance every 8 weeks for up to 2 years.
ObservationOther
Patients will receive R2 induction therapy consisting of rituximab and lenalidomide. Patients who achieve complete response or partial response after induction will undergo observation without maintenance anti-lymphoma therapy.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Patients will receive induction therapy with rituximab and lenalidomide. If CR or PR: maintenance therapy with rituximab every 8 weeks for 2 years. Receives: Drug: Rituximab |
| Observation | Active comparator | Patients will receive induction therapy with rituximab and lenalidomide. If CR or PR: observation. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival rate
The 2-year progression-free survival rate is defined as the proportion of patients who are alive without disease progression at 2 years after randomization.
Measured: At 2 years after randomization
Secondary outcomes (9)
Complete response rate
Complete response rate is defined as the proportion of patients who achieve complete response according to the Lugano 2014 criteria during the maintenance or observation period.
Measured: Up to 24 months after randomization
Overall response rate
Overall response rate is defined as the proportion of patients who achieve complete response or partial response according to the Lugano 2014 criteria during the maintenance or observation period.
Measured: Up to 24 months after randomization
Duration of response
Duration of response is defined as the time from the first documented complete response or partial response to disease progression, relapse, or death from any cause, whichever occurs first.
Measured: Up to 24 months after randomization
Overall survival
Overall survival is defined as the time from randomization to death from any cause.
Measured: Up to 24 months after randomization
Event-free survival
Event-free survival is defined as the time from randomization to disease progression, relapse, initiation of new systemic anti-lymphoma therapy, or death from any cause, whichever occurs first.
Measured: Up to 24 months after randomization
Disease-free survival
Disease-free survival is defined as the time from the first documented complete response to disease relapse, progression, or death from any cause, whichever occurs first.
Measured: Up to 24 months after randomization
Incidence of progression of disease within 24 months
POD24 is defined as the proportion of patients who experience disease progression, relapse, or death from any cause within 24 months from the start of frontline induction therapy.
Measured: Within 24 months from the start of induction therapy
Patient-reported outcomes
Patient-reported outcomes will be assessed using the EORTC QLQ-C30 questionnaire.
Measured: Up to 24 months after randomization
Incidence of adverse events and serious adverse events
The incidence and severity of adverse events and serious adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 30 days after the last study treatment or during follow-up as clinically indicated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 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 Sun Yat-sen 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654465
- Sponsor's protocol ID
- B2026-335
- Acronym
- ROMA
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab Maintenance Versus Observation After Rituximab and Lenalidomide (R2) Induction in Previously Untreated Marginal Zone Lymphoma: A Multicenter, Phase 2, Randomized Trial
- ClinicalTrials.gov ID
- NCT07654465
- Acronym / sponsor ID
- ROMA / B2026-335
- Conditions
- Marginal Zone Lymphoma(MZL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, phase 2, randomized trial to compare rituximab maintenance with observation after rituximab and lenalidomide (R2) induction therapy in patients with previously untreated marginal zone lymphoma. Patients who achieve complete response or partial response after R2 induction will be randomized to receive rituximab maintenance or observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: RituximabPatients will receive induction therapy with rituximab and lenalidomide. If CR or PR: maintenance therapy with rituximab every 8 weeks for 2 years. |
| Observation | Active comparator | Other: ObservationPatients will receive induction therapy with rituximab and lenalidomide. If CR or PR: observation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to understand and voluntarily sign the informed consent form.
- Age ≥18 years.
- Histologically confirmed CD20-positive marginal zone lymphoma, including extranodal, splenic, or nodal subtypes.
- Considered unsuitable for or unable to tolerate standard chemotherapy.
- Previously untreated with systemic anti-lymphoma therapy.
Key exclusion criteria (6 listed)
- History of other malignancies that may interfere with study assessment.
- Central nervous system involvement by lymphoma.
- Known HIV infection or active hepatitis B/C infection.
- Active or uncontrolled infection.
- Gastrointestinal condition that may interfere with oral administration or absorption of study treatment.
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 |
|---|---|---|
| RituximabPatients will receive R2 induction therapy consisting of rituximab and lenalidomide. Patients who achieve complete response or partial response after induction will receive rituximab maintenance every 8 weeks for up to 2 years. | Drug | Rituximab |
| ObservationPatients will receive R2 induction therapy consisting of rituximab and lenalidomide. Patients who achieve complete response or partial response after induction will undergo observation without maintenance anti-lymphoma therapy. | Other | Observation |
Primary outcome
2-year progression-free survival rate
Time frame: At 2 years after randomization
The 2-year progression-free survival rate is defined as the proportion of patients who are alive without disease progression at 2 years after randomization.
9 secondary outcomes
Complete response rate
Time frame: Up to 24 months after randomization
Overall response rate
Time frame: Up to 24 months after randomization
Duration of response
Time frame: Up to 24 months after randomization
Overall survival
Time frame: Up to 24 months after randomization
Event-free survival
Time frame: Up to 24 months after randomization
Disease-free survival
Time frame: Up to 24 months after randomization
Incidence of progression of disease within 24 months
Time frame: Within 24 months from the start of induction therapy
Patient-reported outcomes
Time frame: Up to 24 months after randomization
Incidence of adverse events and serious adverse events
Time frame: Up to 30 days after the last study treatment or during follow-up as clinically indicated
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 17 Jun 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.
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 Rituximab and Observation in people with Marginal Zone Lymphoma(MZL), run by Sun Yat-sen 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 8 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Jun 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?
Contact Cai Qingqing ((020)87342823, caiqq@sysucc.org.cn), 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 rate (time frame: At 2 years after randomization). 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 17 Jun 2026.