Rituximab Maintenance Versus Observation After R2 Induction in Previously Untreated Marginal Zone… (NCT07654465) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Rituximab Maintenance Versus Observation After R2 Induction in Previously Untreated Marginal Zone Lymphoma
China144 participantsStarted 2026-07
Plain-language 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. Patients who achieve complete response or partial response after R2 induction will be randomized to receive rituximab maintenance or observation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing rituximab maintenance after R2 induction for marginal zone lymphoma — could you walk me through what the R2 induction regimen actually involves, and whether my specific subtype of MZL would even be a candidate for this approach?
2Since this is a Phase 2 trial, what does that mean for how much is already known about the safety and effectiveness of rituximab maintenance in this setting, compared to what I might get with standard treatment options right now?
3The trial is not yet recruiting — how long do you think it might be before it opens, and is it worth waiting to see if I become eligible, or should we consider starting treatment sooner given my current condition?
4The main thing this trial is measuring is whether people are still progression-free at two years — based on where my disease stands today, do you think that's a realistic and meaningful goal for me specifically?
5Are there already approved or standard maintenance strategies for marginal zone lymphoma that I should weigh against enrolling in this trial, and what would I be giving up or gaining by choosing one path over the other?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.