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Can a maintenance drug keep lymphoma at bay? new trial aims to find out.

NCT ID NCT07654465

Disease control Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether giving rituximab maintenance therapy after initial treatment with rituximab and lenalidomide (R2) can improve outcomes for people with untreated marginal zone lymphoma. About 144 patients who respond to R2 will be randomly assigned to receive rituximab every 8 weeks for 2 years or just observation. The main goal is to see if maintenance therapy extends the time without the disease getting worse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rituximab and lenalidomide
What this could lead to
If successful, this could show that maintenance therapy with rituximab helps keep marginal zone lymphoma in check longer after initial treatment.
What could go wrong
This is a phase 2 trial with only 144 participants, so results are preliminary. The maintenance therapy may not improve outcomes and could increase side effects like infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Lymphoma, B-Cell, Marginal Zone marginal zone lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Marginal zone lymphoma (MZL)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sun yat-sen university cancer center

    Guangzhou, Guangdong, 510060, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.