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New hope for lymphoma patients: targeted therapy trial launches

NCT ID NCT07355699

Disease control Sponsor: Beijing Tongren Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a drug called orelabrutinib, alone or with another drug (CD20 antibody), in 88 people with untreated marginal zone lymphoma. The goal is to see how well the treatment shrinks or controls the cancer. Participants take the drug daily for 6 cycles, and those with more advanced disease also get an infusion. This is not a cure, but aims to manage the disease.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 88 people

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

Started

Nov 2025

Expected to finish

Dec 2028

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: * Age ≥ 18 years; * Pathologically confirmed marginal zone lymphoma; * Presence of evaluable lesions; * Meets indications for treatment: Fulfills the GELF criteria OR has disease-related clinical symptoms/organ function impairment; * Patients who are unsuitable for local radiotherapy, refuse local radiotherapy, or have disease progression after local therapy. Cases considered unsuitable for local radiotherapy include the following: Gastric MALT MZL, Ann Arbor stage I, that is H. pylori-negative, or H. pylori-positive gastric MALT MZL (Ann Arbor stage I) with poor response to H. pylori eradication therapy; Non-gastric MALT and nodal MZL in Ann Arbor non-contiguous stage II or stages III-IV; SMZL; Gastric MALT classified as Lugano II2, IIE, or IV stage; Patient intolerance to radiotherapy; Other MZL patients deemed unsuitable for local radiotherapy by the investigator. * ECOG score of 0-3; * Expected survival time ≥ 3 months; * Ability to provide signed informed consent. Exclusion Criteria: * Currently diagnosed with another malignant tumor; * Central nervous system involvement by lymphoma or transformation to a higher grade; * Allergy to any of the investigational drugs; * Active infection or uncontrolled HBV infection, HIV/AIDS, or other serious infectious diseases; * Pregnancy, lactating women, or subjects of childbearing potential unwilling to use contraception; * Other situations deemed by the investigator as unsuitable for participation in this trial.

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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

    3 sites. 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

  • Beijing Tongren Hospital

    RECRUITING

    Beijing, China

  • Peking Union Medical College Hospital

    NOT_YET_RECRUITING

    Beijing, China

  • The First Affiliated Hospital of China Medical University

    NOT_YET_RECRUITING

    Beijing, China

More trials for these conditions

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