Orelabrutinib alone or with a CD20 antibody for people newly diagnosed with marginal zone lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm, phase 4 study enrolls treatment-naïve adults with pathologically confirmed marginal zone lymphoma and assigns therapy based on stage and clinical features. Patients with Stage I disease receive orelabrutinib monotherapy (150 mg once daily, days 1–21 of each cycle for six cycles), while those with Stage II–IV disease receive orelabrutinib combined with a CD20 monoclonal antibody per protocol. Tumor response is measured by overall and complete response rates using imaging and laboratory tests, and safety is recorded through detailed adverse event monitoring. Long-term follow-up will track progression-free and overall survival to determine whether a chemotherapy-free regimen provides durable benefit.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Tongren Hospital
  Beijing, China Recruiting
• Peking Union Medical College Hospital
  Beijing, China Not yet recruiting
• The First Affiliated Hospital of China Medical University
  Beijing, China Not yet recruiting

Study contacts

• Principal investigator: Liang Wang, MD — Beijing Tongren Hospital
• Study coordinator: Liang Wang, MD
• Email: wangliangtrhos@126.com
• Phone: +86 15013009093

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Orelabrutinib plus rituximab with optional lenalidomide for untreated marginal zone lymphoma using a response-adapted plan

  This will test whether giving orelabrutinib with rituximab, and adding lenalidomide for those who don't fully respond, helps people with newly diagnosed marginal zone lymphoma achieve complete remissions.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07448324

• Orelabrutinib plus zebetuzumab and lenalidomide vs bendamustine‑rituximab for newly diagnosed marginal zone lymphoma

  This study will test whether a combination of orelabrutinib, zebetuzumab, and lenalidomide helps people with newly diagnosed marginal zone lymphoma compared with a standard bendamustine plus rituximab regimen.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07208981

• First-line treatment with orelabrutinib plus rituximab for marginal zone lymphoma

  This will test whether taking orelabrutinib together with rituximab works and is safe as a first systemic treatment for adults with marginal zone lymphoma.

  Recruiting at 18 sites Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang and 17 other locations · NCT07022223

• Orelabrutinib plus rituximab versus R‑CVP as first-line treatment for marginal zone lymphoma

  This test will see if orelabrutinib plus rituximab, followed by orelabrutinib maintenance, works as well or better than standard R‑CVP chemotherapy for adults with untreated marginal zone lymphoma.

  Recruiting Phase 2 The First Affiliated Hospital of Nanchang University · Nanchang, Jiangxi · NCT06700798

• Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL

  This trial tests whether adding orelabrutinib to the Pola-R-CHP regimen can improve outcomes for adults with intermediate- to high-risk newly diagnosed DLBCL.

  Recruiting at 2 sites The First Affiliated Hospital of Xiamen University · Xiamen, Fujian and 1 other locations · NCT07778212

• Orelabrutinib with Obinutuzumab and Short-Course Venetoclax in Treatment-Naïve Mantle Cell Lymphoma

  This trial tests whether a combo of orelabrutinib, obinutuzumab, and a short course of venetoclax is safe and effective for adults with newly diagnosed mantle cell lymphoma.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.