Orelabrutinib for adults with early-stage untreated 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 is a single-arm, multicenter, prospective phase II trial enrolling treatment‑naïve adults with histologically confirmed stage I–II marginal zone lymphoma. Participants receive oral orelabrutinib with scheduled clinical and laboratory monitoring to track response and adverse events. The study's primary objectives are to measure anti-lymphoma activity and safety in this population. Trial sites are located at major cancer centers across China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years, regardless of gender;
2. Patients with histopathologically confirmed stage I/II marginal zone lymphoma;
3. ECOG performance status score of 0-2;
4. Major organ functions meeting the following criteria:

   1. Blood tests: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow involvement, ANC ≥1.0×10\^9/L, platelets ≥50×10\^9/L, hemoglobin ≥50g/L;
   2. Blood biochemistry: Total bilirubin ≤1.5×ULN, AST or ALT ≤2×ULN; serum creatinine ≤1.5×ULN;
5. Coagulation function: International normalized ratio (INR) ≤1.5×ULN;
6. Expected survival time ≥12 months;
7. Voluntary written informed consent signed before trial screening.

Exclusion Criteria:

1. Lymphoma involving the central nervous system or transformation to high-grade;
2. Uncontrolled or significant cardiovascular diseases, including:

   1. New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose of the study drug, or arrhythmia requiring treatment at screening, with left ventricular ejection fraction (LVEF) \<50%;
   2. Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, or unclassified cardiomyopathy);
   3. History of clinically significant QTc interval prolongation, or QTc interval \>470 ms for females or \>450 ms for males at screening;
   4. Subjects with symptomatic coronary artery disease requiring medication;
   5. Poorly controlled hypertension (failure to achieve target blood pressure after at least one month of lifestyle modification and treatment with three or more antihypertensive drugs, including diuretics, at maximally tolerated doses, or requiring four or more antihypertensive drugs for effective control).
3. Active bleeding within 2 months prior to screening, or current use of anticoagulants, or investigator-determined clear bleeding tendency;
4. History of deep vein thrombosis or pulmonary embolism within the past six months;
5. Urine protein ≥2+ and 24-hour urine protein quantification ≥2 g/24 hours;
6. Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or subjects with total gastrectomy;
7. Current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or other conditions affecting lung function;
8. Pregnant or breastfeeding women, or subjects of childbearing potential unwilling to use contraception;
9. Continuous use of drugs with moderate to strong cytochrome P450 CYP3A inhibition or strong induction effects;
10. Other conditions deemed by the investigator as unsuitable for participation in this trial.

Where it's running

• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Xiangyang Central Hospital
  Xiangyang, Hubei, China Recruiting
• The Second Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting
• Jiangsu Province People's Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Shuhua yi — Hematology Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Shuhua Yi
• Email: yishuhua@ihcams.ac.cn
• Phone: 022-23909035

Similar studies

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

• Orelabrutinib and Obinutuzumab for Treating Marginal Zone Lymphoma

  This study is testing a new treatment combining Orelabrutinib and Obinutuzumab for people with previously untreated Marginal Zone Lymphoma to see if it works better and is safer than traditional chemotherapy.

  Recruiting Phase 2 Huai'an First People's Hospital · Huai'an, Jiangsu · NCT06566807

• Orelabrutinib combined with BR/G for untreated Marginal Zone Lymphoma

  This study is testing if a new drug called Orelabrutinib, combined with other treatments, can help younger and older patients with untreated Marginal Zone Lymphoma feel better and have fewer side effects.

  Recruiting Phase 2 First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT06504940

• Combining Orelabrutinib and Rituximab for Treating Marginal Zone Lymphoma

  This study is testing if combining two medications, Orelabrutinib and Rituximab, can help adults with Marginal Zone Lymphoma who haven't responded to other treatments or can't have local therapy.

  Recruiting The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT06478472

• Combination treatment for marginal zone lymphoma

  This study is testing a new combination of three medications to see if it can help people with untreated marginal zone lymphoma get better.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT06454968

• 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.

  Recruiting at 2 sites Phase 2 The First Affiliated Hospital with Nanjing Medical University · Changzhou, Jiangsu and 1 other locations · NCT07719556

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.