[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"marginal-zone-lymphomamzl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:marginal-zone-lymphomamzl":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,41,64,85,110,132,152,175,197],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100642209","phase-2-rituximab-maintenance-versus-observation-after-r2-induction-in-previously-untreated-marginal-zone-lymphoma-100642209",false,"NCT07654465","Rituximab Maintenance Versus Observation After R2 Induction in Previously Untreated Marginal Zone Lymphoma","Rituximab Maintenance Versus Observation After Rituximab and Lenalidomide (R2) Induction in Previously Untreated Marginal Zone Lymphoma: A Multicenter, Phase 2, Randomized Trial","ROMA","Inclusion Criteria:\n\n* Able to understand and voluntarily sign the informed consent form.\n* Age ≥18 years.\n* Histologically confirmed CD20-positive marginal zone lymphoma, including extranodal, splenic, or nodal subtypes.\n* Considered unsuitable for or unable to tolerate standard chemotherapy.\n* Previously untreated with systemic anti-lymphoma therapy.\n* Measurable or evaluable disease according to Lugano 2014 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* History of other malignancies that may interfere with study assessment.\n* Central nervous system involvement by lymphoma.\n* Known HIV infection or active hepatitis B\u002FC infection.\n* Active or uncontrolled infection.\n* Gastrointestinal condition that may interfere with oral administration or absorption of study treatment.\n* Pregnancy or breastfeeding.","ALL","18 Years",{"count":20,"type":21},144,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.",[27],"Marginal Zone Lymphoma(MZL)","NOT_YET_RECRUITING","2026-06-12",{"date":31,"type":32},"2026-06-17","ACTUAL",{"date":34,"type":21},"2026-07",{"date":36,"type":21},"2031-07",{"name":38,"class":39},"Sun Yat-sen University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":63},"100577045","phase-2-mzl-ipi-risk-adapted-targeted-therapy-in-untreated-mzl-100577045","NCT06793189","MZL-IPI Risk-adapted Targeted Therapy in Untreated MZL","A Prospective Study to Evaluate the Efficacy and Safety of MZL-IPI Risk-adapted Targeted Therapy in Patients With Untreated Marginal Zone B-cell Lymphoma","Inclusion Criteria:\n\n* 1\\. Histopathologically confirmed CD20-positive marginal zone lymphoma (according to the 2016 WHO classification).\n\n  2\\. Age ≥ 18 years old, regardless of gender. 3. MZL patients requiring systemic treatment, including but not limited to:\n  1. Helicobacter pylori (HP)-positive or HP - negative gastric mucosa extranodal marginal zone lymphoma (MALT) patients with progression\u002Frelapse after local treatment (including surgery, radiotherapy, and anti - Helicobacter pylori treatment).\n  2. Non - gastric MALT patients with Ann Arbor stage I - II who have progression\u002Frelapse after local treatment (including surgery, radiotherapy, etc.), or untreated patients with Ann Arbor stage III - IV who meet the GELF criteria recommended by the NCCN guidelines.\n  3. Splenic marginal zone lymphoma (SMZL) patients with progression\u002Frelapse after local treatment (including splenectomy, antiviral treatment for HCV - positive patients, etc.), or untreated patients meeting the criteria of progressive or painful splenomegaly, symptomatic or progressive cytopenia such as HB \\\u003C 100g\u002FL, PLT \\\u003C 80×10⁹\u002FL, absolute neutrophil count (ANC) \\\u003C 1.0×10⁹\u002FL.\n  4. Nodal marginal zone lymphoma (NMZL) patients with Ann Arbor stage I - II who have progression\u002Frelapse after local treatment (including surgery, radiotherapy, etc.), or untreated patients with Ann Arbor stage III - IV who meet the GELF criteria recommended by the NCCN guidelines.\n\n  4\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 5. Life expectancy of at least 3 months. 6. The patient has adequate bone marrow (except those caused by MZL), liver and kidney functions.\n\n  7\\. Able to comply with the research procedures and cooperate in the implementation of the entire research process; 8. Written informed consent; 9. Women with fertility agree to take appropriate measures to avoid pregnancy during the treatment period until at least one year after the end of treatment; Men agree to maintain abstinence or use barrier contraception.\n\nExclusion Criteria:\n\n* 1\\. Histologically transformed into high-grade lymphoma. 2. Known central nervous system involvement of MZL. 3. Previous systemic treatment including immunotherapy, chemotherapy or targeted drugs.\n\n  4\\. Previous autologous stem-cell transplantation or allogeneic tissue\u002Fsolid organ transplantation.\n\n  5\\. History of other invasive cancers within the past 3 years that have not received curative treatment or are still receiving anti-cancer treatment (including hormonal therapy for breast or prostate cancer).\n\n  6\\. Complicated with uncontrolled cardiovascular and cerebrovascular diseases (such as New York Heart Association-defined grade 3 or 4 heart failure, arrhythmia, myocardial infarction, stroke, or intracranial hemorrhage), coagulation - disorder diseases, connective tissue diseases, severe infectious diseases (including active pulmonary tuberculosis), etc.\n\n  7\\. Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (positive result shown by polymerase chain reaction \\[PCR\\]). Serological antibody - positive is allowed if HBV DNA \\\u003C 10³ IU\u002Fml; HCV RNA test must be negative.\n\n  8\\. Vaccinated with live attenuated vaccines within 4 weeks before starting investigational treatment. During the study, patients are prohibited from receiving live attenuated vaccine inoculations, including influenza vaccines.\n\n  9\\. Requiring continuous treatment with potent and moderate-effect CYP3A inhibitors or CYP3A inducers.\n\n  10\\. Unable to swallow capsules or having diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction.\n\n  11\\. Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol.\n\n  12\\. Pregnant or lactating women. 13. Other concurrent and uncontrolled medical conditions that, in the investigator's opinion, will affect the patient's participation in the study.",{"count":49,"type":21},145,[24],"Marginal zone lymphoma (MZL) is a common type of indolent lymphoma that originates from the marginal zone of lymphoid follicles. This study aims to evaluate targeted therapy based on the prognostic risk stratification of MZL-IPI in newly diagnosed MZL cases requiring systemic treatment, and provides a basis for precision treatment of MZL.",[27],"RECRUITING","2026-03-19",{"date":56,"type":32},"2026-03-24",{"date":58,"type":32},"2025-01-23",{"date":60,"type":21},"2028-12-31",{"name":62,"class":39},"Ruijin Hospital",3,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":40},"100627414","phase-2-orelabrutinib-combined-with-rituximab--lenalidomide-in-response-adapted-stratified-therapy-for-untreated-mzl-100627414","NCT07448324","Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL","Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL#a Prospective Single Arm Trial","Inclusion Criteria:\n\n1. Aged ≥18 years, either sex.\n2. Histopathologically confirmed CD20-positive marginal zone lymphoma (including MALT, SMZL, and NMZL) with at least 1 measurable lesion.\n3. Stage III or IV disease with an indication for treatment.\n4. No prior systemic therapy. Patients may have received prior local treatment (including surgery, radiotherapy, anti-Helicobacter pylori therapy, or anti-hepatitis C therapy) if they subsequently progressed, relapsed, or were unsuitable for local therapy.\n5. ECOG performance status of 0-2.\n6. Adequate organ function meeting the following criteria:\n\n   1. Blood count: Absolute neutrophil count ≥1.5×10⁹\u002FL, platelets ≥75×10⁹\u002FL, hemoglobin ≥75 g\u002FL. If bone marrow involvement is present: absolute neutrophil count ≥1.0×10⁹\u002FL, platelets ≥50×10⁹\u002FL, hemoglobin ≥50 g\u002FL.\n   2. Blood chemistry: Total bilirubin ≤1.5×ULN, AST or ALT ≤2×ULN; serum creatinine ≤1.5×ULN; serum amylase ≤ULN.\n7. Coagulation: International normalized ratio (INR) ≤1.5×ULN.\n8. Expected survival ≥12 months.\n9. Voluntary provision of written informed consent before trial screening.\n\nExclusion Criteria:\n\n1. Current or history of other malignancies, unless treated with curative intent and without evidence of recurrence or metastasis within the past 5 years.\n2. Central nervous system involvement or transformation to high-grade lymphoma.\n3. Uncontrolled or significant cardiovascular diseases, including:\n\n   1. New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first study drug dose, or arrhythmia requiring treatment at screening; left ventricular ejection fraction (LVEF) \\\u003C50%.\n   2. Primary cardiomyopathy (e.g., dilated, hypertrophic, arrhythmogenic right ventricular, restrictive, or unclassified cardiomyopathy).\n   3. History of clinically significant QTc interval prolongation, or QTc interval \\>470 ms (female) or \\>450 ms (male) at screening.\n   4. Symptomatic coronary artery disease or subjects requiring medication for it.\n   5. Poorly controlled hypertension (defined as failure to achieve target blood pressure after ≥1 month of lifestyle modification combined with an adequate, tolerable regimen of ≥3 antihypertensive drugs including a diuretic, or requiring ≥4 antihypertensive drugs for control).\n4. Active bleeding within 2 months prior to screening, current use of anticoagulants, or any condition deemed by the investigator to indicate a clear bleeding tendency.\n5. History of deep vein thrombosis or pulmonary embolism within the past 6 months.\n6. History of organ transplantation or allogeneic bone marrow transplantation.\n7. Major surgery within 6 weeks or minor surgery within 2 weeks prior to screening. Major surgery requires general anesthesia (diagnostic endoscopy excluded). Insertion of vascular access devices is exempt.\n8. Active infection or uncontrolled HBV (HBsAg positive and\u002For HBcAb positive with positive HBV DNA), HCV Ab positive, HIV\u002FAIDS, or other serious infectious diseases. (Active infection is defined as requiring systemic antimicrobial therapy or associated with systemic signs\u002Fsymptoms of inflammation.)\n9. Current conditions severely impairing pulmonary function, such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or drug-related pneumonia.\n10. Prior treatment with BTK inhibitors, BCR pathway inhibitors (e.g., PI3K, Syk inhibitors), or BCL-2 inhibitors.\n11. Pregnancy, lactation, or unwillingness to use effective contraception in subjects of childbearing potential.\n12. Concomitant use of moderate\u002Fstrong cytochrome P450 CYP3A inhibitors or strong inducers.\n13. Any other condition considered by the investigator to make the subject unsuitable for trial participation.",{"count":72,"type":21},50,[24],"This is a prospective, single-arm, phase II study aimed at evaluating the safety and efficacy of orelabrutinib combined with rituximab ± lenalidomide in response-adapted stratified therapy for untreated marginal zone lymphoma. The primary endpoint is the complete response rate (CRR).",[27],"2026-03-02",{"date":78,"type":32},"2026-03-04",{"date":80,"type":32},"2025-04-01",{"date":82,"type":21},"2030-01-01",{"name":84,"class":39},"The First Affiliated Hospital with Nanjing Medical University",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":108,"locationsCount":63},"100620290","phase-4-application-of-orelabrutinib-with-or-without-cd20-monoclonal-antibody-in-previously-untreated-marginal-zone-lymphoma-100620290","NCT07355699","Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma","Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma:A Phase II, Prospective, Multicenter, Single-Arm Clinical Study","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Pathologically confirmed marginal zone lymphoma;\n* Presence of evaluable lesions;\n* Meets indications for treatment: Fulfills the GELF criteria OR has disease-related clinical symptoms\u002Forgan function impairment;\n* 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:\n\nGastric 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;\n\nNon-gastric MALT and nodal MZL in Ann Arbor non-contiguous stage II or stages III-IV;\n\nSMZL;\n\nGastric MALT classified as Lugano II2, IIE, or IV stage;\n\nPatient intolerance to radiotherapy;\n\nOther MZL patients deemed unsuitable for local radiotherapy by the investigator.\n\n* ECOG score of 0-3;\n* Expected survival time ≥ 3 months;\n* Ability to provide signed informed consent.\n\nExclusion Criteria:\n\n* Currently diagnosed with another malignant tumor;\n* Central nervous system involvement by lymphoma or transformation to a higher grade;\n* Allergy to any of the investigational drugs;\n* Active infection or uncontrolled HBV infection, HIV\u002FAIDS, or other serious infectious diseases;\n* Pregnancy, lactating women, or subjects of childbearing potential unwilling to use contraception;\n* Other situations deemed by the investigator as unsuitable for participation in this trial.",{"count":93,"type":21},88,[95],"PHASE4","This study focuses on treatment-naïve marginal zone lymphoma (MZL) patients and aims to investigate the efficacy and safety of orelabrutinib combined with or without CD20 monoclonal antibody.\n\nThis is a single-arm study without a control group. All subjects will receive orelabrutinib treatment but will be stratified based on disease stage and clinical characteristics into the following two groups:\n\n1. Stage I MZL Patient Group (Monotherapy Group) Treatment regimen: Orelabrutinib monotherapy. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6).\n\n   Target population: Patients with Ann Arbor Stage I gastric MALT MZL, including H. pylori-negative patients or those with unsatisfactory response after anti-H. pylori therapy, as well as other Stage I MZL patients unsuitable for local radiotherapy.\n\n   Sample size: 50 cases.\n2. Stage II-IV MZL Patient Group (Combination Therapy Group) Treatment regimen: Orelabrutinib combined with a CD20 monoclonal antibody. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). CD20 monoclonal antibody (either Rituximab 375mg\u002Fm², intravenous infusion, Day 1 of each cycle, C1-C6; or Obinutuzumab 1000mg, intravenous infusion, on Days 1, 8, and 15 of Cycle 1 \\[C1\\], and on Day 1 of Cycles 2-6 \\[C2-C6\\]).\n\nTarget population: Patients with Ann Arbor Stage II-IV non-gastric MALT MZL, nodal MZL, splenic marginal zone lymphoma (SMZL), and other Stage II-IV MZL patients unsuitable for local radiotherapy.\n\nSample size: 38 cases.",[27],[99,100,101],"Marginal Zone Lymphoma","Orelabrutinib","CD20 Monoclonal Antibody","2026-01-13",{"date":104,"type":32},"2026-01-21",{"date":106,"type":32},"2025-11-25",{"date":60,"type":21},{"name":109,"class":39},"Beijing Tongren Hospital",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":4},"100615955","zanubrutinib-rituximab-and-lenalidomide-in-the-first-line-treatment-of-marginal-zone-lymphoma-100615955","NCT07299331","Zanubrutinib, Rituximab, and Lenalidomide in the First-Line Treatment of Marginal Zone Lymphoma","A Multicenter, Single-Arm, Prospective Clinical Study of Zanubrutinib, Rituximab, and Lenalidomide in the First-Line Treatment of Marginal Zone Lymphoma","Inclusion Criteria:\n\n1. 18-75 years\n2. Histologically confirmed MZL in untreated stage III or IV and needed for therapy as determined by the treating physician\n3. ECOG performance status 0-2\n4. Expected survival ≥ 6 months\n5. Adequate hematologic and organ function: absolute neutrophil count ≥1,000\u002Fmm3 (independent of growth factor support), platelet counts ≥75,000\u002Fmm3, serum aspartate transaminase or alanine transaminase less than 2.5 times the upper limit of normal (ULN), serum creatinine ≤1.5×ULN, and bilirubin ≤1.5×ULN unless bilirubin is due to Gilbert's syndrome, documented liver involvement with lymphoma, or of nonhepatic origin, in which case bilirubin should not exceed 3 g\u002FdL, left ventricular ejection fraction (LVEF) of the heart≥ 50%\n6. Women of childbearing potential and men who were sexually active were required to be practicing a highly effective method of birth control during and after the study\n7. No history of other malignant tumors\n8. At least one measurable lesion with a longest diameter of ≥ 1.5 cm or measurable lesions of extranodal lesions ≥ 1.0 cm.\n9. Able to understand the study and provide signed Informed Consent Form\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Active central nervous system lymphoma\n3. Previous anti-tumor treatment\n4. A severe immediate-type hypersensitivity reaction history for any of the drugs used in this study\n5. History of stroke or intracranial hemorrhage within 6 months before study entry\n6. Received a live attenuated vaccine within 4 weeks prior to enrollment History of human immunodeficiency virus, or active hepatitis C virus, or active hepatitis B virus infection, or any uncontrolled active systemic infection\n7. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification\n8. Other serious medical conditions that might have an impact on this study","75 Years",{"count":72,"type":21},[120],"NA","The goal of this clinical trial is to learn if Zanubrutinib, Rituximab, and Lenalidomide works to treat marginal zone lymphoma as the first-line therapy. It will also learn about the safety of the treatment. The main questions it aims to answer are Does the combined therapy prolong patient survival? What medical problems do participants have when using this therapeutic approach? Researchers will observe the treatment to see if it works well than conventional therapies.\n\nParticipants will Administer drugs as required by the protocol Visit the clinic regularly for checkups and tests Keep a diary of their symptoms, examination and laboratory test indicators",[27],"2025-12-22",{"date":125,"type":32},"2025-12-23",{"date":127,"type":21},"2026-01-01",{"date":129,"type":21},"2031-04-30",{"name":131,"class":39},"Zhengzhou University",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":117,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":40},"100609009","phase-2-orelabrutinib-combined-with-zebetuzumab-and-lenalidomide-for-the-treatment-of-newly-diagnosed-mzl-100609009","NCT07208981","Orelabrutinib Combined With Zebetuzumab and Lenalidomide for the Treatment of Newly Diagnosed MZL","A Prospective Multicenter Study of Orelabrutinib Combined With Zebetuzumab and Lenalidomide or Bendamustine Combined With Rituximab for the Treatment of Newly Diagnosed MZL","Inclusion Criteria:\n\n* 1\\. Age 18-75 years, gender not restricted;\n* 2\\. Histopathologically confirmed CD20-positive marginal zone lymphoma includes MALT, SMZL, and NMZL; at least one measurable lesion;\n* 3\\. Indication for treatment\n\n  * 3.1. Initial diagnosis II 2 or IIE or IV stage gastric MALT treatment indications. Including: ① Meeting the inclusion criteria for clinical trials; ② Presence of lymphoma-related clinical symptoms; ③ Gastrointestinal bleeding (bleeding condition controlled or assessed by the investigator for suitability of inclusion); ④ End-organ damage; ⑤ Large mass; ⑥ Persistent or rapid disease progression; ⑦ Patient's willingness;\n  * 3.2. Recommendations for treatment indications of newly diagnosed stage III-IV non-gastric MALT and NMZL. The GELF criteria, similar to those used for follicular lymphoma, include: ① The presence of ≥3 distinct regions of involved lymph nodes, with each involved lymph node having a diameter of ≥3 cm; ② The presence of any lymph node or extranodal lesion with a diameter \\>7 cm; ③ The presence of B symptoms; ④ Splenomegaly; ⑤ Symptoms of organ compression, pleural or peritoneal effusion; ⑥ Cytopenia caused by the disease; ⑦ Persistent or rapid disease progression, with tumor size increasing by 20%-30% within 2-3 months or approximately 50% within 6 months; ⑧ Meeting the inclusion criteria for clinical trials;\n  * 3.3. Recommended indications for the treatment of newly diagnosed SMZL. Including: ① Progressive or painful splenomegaly; ② Symptomatic or progressive cytopenia such as HB\\\u003C100g\u002FL, PLT\\\u003C80×10\\^9\u002FL, absolute neutrophil count (ANC)\\\u003C1.0×10\\^9\u002FL (note to differentiate from cytopenia caused by autoimmune factors);\n* 4\\. Without prior systemic treatment, may include MZL (marginal zone lymphoma) that has progressed, relapsed, or is unsuitable for local treatment after previous local therapy (local treatment includes surgery, radiotherapy, anti-Helicobacter pylori therapy for at least 12 months, or anti-hepatitis C therapy);\n* 5\\. ECOG performance status score 0-2 points\n* 6\\. The main organ functions meet the following criteria (except for SMZL, which is judged separately by the investigator to meet treatment requirements): Complete blood count: Absolute neutrophil count ≥1.5×10\\^9\u002FL, platelets ≥75×10\\^9\u002FL, hemoglobin ≥75g\u002FL; if accompanied by bone marrow involvement, absolute neutrophil count ≥1.0×10\\^9\u002FL, platelets ≥50×10\\^9\u002FL, hemoglobin ≥50g\u002FL; Blood biochemistry: Total bilirubin ≤ 1.5 times ULN, AST or ALT ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; serum amylase ≤ ULN; creatinine clearance rate ≥ 60 mL\u002Fmin;\n* 7\\. Coagulation function: International Normalized Ratio (INR) ≤1.5 times ULN;\n* 8\\. Expected survival time ≥ 12 months;\n* 9\\. Voluntarily sign a written informed consent before trial screening.\n\nExclusion Criteria:\n\n* 1\\. Currently or previously diagnosed with other malignancies, unless radical treatment has been performed and there is evidence of no recurrence or metastasis within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, and localized squamous cell carcinoma of the skin;\n* 2\\. Lymphoma involving the central nervous system or transforming to a higher grade;\n* 3\\. Uncontrolled or significant cardiovascular diseases, including: a) Occurrence of New York Heart Association (NYHA) Class III-IV congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first administration of the investigational drug, or the presence of treatable arrhythmias at screening, with left ventricular ejection fraction (LVEF) \\\u003C50%; b) Primary cardiomyopathies (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy); c) A clinically significant history of QTc interval prolongation, or QTc interval during the screening period \\>470ms for females and \\>450ms for males; d) Subjects with symptomatic or medication-requiring coronary heart disease; e) Suffering from uncontrolled hypertension (blood pressure remains uncontrolled after more than one month of using a reasonable and tolerable dosage of three or more antihypertensive drugs (including diuretics) based on lifestyle improvements, or blood pressure can only be effectively controlled by taking four or more antihypertensive drugs);\n* 4\\. Active bleeding within 2 months prior to screening, or currently taking anticoagulants, or deemed by the investigator to have a clear bleeding tendency;\n* 5\\. History of deep vein thrombosis or pulmonary embolism in the past six months;\n* 6\\. Underwent major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening. Major surgery refers to procedures performed under general anesthesia, but endoscopic examinations for diagnostic purposes are not considered major surgery. The insertion of vascular access devices is exempt from this exclusion criterion;\n* 7\\. Active infection or uncontrolled HBV (HBsAg positive and\u002For HBcAb positive with HBV DNA titer positive), HCV RNA positive, HIV\u002FAIDS, or other severe infectious diseases;\n* 8\\. Currently, there are subjects with severe pulmonary function impairment due to conditions such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, and drug-related pneumonia: FEV1% or DLCO (or DLCO\u002FVA) %pred \\\u003C 40% (with severe pulmonary ventilation and gas exchange dysfunction);\n* 9\\. Pregnant, lactating women and childbearing age subjects unwilling to use contraception;\n* 10\\. Need to continuously take medications with moderate to strong inhibitory or strong inducing effects on cytochrome P450 CYP3A;\n* 11\\. The investigator considers other conditions unsuitable for participating in this trial.",{"count":140,"type":21},169,[24],"This is an open-label, multicenter, phase 2, non-randomized study aiming to evaluate the efficacy and safety of orelabrutinib combined with zebetuzumab and lenalidomide or bendamustine combined with rituximab in the treatment of newly diagnosed marginal zone lymphoma (MZL).",[27],"2025-09-29",{"date":146,"type":32},"2025-10-06",{"date":148,"type":32},"2025-08-14",{"date":150,"type":21},"2031-06-01",{"name":84,"class":39},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":40},"100569942","phase-2-orelabrutinib-combined-with-rituximab-versus-r-cvp-in-the-untreated-mzl-a-randomized-open-phase-ii-trial-100569942","NCT06700798","Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II Trial","A Randomized, Open-Label Phase II Clinical Study of Orelabrutinib Combined With Rituximab Versus R-CVP in the Treatment of Newly Diagnosed Marginal Zone Lymphoma (MZL).","Inclusion Criteria:\n\n1.Age ≥18 years； 2.ECOG performance status level 0\\~2； 3.Life expectancy of at least 12 weeks; 4.Confirmed CD20-positive marginal zone lymphoma according to the WHO 2008 lymphoma classification criteria, including splenic MZL, nodal MZL, and extranodal MZL subtypes; 5.Measurable lesions detected by enhanced computed tomography (CT) or magnetic resonance imaging (MRI); 6.Indication for treatment according to NCCN guidelines and no prior systemic treatment for MZL; 7.Normal function of major organs; 8.Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and must be willing to use appropriate contraceptive methods during the trial period and for 8 weeks after the last administration of the trial medication. For men, they must agree to use appropriate contraceptive methods during the trial period and for 8 weeks after the last administration of the trial medication or have undergone surgical sterilization; 9.The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with follow-up.\n\n\\-\n\nExclusion Criteria:\n\n1. Patients with central nervous system involvement;\n2. History or concurrent other untreated malignant tumors, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and superficial bladder cancer;\n3. Patients with the following cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval for males ≥450 ms, for females ≥470 ms); Class III to IV heart failure according to NYHA standards, or echocardiography indicating left ventricular ejection fraction (LVEF) \\\u003C50%;\n4. Coagulation abnormalities (INR \\>1.5 or prothrombin time (PT) \\>ULN+4 seconds or APTT \\>1.5 ULN), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy;\n5. Arterial\u002Fvenous thrombotic events within 12 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n6. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.);\n7. Major surgical procedures or severe traumatic injuries, fractures, or ulcers within 4 weeks prior to enrollment;\n8. Factors that significantly affect the absorption of oral medications, such as inability to swallow, chronic diarrhea, and intestinal obstruction;\n9. Active infections requiring antimicrobial treatment (e.g., requiring antibacterial, antiviral drugs, excluding chronic hepatitis B antiviral treatment, antifungal treatment);\n10. Active hepatitis B (HBV DNA ≥2000 IU\u002FmL or 104 copies\u002FmL) or hepatitis C (hepatitis C antibody positive, and HCV RNA above the lower limit of detection of the analytical method);\n11. History of substance abuse and inability to quit or mental disorders;\n12. Participation in other anticancer drug clinical trials within 4 weeks prior to enrollment;\n13. Received treatment with potent CYP3A4 inhibitors within 7 days prior to enrollment, or received treatment with potent CYP3A4 inducers within 12 days prior to study participation;\n14. Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to use effective contraceptive measures;\n15. Other situations judged by the investigator that may affect the conduct of the clinical study and the determination of study results.",{"count":160,"type":21},90,[24],"This study is a randomized, open-label, multicenter, prospective clinical trial aimed at evaluating the efficacy and safety of orelabrutinib combined with rituximab for the previously untreat MZL",[27],[165],"Orelabrutinib combined with Rituximab versus R-CVP","2025-06-14",{"date":168,"type":32},"2025-06-17",{"date":170,"type":32},"2024-12-01",{"date":172,"type":21},"2027-12-04",{"name":174,"class":39},"Fei Li",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100594651","phase-2-orelabrutinib-combined-with-rituximab-as-first-line-systemic-treatment-for-marginal-zone-lymphoma-100594651","NCT07022223","Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma","A Single-arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma","Inclusion Criteria:\n\n* Age ≥ 18 years, regardless of gender;\n* Histologically confirmed CD20-positive marginal zone lymphoma, including MALT, SMZL, and NMZL, with at least one lesion outside the spleen measuring more than 1.5 cm in any axis;\n* MZL that has progressed or relapsed after prior local therapy (including surgery, radiotherapy, anti-Helicobacter pylori treatment, and anti-hepatitis C treatment), or is not suitable for local therapy;\n* ECOG performance status of 0-2;\n* Presence of an indication for treatment as judged by the investigator (symptomatic, cytopenia, risk of end-organ damage, bulky disease, ongoing progression, or patient's desire for treatment);\n* Adequate function of major organs, as follows:\n* Hematology: Absolute neutrophil count ≥ 1.5×109\u002FL, platelets ≥ 75×109\u002FL, hemoglobin ≥ 75 g\u002FL; if there is bone marrow involvement, absolute neutrophil count ≥ 1.0×109\u002FL, platelets ≥ 50×109\u002FL, hemoglobin ≥ 50 g\u002FL;\n* Biochemistry: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST or ALT ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; serum amylase ≤ ULN;\n* Coagulation: International normalized ratio (INR) ≤ 1.5 times ULN.\n* Life expectancy of ≥ 3 months;\n* Voluntary written informed consent obtained before screening for the trial.\n\nExclusion Criteria:\n\n* Currently or previously having other malignancies, unless there is evidence of no recurrence or metastasis within the past 5 years after curative treatment;\n* Lymphoma involvement of the central nervous system or transformation to high-grade lymphoma;\n* Non-hematological toxicities from prior anti-cancer treatments not recovered to ≤ Grade 1 (excluding alopecia);\n* Presence of uncontrolled or significant cardiovascular disease, including:\n* New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months before the first administration of the study drug, or arrhythmias requiring treatment at screening, left ventricular ejection fraction (LVEF) \\\u003C 50%;\n* Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);\n* History of clinically significant QTc interval prolongation, or QTc interval \\> 470 ms for females, \\> 450 ms for males during the screening period;\n* Symptomatic or medically treated coronary artery disease;\n* Uncontrolled hypertension (defined as blood pressure not reaching target levels despite a reasonable and tolerable full dose of three or more antihypertensive drugs (including diuretics) for more than one month, or requiring four or more antihypertensive drugs to effectively control blood pressure).\n* Active bleeding within 2 months before screening, or currently taking anticoagulant drugs, or deemed by the investigator to have a clear tendency to bleed;\n* Urine protein ≥ 2+, and 24-hour urine protein quantification ≥ 2 g\u002F24 hours;\n* History of deep vein thrombosis or pulmonary embolism within the past six months;\n* History of organ transplantation or allogeneic bone marrow transplantation;\n* Major surgery within 6 weeks before screening or minor surgery within 2 weeks before screening. Major surgery is defined as surgery using general anesthesia, but diagnostic endoscopy is not considered major surgery. Insertion of a vascular access device will be exempt from this exclusion criterion;\n* Active infection or uncontrolled HBV (HBsAg positive and\u002For HBcAb positive with positive HBV DNA titer), HCV Ab positive, HIV\u002FAIDS, or other severe infectious diseases;\n* Currently having pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or other conditions that significantly affect pulmonary function;\n* Previous treatment with BTK, BCR pathway inhibitors (such as PI3K, Syk), or BCL-2 inhibitors;\n* Suitable and preparing for stem cell transplantation;\n* Any psychiatric or cognitive impairment that may limit their understanding, execution of the informed consent form, and compliance with the study;\n* Subjects with drug abuse or alcoholism;\n* Pregnant, breastfeeding women, and fertile subjects unwilling to use contraception;\n* Need to continuously take drugs with moderate to severe inhibitory or strong inducing effects on cytochrome P450 CYP3A;\n* Any other condition deemed by the investigator as unsuitable for participation in this trial.",{"count":183,"type":21},51,[24],"This is a single-arm, prospective clinical study to evaluate the efficacy and safety of orelabrutinib combined with rituximab as first-line systemic treatment for marginal zone lymphoma.",[27],"2025-06-08",{"date":189,"type":32},"2025-06-15",{"date":191,"type":32},"2025-03-11",{"date":193,"type":21},"2029-09-11",{"name":195,"class":39},"Second Affiliated Hospital, School of Medicine, Zhejiang University",18,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100579412","study-to-assess-effectiveness-and-safety-of-zanubrutinib-for-patients-with-marginal-zone-lymphoma-treated-in-italy-under-the-named-patient-program-npp-100579412","NCT06823960","Study to Assess Effectiveness and Safety of Zanubrutinib for Patients With Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP)","An Italian Multicenter Retrospective Observational Study to Assess Effectiveness and Safety of Zanubrutinib for Patients With Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP)","ZanOs","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of relapsed\u002Frefractory marginal zone lymphoma\n2. Patients who received at least one dose of zanubrutinib under the Named patient program (D.M. 7 Sep 2017), between January 2021 and October 2023 3) Age≥18 at start of zanubrutinib therapy. 4) Signature of written informed consent to study participation and personal data processing.\n\nExclusion Criteria:\n\n1\\) relapsed\u002Frefractory marginal zone lymphoma patients who received zanubrutinib in a clinical trial context.",{"count":206,"type":21},59,"OBSERVATIONAL","Observational, non-interventional, retrospective, multicentre study focusing on efficacy and safety of zanubrutinib in daily clinical practice in patients with relapsed\u002Frefractory (R\u002FR) marginal zone lymphoma.",[27],[211],"zanubrutinib","2025-02-11",{"date":214,"type":32},"2025-02-12",{"date":216,"type":32},"2024-12-09",{"date":218,"type":21},"2025-06",{"name":220,"class":39},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",15]