[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594651":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":19,"locations":25,"responsibleParty":249,"collaborators":251,"id":280,"slug":281,"hasResults":282,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":18,"eligibilityCriteria":286,"healthyVolunteers":282,"sex":287,"minAge":288,"maxAge":18,"enrollmentInfo":289,"targetDuration":18,"studyType":292,"phases":293,"briefSummary":295,"conditions":296,"keywords":18,"overallStatus":27,"whyStopped":18,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":307},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"orelabrutinib combined with rituximab regimen","EXPERIMENTAL","All participants will receive induction therapy with the orelabrutinib and rituximab regimen. The treatment cycle is 28 days, with a total of 6 cycles. The induction treatment period is as follows:\n\nCycle 1: Rituximab, 375 mg\u002Fm², on Day 1. Cycles 2-6:Orelabrutinib, 150 mg, once daily orally, from Day 1 to Day 28. Rituximab, 375 mg\u002Fm², on Day 1.\n\nPatients who achieve a partial response (PR) or better will enter a 2-year maintenance period with orelabrutinib.",[13],"Drug: orelabrutinib combined with rituximab regimen",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],null,[20],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"yun Liang","CONTACT","13957136178","liangyun@zju.edu.cn",[26,46,59,69,79,92,105,115,128,141,154,167,177,190,200,210,223,236],{"facility":5,"status":27,"city":28,"state":29,"zip":18,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"RECRUITING","Hangzhou","Zhejiang","China","CN",{"type":33,"coordinates":34},"Point",[35,36],120.16142,30.29365,{"lat":36,"lon":35},[39,41,43],{"name":21,"role":22,"phone":40,"phoneExt":18,"email":24},"+86 13957136178",{"name":21,"role":42,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"name":44,"role":45,"phone":18,"phoneExt":18,"email":18},"xian Li","SUB_INVESTIGATOR",{"facility":47,"status":27,"city":48,"state":18,"zip":18,"country":30,"countryCode":31,"cosmosGeoPoint":49,"geoPoint":53,"contacts":54},"Dongyang People's Hospital","Dongyang",{"type":33,"coordinates":50},[51,52],120.22528,29.26778,{"lat":52,"lon":51},[55],{"name":56,"role":22,"phone":57,"phoneExt":18,"email":58},"gongqiang Wu","+86 13757950788","13757950788@163.com",{"facility":60,"status":27,"city":28,"state":18,"zip":18,"country":30,"countryCode":31,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"Affiliated Hangzhou First People's Hospital",{"type":33,"coordinates":62},[35,36],{"lat":36,"lon":35},[65],{"name":66,"role":22,"phone":67,"phoneExt":18,"email":68},"yaping Xie","+86 139 5804 4620","xieyapingzj@163.com",{"facility":70,"status":27,"city":28,"state":18,"zip":18,"country":30,"countryCode":31,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"Zhejiang cancer 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University","Ningbo",{"type":33,"coordinates":132},[133,134],121.54945,29.87819,{"lat":134,"lon":133},[137],{"name":138,"role":22,"phone":139,"phoneExt":18,"email":140},"ying Lu","+86 13586090834","814871416@qq.com",{"facility":142,"status":27,"city":143,"state":18,"zip":18,"country":30,"countryCode":31,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Quzhou People's Hospital","Quzhou",{"type":33,"coordinates":145},[146,147],118.86861,28.95944,{"lat":147,"lon":146},[150],{"name":151,"role":22,"phone":152,"phoneExt":18,"email":153},"wenping Wu","+86 15657009869","2545095140@qq.com",{"facility":155,"status":27,"city":156,"state":18,"zip":18,"country":30,"countryCode":31,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Shaoxing Central Hospital","Shaoxing",{"type":33,"coordinates":158},[159,160],120.57864,30.00237,{"lat":160,"lon":159},[163],{"name":164,"role":22,"phone":165,"phoneExt":18,"email":166},"jianzhi Zhao","+86 15067570789","zhao_jianzhi@163.com",{"facility":168,"status":27,"city":156,"state":18,"zip":18,"country":30,"countryCode":31,"cosmosGeoPoint":169,"geoPoint":171,"contacts":172},"shaoxing People's Hospital",{"type":33,"coordinates":170},[159,160],{"lat":160,"lon":159},[173],{"name":174,"role":22,"phone":175,"phoneExt":18,"email":176},"jiaping Fu","+86 13867529690","fujiaping1@sina.com",{"facility":178,"status":27,"city":179,"state":18,"zip":18,"country":30,"countryCode":31,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Taizhou Central Hospital","Taizhou",{"type":33,"coordinates":181},[182,183],119.90812,32.49069,{"lat":183,"lon":182},[186],{"name":187,"role":22,"phone":188,"phoneExt":18,"email":189},"linglong Xu","+86 18857628662","xull@tzc.edu.cn",{"facility":191,"status":27,"city":179,"state":18,"zip":18,"country":30,"countryCode":31,"cosmosGeoPoint":192,"geoPoint":194,"contacts":195},"Taizhou First People's 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13705883857","wzly1974@hotmail.com",{"facility":224,"status":27,"city":225,"state":18,"zip":18,"country":30,"countryCode":31,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Yuyao People's Hospital","Yuyao",{"type":33,"coordinates":227},[228,229],121.14944,30.05,{"lat":229,"lon":228},[232],{"name":233,"role":22,"phone":234,"phoneExt":18,"email":235},"yongming Xia","+86 19957408686","xymflI@163.com",{"facility":237,"status":27,"city":238,"state":18,"zip":18,"country":30,"countryCode":31,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"Affiliated Zhuji Hospital ofWenzhou Medical University","Zhuji",{"type":33,"coordinates":240},[241,242],120.24233,29.71877,{"lat":242,"lon":241},[245],{"name":246,"role":22,"phone":247,"phoneExt":18,"email":248},"mei Zhou","+86 13967550366","104397707@qq.com",{"type":250,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[252,253,254,255,257,258,259,261,262,263,265,267,269,271,274,276,278],{"name":106,"class":6},{"name":191,"class":6},{"name":80,"class":6},{"name":256,"class":6},"Zhejiang Cancer Hospital",{"name":47,"class":6},{"name":224,"class":6},{"name":260,"class":6},"Taizhou Hospital",{"name":155,"class":6},{"name":93,"class":6},{"name":264,"class":6},"Shaoxing People's Hospital",{"name":266,"class":6},"Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University",{"name":268,"class":6},"The Central Hospital of Lishui City",{"name":270,"class":6},"Second Affiliated Hospital of Wenzhou Medical University",{"name":272,"class":273},"Ningbo People's Hospital","UNKNOWN",{"name":275,"class":6},"The People's Hospital of Quzhou",{"name":277,"class":6},"Zhejiang University",{"name":279,"class":6},"Zhuji People's Hospital of Zhejiang Province","100594651","phase-2-orelabrutinib-combined-with-rituximab-as-first-line-systemic-treatment-for-marginal-zone-lymphoma-100594651",false,"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.","ALL","18 Years",{"count":290,"type":291},51,"ESTIMATED","INTERVENTIONAL",[294],"PHASE2","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.",[297],"Marginal Zone Lymphoma(MZL)","2025-06-08",{"date":300,"type":301},"2025-06-15","ACTUAL",{"date":303,"type":301},"2025-03-11",{"date":305,"type":291},"2029-09-11",{"name":5,"class":6},18]