[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569942":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":32,"studyPopulation":25,"armGroups":33,"interventions":49,"overallOfficials":73,"centralContacts":77,"locations":83,"responsibleParty":101,"collaborators":25,"id":105,"slug":25,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":25,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":25,"enrollmentInfo":113,"targetDuration":25,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":85,"whyStopped":25,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"The First Affiliated Hospital of Nanchang University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"CRR","The proportion of patients who achieve Complete Remission (CR) at the end of the combined antitumor treatment","up to two years",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"ORR","ORR is defined as the percentage of participants with partial or complete response",{"measure":18,"description":19,"timeFrame":20},"PFS rate at 24month","the proportion of patients who have not experienced disease progression or death due to any cause within 2 years of receiving the first dose of the study medication.","Two years after the last patient was enrolled.",{"measure":22,"description":23,"timeFrame":24},"Safety parameters","Type, frequency, and severity of AEs","up to 3 years",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE","For patients with advanced-stage MZL who require treatment, immunochemotherapy is the standard therapy, including regimens such as BR, R-CHOP, R-CVP, etc. The second-generation BTK inhibitor, orelabrutinib, has shown promising efficacy in relapsed\u002Frefractory MZL, suggesting that a chemofree regimen combining orelabrutinib with rituximab could also achieve good clinical outcomes in first-line treatment of MZL. However, there is still a lack of prospective studies to confirm this. This study plans to compare the efficacy and safety of orelabrutinib combined with rituximab followed by maintenance therapy with orelabrutinib to the R-CVP regimen.",[34,41],{"label":35,"type":36,"description":37,"interventionNames":38},"OR-R","EXPERIMENTAL","Orelabrutinib 150mg, oral, once daily, Days 1-28, with a cycle of 4 weeks; Cycles 1-24； Rituximab: 375mg\u002Fm\\^2, intravenous, Day 1, with a cycle of 4 weeks; Cycles 1-6",[39,40],"Drug: Orelabrutinib","Drug: rituximab",{"label":42,"type":43,"description":44,"interventionNames":45},"R-CVP","ACTIVE_COMPARATOR","Rituximab: 375mg\u002Fm\\^2, intravenous, Day 1, with a cycle of 3 weeks; Cycles 1-8； Cyclophosphamide: 750mg\u002Fm\\^2, intravenous, Day 1, with a cycle of 3 weeks;Cycles 1-8； Vincristine: 1.4mg\u002Fm\\^2 (maximum 2mg), intravenous, Day 1, with a cycle of 3 weeks;Cycles 1-8； Prednisone: 60mg\u002Fm\\^2, oral, Days 1-5, with a cycle of 3 weeks，Cycles 1-8\n\nSubsequently, maintenance with rituximab monotherapy until two years from the start of treatment or until toxicity intolerable.",[40,46,47,48],"Drug: Cyclophosphamide","Drug: Vincristine","Drug: Prednisone tablet",[50,57,61,65,69],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"DRUG","Orelabrutinib","150mg po",[35],[56],"ICP-022",{"type":51,"name":58,"description":59,"armGroupLabels":60,"otherNames":25},"rituximab","375mg\u002Fm\\^2, intravenous",[35,42],{"type":51,"name":62,"description":63,"armGroupLabels":64,"otherNames":25},"Cyclophosphamide","750mg\u002Fm\\^2",[42],{"type":51,"name":66,"description":67,"armGroupLabels":68,"otherNames":25},"Vincristine","1.4mg\u002Fm\\^2",[42],{"type":51,"name":70,"description":71,"armGroupLabels":72,"otherNames":25},"Prednisone tablet","60mg\u002Fm\\^2",[42],[74],{"name":75,"affiliation":5,"role":76},"Fei Li, professor","PRINCIPAL_INVESTIGATOR",[78],{"name":79,"role":80,"phone":81,"phoneExt":25,"email":82},"Yulan Zhou Doctor, PhD","CONTACT","86-0791-88692743","wenxin_yl@163.com",[84],{"facility":5,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"RECRUITING","Nanchang","Jiangxi","330000","China","CN",{"type":92,"coordinates":93},"Point",[94,95],115.85306,28.68396,{"lat":95,"lon":94},[98],{"name":99,"role":80,"phone":100,"phoneExt":25,"email":82},"Yulan Zhou doctor, PhD","86-0791-88692748",{"type":102,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Fei Li","Chief physician","100569942",false,"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.","ALL","18 Years",{"count":114,"type":115},90,"ESTIMATED","INTERVENTIONAL",[118],"PHASE2","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",[121],"Marginal Zone Lymphoma(MZL)",[123],"Orelabrutinib combined with Rituximab versus R-CVP","2025-06-14",{"date":126,"type":127},"2025-06-17","ACTUAL",{"date":129,"type":127},"2024-12-01",{"date":131,"type":115},"2027-12-04",{"name":103,"class":6},1]