[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569942":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":48,"centralContacts":52,"locations":58,"responsibleParty":76,"collaborators":35,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":35,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":35,"enrollmentInfo":89,"targetDuration":35,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":60,"whyStopped":35,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"The First Affiliated Hospital of Nanchang University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13,14],"Drug: Orelabrutinib","Drug: rituximab",{"label":16,"type":17,"description":18,"interventionNames":19},"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.",[14,20,21,22],"Drug: Cyclophosphamide","Drug: Vincristine","Drug: Prednisone tablet",[24,31,36,40,44],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Orelabrutinib","150mg po",[9],[30],"ICP-022",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"rituximab","375mg\u002Fm\\^2, intravenous",[9,16],null,{"type":25,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Cyclophosphamide","750mg\u002Fm\\^2",[16],{"type":25,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Vincristine","1.4mg\u002Fm\\^2",[16],{"type":25,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"Prednisone tablet","60mg\u002Fm\\^2",[16],[49],{"name":50,"affiliation":5,"role":51},"Fei Li, professor","PRINCIPAL_INVESTIGATOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":35,"email":57},"Yulan Zhou Doctor, PhD","CONTACT","86-0791-88692743","wenxin_yl@163.com",[59],{"facility":5,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"RECRUITING","Nanchang","Jiangxi","330000","China","CN",{"type":67,"coordinates":68},"Point",[69,70],115.85306,28.68396,{"lat":70,"lon":69},[73],{"name":74,"role":55,"phone":75,"phoneExt":35,"email":57},"Yulan Zhou doctor, PhD","86-0791-88692748",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"SPONSOR_INVESTIGATOR","Fei Li","Chief physician","100569942","phase-2-orelabrutinib-combined-with-rituximab-versus-r-cvp-in-the-untreated-mzl-a-randomized-open-phase-ii-trial-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":90,"type":91},90,"ESTIMATED","INTERVENTIONAL",[94],"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",[97],"Marginal Zone Lymphoma(MZL)",[99],"Orelabrutinib combined with Rituximab versus R-CVP","2025-06-14",{"date":102,"type":103},"2025-06-17","ACTUAL",{"date":105,"type":103},"2024-12-01",{"date":107,"type":91},"2027-12-04",{"name":78,"class":6},1]