[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526562":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":11,"centralContacts":11,"locations":30,"responsibleParty":51,"collaborators":11,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":11,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":11,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ZBR","EXPERIMENTAL",null,[13,14,15],"Drug: Zanubrutinib","Drug: Rituximab","Drug: Bendamustin",[17,22,26],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"DRUG","Zanubrutinib","160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 2 years of follow-up",[9],{"type":18,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"Rituximab","375 mg\u002Fm\\^2 ivgtt, D0 of each 28-day cycle",[9],{"type":18,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Bendamustin","90mg\u002Fm\\^2 ivgtt, D0 of each 28-day cycle",[9],[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Shanghai","Shanghai Municipality","200020","China","CN",{"type":39,"coordinates":40},"Point",[41,42],121.45806,31.22222,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Weili ZHAO","CONTACT","+862164370045","610707","zwl_trial@163.com",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Zhao Weili","Professor","100526562","phase-2-a-study-of-the-zanubrutinib-given-in-combination-with-bendamustine-and-rituximab-in-elderly-or-tp53-alterations-or-chemotherapy-intolerance-patients-with-newly-diagnosed-mantle-cell-lymphoma-100526562",false,"NCT06136351","A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma","Inclusion Criteria:\n\n* 18 years\n\n  * Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)\n  * FISH with del(17p)\u002FTP53 mutation or ≥65 years; or\\\u003C65 years but chemotherapy intolerance;\n  * Life expectancy of \\> 3 months (in the opinion of the investigator);\n  * Creatinine Clearance Rate (CCR) ≥ 50 mL\u002Fmin or estimated Glomerular Filtration ●Rate (eGFR) ≥ 60 mL\u002F(min·1.73 m\\^2);\n  * International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 times the upper limit of normal;\n  * Left Ventricular Ejection Fraction (LVEF) ≥ 50%;\n  * Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative.\n\nExclusion Criteria:\n\n* Pregnant or lactating women;\n* Known Hepatitis B Virus (HBV) and\u002For Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \\> detectable limit);\n* With acquired or congenital immunodeficiency;\n* With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF \\\u003C 50%;\n* Known to be allergic to the test drug ingredients;\n* Diagnosed with or being treated for malignancy other than lymphoma;\n* With severe infection;\n* Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results;\n* Deemed unsuitable for the group.","ALL","18 Years",{"count":64,"type":65},23,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib given in combination with bendamustine and rituximab in (elderly or TP53 alterations or chemotherapy intolerance) patients with newly diagnosed mantle cell lymphoma.",[71],"Lymphoma, Mantle-Cell","2023-11-24",{"date":74,"type":75},"2023-11-29","ACTUAL",{"date":77,"type":75},"2023-11-15",{"date":79,"type":65},"2027-11-01",{"name":5,"class":6},1]