[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548916":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":25,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":25,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":25,"enrollmentInfo":46,"targetDuration":25,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":58,"whyStopped":25,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":25},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Elder Patients（≥65）","EXPERIMENTAL","Induction: Zanubrutinib and Obinutuzumab 1year\n\nMaintenance: Zanubrutinib continued until progression",[13],"Drug: Zanubrutinib,Obinutuzumab",{"label":15,"type":10,"description":16,"interventionNames":17},"Young Patients with High risk （≥18，\u003C65）","Induction: Zanubrutinib and R-BAC 6 cycles\n\nConsolidation: ASCT（If eligible for transplantation），Otherwise, the patient was directly entered into maintenance treatment\n\nMaintenance: Zanubrutinib continued until progression",[18],"Drug: Zanubrutinib and R-BAC",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Zanubrutinib,Obinutuzumab","Zanubrutinib, 160mg PO BID. C1D17 continuously for 1 year or until progressive disease； Obinutuzumab ：Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and 15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks，up to 20 doses. 1 cycle = 28 days.\n\nMaintenance: Zanubrutinib, 160mg PO BID",[9],null,{"type":21,"name":27,"description":16,"armGroupLabels":28,"otherNames":25},"Zanubrutinib and R-BAC",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"keshu Zhou","CONTACT","0371-65587306","drzhouks77@163.com",{"type":36,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100548916","phase-2-this-is-a-phase-ii-open-label-multicentre-study-of-zanubrutinib-containing-regimens-in-patients-with-newly-diagnosed-mantle-cell-lymphoma-100548916",false,"NCT06427213","This is a Phase II, Open-label, Multicentre Study of Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma","A Study of the Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma","Inclusion Criteria:\n\n1. Voluntary participation in clinical study; Fully understand and understand the study and sign the informed consent form (ICF);Willingness to follow and ability to complete all study steps\n2. Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)，previous untreatment for mantle-cell lymphoma (MCL)\n3. The elderly group ≥65 years old;The young group was ≥18 years old and \\\u003C 65 years old.\n4. ECOG Performance Status 0-3\n5. Life expectancy of at least 3 months\n6. At least one evaluable lesion according to 2014 Lugano criteria;\n7. Proper functioning of the major organs, no major heart, lung, liver, kidney, or immunodeficiency (no blood transfusion, granulocyte colony-stimulating factor, or other medical support within 7 days before starting the study) :Hemoglobin (HB)≥60 g\u002FL;Absolute neutrophil count(ANC)≥0.5×10\\^9\u002FL;Platelet count（PLT）≥50×10\\^9\u002FL;AST and ALT ≤ 2.5 x ULN；Total bilirubin ≤ 1.5 times the ULN;Ccr≥40ml\u002Fmin（Cockcroft-Gault ）；Left Ventricular Ejection Fraction (LVEF) ≥ 50%\n\nExclusion Criteria:\n\n1. The presence of other tumors could affect the study medication or interfere with the results;\n2. Patients require treatment with strong or moderate CYP3A inhibitors;\n3. Pregnant or lactating women;\n4. Known to be allergic to the test drug ingredients;\n5. Subjects of childbearing potential who are unwilling to use highly effective contraceptive methods;\n6. Live vaccination was administered within 28 days prior to treatment\n7. Known human immunodeficiency virus (HIV) infection or suggested active B or C infection The following serologic status of hepatitis C virus infection: 1) Hepatitis B virus (HBV) DNA positive. Positive hepatitis B surface antigen (HBsAg) or anti-hepatitis B core antibody (HBcAb) seropositive if HBV DNA is undetectable and willing to accept Monthly surveillance for HBV reactivation was eligible. 2) Hepatitis C virus (HCV) antibody positive. For patients with HCV antibodies present, if undetectable HCV RNA, can be included;\n8. Severe coagulopathy and serious impairment of heart, brain, lung, liver, kidney and other organs\n9. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;\n10. Any risk that is considered by the investigator to be likely to affect the safety of the subjects or to pose a risk to the study And vital diseases, medical conditions, or organ system insufficiency.","ALL","18 Years",{"count":47,"type":48},41,"ESTIMATED","INTERVENTIONAL",[51],"PHASE2","This is a phase II, open-label, multicentre study of Zanubrutinib-containing regimens in patients with newly diagnosed mantle cell lymphoma.",[54,55],"Lymphoma, Mantle-Cell","Lymphoma, Non-Hodgkin",[57],"Zanubrutinib","NOT_YET_RECRUITING","2024-05-19",{"date":61,"type":62},"2024-05-23","ACTUAL",{"date":64,"type":48},"2024-05-20",{"date":66,"type":48},"2029-12-30",{"name":5,"class":6}]