[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608264":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":57,"collaborators":59,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":34,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":34,"enrollmentInfo":81,"targetDuration":34,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":34,"overallStatus":46,"whyStopped":34,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Orelabrutinib + Rituximab +\u002F- ASCT and Orelabrutinib Maintenance","EXPERIMENTAL","1. In induction phase, patients will receive rituximab 375 mg\u002Fm² IV on day 1,8,15,22 in Cycle 1, then day 1\u002Fcycle, and orelabrutinib 150 mg\u002Fday PO once daily, every 28 day per cycle for 6 cycles. Patients with an objective response (complete or partial) after induction therapy, who meet ASCT eligibility criteria and consent, proceed to transplantation.\n2. ASCT: BEAM pretreatment. Patients receive carmustine on day -7, etoposide on days -6-(-3), cytarabine on days -6-(-3) and melphalan on day -2.\n3. In maintenance phase, patients will recieve orelabrutinib 150 mg\u002Fday PO once daily until disease progression or intolerable toxicity.",[13,14,15,16],"Drug: Orelabrutinib","Drug: Rituximab (R)","Drug: BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan)","Drug: orelabrutinib maintenance",[18,25,30,35],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Orelabrutinib","orelabrutinib 150mg\u002Fday PO once daily",[9],[24],"Induction phase",{"type":19,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Rituximab (R)","rituximab 375 mg\u002Fm² IV on day 1, 8, 15, 22 in Cycle 1, then day 1\u002Fcycle",[9],[24],{"type":19,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan)","the reference doses are as follows (each center may adjust them as appropriate based on actual conditions): carmustine 300mg\u002Fm² IV d-1; etoposide 200mg\u002Fm² IV d-6-(-3); cytarabine 200mg\u002Fm² IV d-6-(-3); melphalan 140mg\u002Fm² IV d-2.",[9],null,{"type":19,"name":36,"description":21,"armGroupLabels":37,"otherNames":34},"orelabrutinib maintenance",[9],[39],{"name":40,"role":41,"phone":42,"phoneExt":34,"email":43},"Li Wang","CONTACT","+862164370045 ext 610707","wl11194@rjh.com.cn",[45],{"facility":5,"status":46,"city":47,"state":34,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":34},"RECRUITING","Shanghai","200025","China","CN",{"type":52,"coordinates":53},"Point",[54,55],121.45806,31.22222,{"lat":55,"lon":54},{"type":58,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[60,62,64,66,68,70],{"name":61,"class":6},"Fujian Medical University Union Hospital",{"name":63,"class":6},"The First Affiliated Hospital of Anhui Medical University",{"name":65,"class":6},"The Third Xiangya Hospital of Central South University",{"name":67,"class":6},"First Affiliated Hospital of Wenzhou Medical University",{"name":69,"class":6},"Qilu Hospital of Shandong University",{"name":71,"class":6},"Huadong Hospital","100608264","phase-2-orelabrutinib-and-rituximab-with-optional-autologous-hematopoietic-stem-cell-transplantation-in-mcl-treatment-100608264",false,"NCT07199296","Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment","A Prospective, Multicenter, Open-Label Clinical Study of Orelabrutinib in Combination With Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in Treatment-Naive, Non-High-Risk Mantle Cell Lymphoma (MCL)","Inclusion Criteria:\n\n* Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.\n* Age \\> 14 years of age, both genders are eligible.\n* Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible.\n* At least one measurable lesion.\n* Laboratory tests (blood routine, liver and kidney function) meet the following requirements: a) Blood routine: White blood cell count ≥3.0×10\\^9\u002FL, absolute neutrophil count ≥1.5×10\\^9\u002FL, hemoglobin ≥90g\u002FL, platelet count ≥75×10\\^9\u002FL. b) Liver function: Transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal. c) Serum creatinine 44-133 mmol\u002FL.\n* The investigator judges that the subject's life expectancy is greater than 12 weeks from the time of screening.\n* Willing and able to participate in all required assessments and procedures of the study protocol.\n\nExclusion Criteria:\n\n* Patients who have previously received treatment with BTK inhibitors.\n* Any one of the following high-risk factors is present: MIPI score of 6-11, Ki67 \\> 30%, TP53 abnormality, blastic or pleomorphic variation.\n* Patients with severe complications or serious infections.\n* Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.\n* Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections.\n* HIV-infected individuals.\n* Patients with mental disorders or those who are known or suspected to be unable to fully comply with the study protocol.\n* Patients whom the investigator judges to have other conditions that make them unsuitable for participation in this study.","ALL","14 Years",{"count":82,"type":83},45,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib in combination with rituximab with optional autologous hematopoietic stem cell transplantation in patients with non-high-risk mantle cell lymphoma (MCL). The primary objective is to assess the optimal complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.",[89],"Mantle Cell Lymphoma (MCL)","2025-09-28",{"date":92,"type":93},"2025-09-30","ACTUAL",{"date":95,"type":93},"2025-07-01",{"date":97,"type":83},"2028-07-01",{"name":5,"class":6},1]