[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562910":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":44,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Zhengzhou University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"axi-cel treatment","EXPERIMENTAL",null,[13],"Biological: Axicabtagene Ciloleucel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","Axicabtagene Ciloleucel","Axicabtagene Ciloleucel at 2.0×10\\^6\u002FKg",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Zhang, PhD","CONTACT","86-0371-66279567","fcczhangxd@zzu.edu.cn",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The First Affiliated Hospital of Zhengzhou University, Department of Oncology","RECRUITING","Zhengzhou","Henan","450052","China","CN",{"type":36,"coordinates":37},"Point",[38,39],113.64861,34.75778,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":24,"phoneExt":11,"email":25},"Xudong Zhang, PhD",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Mingzhi Zhang","Professor","100562910","phase-4-axicabtagene-ciloleucel-for-consolidation-after-first-line-treatment-of-high-risk-large-b-cell-lymphoma-100562910",false,"NCT06609304","Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma","Prospective Clinical Study of Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma","axi-cel","Inclusion Criteria:\n\n1. Understand and voluntarily sign the informed consent form;\n2. 18-70 years of age (inclusive);\n3. Previously untreated CD19-positive large B-cell lymphoma;\n4. Anticipated survival ≥12 weeks;\n5. Adequate bone marrow reserve prior to apheresis\n6. Appropriate organ function:\n7. Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 or 1; 8. Absence of CNS lymphoma;\n\n9\\. Negative blood\u002Furine pregnancy test in women of childbearing age.\n\nExclusion Criteria:\n\n1. History of allergy to any of the components of the cell product;\n2. History of stem cell transplantation;\n3. History of organ transplantation;\n4. Presence of active infections;\n5. Current or history of central nervous system disorders;\n6. Previous treatment with other modified T-cell therapy;\n7. Previous treatment with anti-CD19\u002FCD3 or other anti-CD19 therapies;\n8. Malignancies other than those indicated for this trial;\n9. History of any prior systemic immune checkpoint therapy;\n10. History of short-acting cell growth factors or haematopoietic agonists\u002Fstimulants ;\n11. History of a live vaccine within 3 months prior to screening;.","ALL","18 Years","70 Years",{"count":60,"type":61},20,"ESTIMATED","INTERVENTIONAL",[64],"PHASE4","The goal of this clinical trial is to learn if Axicabtagene Ciloleucel (axi-cel) works for consolidation after first-line treatment of high-risk Large B-cell Lymphoma (LBCL). It will also learn about the safety of axi-cel treatment. The main questions it aims to answer are:\n\n* Does axi-cel treatment result in prolonged clinical benefit to patients with high-risk LBCL after first-line treatment?\n* What medical problems do participants have when receiving axi-cel treatment?\n\nIn this investigator-initiated, single-arm clinical trial, participants will:\n\n* Receive atezolizumab treatment at 2.0×10\\^6 cells\u002FKg as a one-time therapy.\n* Visit the clinic as instructed for checkups and tests.",[67],"Lymphoma, B-Cell","2024-10-09",{"date":70,"type":71},"2024-10-15","ACTUAL",{"date":73,"type":61},"2024-09-30",{"date":75,"type":61},"2027-08-31",{"name":5,"class":6},1]