[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562910":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":11,"id":47,"slug":11,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"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,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"The First Affiliated Hospital of Zhengzhou University, Department of Oncology","RECRUITING","Zhengzhou","Henan","450052","China",{"type":35,"coordinates":36},"Point",[37,38],113.64861,34.75778,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":24,"phoneExt":11,"email":25},"Xudong Zhang, PhD",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Mingzhi Zhang","Professor","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":58,"type":59},20,"ESTIMATED","INTERVENTIONAL",[62],"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.",[65],"Lymphoma, B-Cell","2024-10-09",{"date":68,"type":69},"2024-10-15","ACTUAL",{"date":71,"type":59},"2024-09-30",{"date":73,"type":59},"2027-08-31",{"name":5,"class":6},1]