[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587957":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":24,"locations":30,"responsibleParty":43,"collaborators":23,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":23,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":23,"enrollmentInfo":55,"targetDuration":23,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":69,"whyStopped":23,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participant Group","EXPERIMENTAL","Participants will receive cyclophosphamide 500 mg\u002Fm\\^2\u002Fday intravenously (IV) and fludarabine 30 mg\u002Fm\\^2\u002Fday IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel（Axi-cel） administered as a single IV infusion at a target dose of 2 x 10\\^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells\u002Fkg on Day 0.",[13],"Drug: Axicabtagene Ciloleucel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Axicabtagene Ciloleucel","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells",[9],[21,22],"FKC-876","Axi-cel",null,[25],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Weili Zhao M.D. and Ph.D","CONTACT","+862164370045 ext 610707","zwl_trial@163.com",[31],{"facility":32,"status":23,"city":33,"state":34,"zip":35,"country":32,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":23},"China","Shanghai","Shanghai Municipality","200025","CN",{"type":38,"coordinates":39},"Point",[40,41],121.45806,31.22222,{"lat":41,"lon":40},{"type":44,"investigatorFullName":45,"investigatorTitle":5,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Zhao Weili","100587957","study-to-evaluate-the-efficacy-and-safety-of-axicabtagene-ciloleucel-injection-as-first-line-therapy-of-high-risk-large-b-cell-lymphoma-100587957",false,"NCT06935136","Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large B-Cell Lymphoma","A Single-Arm, Multicenter, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed LBCL (Large B-Cell Lymphoma) according to the WHO 2016 classification, including the following subtypes:DLBCL-NOS (Diffuse Large B-Cell Lymphoma, Not Otherwise Specified),HGBL (High-Grade B-Cell Lymphoma, including HGBL with MYC, BCL-2, and\u002For BCL-6 rearrangements (DHL\u002FTHL), HGBL-NOS),DLBCL transformed from follicular or marginal zone lymphoma, eligible if the patient has not previously received anthracycline-containing therapy\n* International Prognostic Index (IPI) score of 2-5 at initial diagnosis.\n* Individuals must have a positive interim positron emission tomography (PET) (Deauville PET score of 4 or 5) after 2 cycles (PET2+) of chemoimmunotherapy or high-risk ctDNA status (ctDNA levels not reduced by at least 2-log after two cycles of R-chemotherapy)\n* Age of 18 years or older.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* Adequate renal, hepatic, pulmonary, and cardiac function, defined as:\n\n  * Creatinine clearance (estimated by Cockcroft-Gault formula) ≥ 60 mL\u002Fmin\n  * Serum ALT\u002FAST ≤ 2.5 × Upper Limit of Normal (ULN)\n  * Total bilirubin ≤ 1.5 × ULN (except for patients with Gilbert's syndrome)\n  * Left ventricular ejection fraction ≥ 50%, no pericardial effusion as determined by echocardiography, and no clinically significant arrhythmias No clinically significant pleural effusion\n  * Baseline peripheral oxygen saturation \\> 92% under room air ventilation\n  * At least one measurable lesion.\n  * For women of childbearing potential, a negative serum pregnancy test is required (women who have undergone surgical sterilization or are postmenopausal for at least 2 years are considered not to be of childbearing potential).\n\nExclusion Criteria:\n\n* According to the WHO 2016 classification, patients with the following subtypes are excluded:\n\n  * LBCL with T-cell\u002Fhistiocyte-rich background\n  * Primary central nervous system DLBCL\n  * PMBCL (Primary Mediastinal B-Cell Lymphoma)\n  * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical HL (Hodgkin Lymphoma)\n  * Burkitt lymphoma\n  * History of Richter transformation in chronic lymphocytic leukemia\n* Presence of detectable malignant cells in the CSF (cerebrospinal fluid), brain metastases, or history of central nervous system involvement by lymphoma.\n\nPresence of cardiac involvement by lymphoma.\n\n* Prior treatment for LBCL other than two cycles of R-chemotherapy.\n* History of severe immediate hypersensitivity reaction to any of the drugs used in this study.\n* Presence of central nervous system disorders: history of stroke, transient ischemic attack, or reversible posterior leukoencephalopathy syndrome (PRES) within 12 months prior to enrollment.\n* History of acute or chronic active hepatitis B or C infection, unless HBV-DNA and HCV-RNA levels are below the level of detection.\n* Human immunodeficiency virus (HIV) positivity, unless on appropriate antiretroviral therapy with undetectable viral load by PCR and a CD4 count \\> 200 cells\u002FµL.\n* Any medical condition that may interfere with the assessment of the safety or efficacy of the study treatment.\n* History of clinically significant cardiac disease within 12 months prior to enrollment.\n* Any other condition deemed by the investigator as unsuitable for enrollment.","ALL","18 Years",{"count":56,"type":57},60,"ESTIMATED","INTERVENTIONAL",[60],"NA","The goal of this is Single-Arm, Multicenter, Open-Label Clinical Study is to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection(Axi-cel) as First-Line Therapy of High-Risk Large B-Cell Lymphoma.",[63,64],"CAR-T Cell Therapy","High-risk Large B-cell Lymphoma (LBCL)",[66,67,68],"axi-cel","car-t","LBCL","NOT_YET_RECRUITING","2025-04-21",{"date":72,"type":73},"2025-04-22","ACTUAL",{"date":75,"type":57},"2025-04-30",{"date":77,"type":57},"2028-04-09",{"name":5,"class":6},1]