[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567843":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":52,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":25,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":25,"overallStatus":92,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TBICy","EXPERIMENTAL","Patients enrolled in this arm will receive total body irradiation plus cyclophosphamide as conditioning regimen.",[13],"Biological: TBICy",{"label":15,"type":16,"description":17,"interventionNames":18},"BuCy","ACTIVE_COMPARATOR","Patients enrolled in this arm will receive busulfan plus cyclophosphamide as conditioning regimen.",[19],"Biological: BuCy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","The TBI-Cy group was administered 250 mg\u002Fm2\u002Fd oral Me-CCNU on day -8. A total of 12 Gy TBI was for each patient and fractionated dose was 2 Gy twice daily or 4Gy once daily on days -8 to -6. Occluding of the lung fields during TBI, the corresponding irradiation dose reduced to a total of 8 Gy. On day -5, the schedule was intravenous 2 g\u002Fm2 Ara-C every 12 hours. Then intravenous 1.8 g\u002Fm2 CTX once per day from days -4 to -3.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The BuCy group received oral Me-CCNU 250 mg\u002Fm2\u002Fd twice daily on day -8, intravenous cytosine arabinoside (Ara-C) 2 g\u002Fm2 twice daily on day -7, intravenous Bu 3.2 mg\u002Fkg\u002Fd from days -6 to -4, and intravenous cyclophosphamide (CTX) 1.8 g\u002Fm2\u002Fd from days -3 to -2. There were no patients accepted oral Bu.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Yang Xu","CONTACT","86+051267781850","xuyang1020@126.com",[36],{"facility":5,"status":25,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Suzhou","Jiangsu","215000","China","CN",{"type":43,"coordinates":44},"Point",[45,46],120.59538,31.30408,{"lat":46,"lon":45},[49],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"type":51,"investigatorFullName":31,"investigatorTitle":5,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR",[53,55,57,59,61,63,65,67],{"name":54,"class":6},"Children's Hospital of Soochow University",{"name":56,"class":6},"Ruijin Hospital",{"name":58,"class":6},"Nanfang Hospital, Southern Medical University",{"name":60,"class":6},"Fujian Medical University Union Hospital",{"name":62,"class":6},"First Affiliated Hospital Xi'an Jiaotong University",{"name":64,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"name":66,"class":6},"Zhejiang University",{"name":68,"class":69},"Anhui Provincial Hospital","OTHER_GOV","100567843","phase-3-bucy-vs-tbicy-for-allo-hsct-in-t-all-patients-100567843",false,"NCT06673459","BuCy Vs. TBICy for Allo-HSCT in T-ALL Patients","Busulfan Plus Cyclophosphamide Vs. Total Body Irradiation Plus Cyclophosphamide for Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Acute T Lymphoblastic Leukemia: a Randomized Controlled, Open-label, Multi-center Clinical Trial","Inclusion Criteria:\n\n1. T-ALL patients aged \\> 2 years and ≤55 years;\n2. For the first time accept allo-HSCT;\n3. With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3; 4. Signing an informed consent form, having the ability to comply with study and follow-up procedures.\n\nExclusion Criteria:\n\n1. With other malignancies;\n2. With a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor T cell therapy;\n3. With uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation;\n4. With severe organ dysfunction;\n5. In pregnancy or lactation period;\n6. With any conditions not suitable for the trial (investigators' decision).","ALL","2 Years","55 Years",{"count":81,"type":82},430,"ESTIMATED","INTERVENTIONAL",[85],"PHASE3","T-cell acute lymphoblastic leukemia (T-ALL), a hematological malignant neoplasm of immature T cells, accounting for a morbidity of 10-15% among pediatric and 20-25% among adult patients of ALL. Despite the application of improved intensive therapies, the overall survival (OS) of T-ALL patients is still unsatisfactory, with a 5-year OS rate of less than 60% in adults and 85% in children. Over the past few decades, allogeneic hematopoietic stem-cell transplantation (allo-HSCT) has emerged as a potential and the most likely curative treatment for patients with high-risk hematological malignant neoplasms, and it has been proven that allo-HSCT could hold the potential to improve the prognosis of T-ALL patients and may even cure T-ALL.\n\nThe two most common myeloablative conditioning regimens for T-ALL patients with allo-HSCT were total body irradiation (TBI) plus cyclophosphamide (TBI-Cy) and busulfan (Bu) plus cyclophosphamide (BuCy). The most common use conditioning regimen for ALL patients is the TBI-Cy conditioning regimen over other hematological malignancy patients because TBI possess potent and distinct anti-leukemic effects, particularly in organs not easily affected by systemic chemotherapy and intense immunosuppressive effects. However, TBI-based conditioning regimens may cause a high risk of cataracts, interstitial pneumonitis (IP), engraftment failure and even subsequent malignant neoplasms (SMNs). To avoid these disadvantages, intravenous Bu replaced TBI as a part of conditioning.\n\nExtensive studies have shown that allo-HSCT with conditioning regimens based on TBI could benefit survival compared with conditioning regimens based on chemotheraphy in treating ALL. We retrospectively analyzed post-10-year data from T-ALL patients from two transplant centers, and all the databases were used to eliminate confounding factors via PSM. We demonstrated that the TBI-Cy conditioning regimen had inferior efficacy to the BuCy conditioning regimen, especially for T-ALL patients who were children, refractory, had extramedullary disease before transplantation, had active disease or an MRD-positive status at allo-HSCT, or who received haplo-HSCT.",[88,89,90,91],"T-Cell Lymphocytic Leukemia","ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","Total Body Irradiation","Chemotherapy","NOT_YET_RECRUITING","2024-11-02",{"date":95,"type":96},"2024-11-05","ACTUAL",{"date":98,"type":82},"2024-12-01",{"date":100,"type":82},"2029-11-30",{"name":5,"class":6},1]