[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491602":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":37,"centralContacts":42,"locations":51,"responsibleParty":82,"collaborators":84,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":29,"eligibilityCriteria":134,"healthyVolunteers":130,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":29,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":53,"whyStopped":29,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Children's Cancer Group, China","NETWORK",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard risk Arm A","EXPERIMENTAL","Any pediatric patients with newly diagnosed T-LBL Stage II to IV who achieve at least a PR at the end of Induction (EOI). Induction I followed by consolidation, Capizzi escalating methotrexate (interim maintenance) , delayed intensification and maintenance therapy. Triple intrathecal injections.",[13],"Drug: Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, methotrexate, Dexamethasone, Doxorubicin",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard risk Arm B","Any pediatric patients with newly diagnosed T-LBL Stage II to IV who achieve at least a PR at the end of Induction (EOI). Induction I followed by consolidation, high dose methotrexate (interim maintenance) , delayed intensification and maintenance therapy. Triple intrathecal injections.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"High Risk T-LBL","Any pediatric patients with newly diagnosed T-LBL Stage II to IV who fail to achieve at least a PR at the end of Induction (EOI). Induction I followed by 6 intensive polychemotherapy blocks (HR1'-HR2'-HR3'-HR1'-HR2'-HR3'), deIayed intensification, and maintenance therapy. Triple intrathecal injections.",[22],"Drug: Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, methotrexate, Dexamethasone, Doxorubicin, Vindesine, Etoposide, Ifosfamide",[24,30,33],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, methotrexate, Dexamethasone, Doxorubicin","Standard risk Arm A: Induction I followed by Consolidation, extracompartmental Capizzi MTX, delayed intensification and 96 weeks' maintenance therapy. Twenty-one or twenty-six triple intrathecal injections for CNS negative or positive patients, respectively.",[9],null,{"type":25,"name":26,"description":31,"armGroupLabels":32,"otherNames":29},"Standard risk Arm B: Induction I followed by Consolidation, extracompartmental high dose MTX, delayed intensification and 96 weeks' maintenance therapy. Twenty-one or twenty-six triple intrathecal injections for CNS negative or positive patients, respectively.",[15],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":29},"Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, methotrexate, Dexamethasone, Doxorubicin, Vindesine, Etoposide, Ifosfamide","High Risk T-LBL: Induction I followed by 2 cycles of BFM HR Blocks, delayed intensification and 96 weeks' maintenance therapy. Twenty-four or twenty-eight triple intrathecal injections for CNS negative or positive patients, respectively.",[19],[38],{"name":39,"affiliation":40,"role":41},"Yi-Jin Gao, MD","Shanghai Children's Medical Center","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":29,"email":47},"Yi-Jin Gao, M.D.","CONTACT","0086-21-38087513","gaoyijin@scmc.com.cn",{"name":49,"role":45,"phone":29,"phoneExt":29,"email":50},"Qing Quan, M.D","yuanqing@scmc.com.cn",[52,70],{"facility":40,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Shanghai","Shanghai Municipality","200127","China","CN",{"type":60,"coordinates":61},"Point",[62,63],121.45806,31.22222,{"lat":63,"lon":62},[66,67],{"name":39,"role":45,"phone":46,"phoneExt":29,"email":47},{"name":68,"role":45,"phone":69,"phoneExt":29,"email":50},"Qing Yuan, MD","0086-21-38626161",{"facility":71,"status":72,"city":73,"state":29,"zip":29,"country":57,"countryCode":58,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"West China Second University Hospital","NOT_YET_RECRUITING","Chengdu",{"type":60,"coordinates":75},[76,77],104.06667,30.66667,{"lat":77,"lon":76},[80],{"name":81,"role":45,"phone":29,"phoneExt":29,"email":29},"Xia Guo, MD",{"type":83,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[85,87,89,92,93,95,97,99,101,103,105,107,110,112,114,116,118,120,122,124,126],{"name":40,"class":86},"OTHER",{"name":88,"class":86},"Beijing Children's Hospital",{"name":90,"class":91},"Children's Hospital of Scow University","UNKNOWN",{"name":71,"class":86},{"name":94,"class":86},"Nanjing Children's Hospital",{"name":96,"class":86},"Qilu Hospital of Shandong University",{"name":98,"class":86},"Tianjin Medical University Cancer Institute and Hospital",{"name":100,"class":86},"Tongji Hospital",{"name":102,"class":86},"Xiangya Hospital of Central South University",{"name":104,"class":86},"The First Affiliated Hospital of Zhengzhou University",{"name":106,"class":91},"Cancer hospital of Shandong Province",{"name":108,"class":109},"Shenzhen Children's Hospital","OTHER_GOV",{"name":111,"class":86},"Wuhan Children's Hospital",{"name":113,"class":86},"The Children's Hospital of Zhejiang University School of Medicine",{"name":115,"class":86},"Shanghai Children's Hospital",{"name":117,"class":86},"Ruijin Hospital",{"name":119,"class":86},"The Second Hospital of Anhui Medical University",{"name":121,"class":86},"Children's Hospital of Hebei Province",{"name":123,"class":91},"Cancer Hospital of Henan Province",{"name":125,"class":86},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"name":127,"class":91},"Qilu Children's Hospital","100491602","phase-3-capizzi-escalating-methotrexate-versus-high-dose-methotrexate-in-children-with-newly-diagnosed-t-cell-lymphoblastic-lymphoma-t-lbl-100491602",false,"NCT05681260","Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)","A Randomized Trial Using a Modified COG ABFM Regimen Backbone to Investigate Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)","Inclusion Criteria:\n\n* Newly diagnosed T-lineage lymphoblastic lymphoma (T-LBL) Stage II-IV\n\nExclusion Criteria:\n\n* Patients with Down syndrome or primary immune comprised disease.\n* Ph+ T-LBL\n* Patients must not have received any prior cytotoxic chemotherapy\n* Any steroids pretreatment for \\> 5 days in the 7 days or for \\>14 days in the 28 days before the initiation of Induction chemotherapy. The dose of prednisone or methylprednisone pretreatment does not affect eligibility. Any steroids exposure that occurred \\> 28 days before the initiation of Induction chemotherapy is allowed. Inhalation and topical steroids are not considered pretreatment. A single dose of vincristine is allowed.","ALL","12 Months","18 Years",{"count":139,"type":140},200,"ESTIMATED","INTERVENTIONAL",[143],"PHASE3","T-cell lymphoblastic lymphoma (T-LBL) is the second most common subtype of non-Hodgkin lymphoma (NHL) in children and adolescents. With current treatment, event-free survival (EFS) rates vary between 75%\\~85%. Two different MTX intensification strategies are used commonly: HD-MTX with leucovorin rescue, and Capizzi-style MTX without leucovorin rescue plus PEG-ASP (C-MTX). Although superior outcome of patients with T-ALL receiving C-MTX compared with HD-MTX on the AALL0434 trial, the 2 approaches had not been compared directly in patients with T-LBL. There remains controversy on PET\u002FCT interpretation in children with NHL. Large prospective studies in pediatric patients with T-LBL regarding PET\u002FCT value for this is scarce. Around 1% pediatric patients with T-LBL will not achieve remission at the end of Induction (induction failure). The optimal treatment for this small subgroup is largely unclear. The BFM HR Blocks usually are applied to these patients even though the efficacy is unknown. Novel targeted therapies are needed for use. Dasatinib is identified as a targeted therapy for T-cell ALL in preclinical drug screening.",[146],"T-cell Lymphoblastic Lymphoma",[148,149,150,151,152,153,154,155],"T-cell lymphoblastic lymphoma","Pediatric","Capizzi-style Methotrexate","High dose Methotrexate","bortezomib","treatment","survival","PET scan","2026-03-17",{"date":158,"type":159},"2026-03-19","ACTUAL",{"date":161,"type":159},"2023-02-06",{"date":163,"type":140},"2029-12-31",{"name":5,"class":6},2]