[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574819":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":45,"centralContacts":50,"locations":60,"responsibleParty":398,"collaborators":55,"id":400,"slug":401,"hasResults":402,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":402,"sex":408,"minAge":409,"maxAge":410,"enrollmentInfo":411,"targetDuration":55,"studyType":414,"phases":415,"briefSummary":418,"conditions":419,"keywords":423,"overallStatus":310,"whyStopped":55,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":435},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","After PVDL+CAT induction remission phase, patients randomized to Group A will be subjected to consolidation phase with continuous 28 days' blinatumomab followed by 3 cycles of high-dose methotrexate (HDMTX)",[13],"Drug: Blinatumomab (Group A)",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B","After PVDL+CAT induction remission phase, patients randomized to Group B will be subjected to consolidation phase with two 14-day cycles of blinatumomab, alternating with 3 cycles of high-dose methotrexate (HDMTX).",[18],"Drug: Blinatumomab (Group B)",{"label":20,"type":10,"description":21,"interventionNames":22},"NonRandonmized Group","Patients who will not be subjected to blinatomomab randomization, will received PVDL + Venetoclax + mini-hyperCVD as induction phase , subsequently receiving CAT as early intensification.",[23],"Drug: Venetoclax (nonRand Group)",[25,32,40],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Blinatumomab (Group A)","For Group A I\u002FHR-ALL patients after induction remission phase, continuous 28 days' blinatumomab followed by 3 cycles of high-dose methotrexate (HDMTX) will be applied, subsequently followed by interim continuation, late intensification, and maintenance therapy",[9],[31],"high-dose methotrexate",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Venetoclax (nonRand Group)","For I\u002FHR patients non eligible for blinatumomab randomization, venetoclax+ mini-hyperCVD will be applied after PVDL induction, subsequently followed by CAT as intensification, interim continuation, late intensification, and maintenance therapy",[20],[37,38,39],"cyclophosphamide","vincristine","dexamethasone",{"type":26,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Blinatumomab (Group B)","For Group B I\u002FHR-ALL patients after induction remission phase: a two 14-day cycles of blinatumomab, alternating with three cycles of HDMTX will be applied, subsequently followed interim continuation, late intensification, and maintenance therapy",[15],[31],[46],{"name":47,"affiliation":48,"role":49},"Xiaofan Zhu, MD","Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC","PRINCIPAL_INVESTIGATOR",[51,57],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Jingliao Zhang, MD","CONTACT","+86 22 23909196",null,"zhangjingliao@ihcams.ac.cn",{"name":47,"role":53,"phone":58,"phoneExt":55,"email":59},"+ 86 22 23909001","xfzhu@ihcams.ac.cn",[61,79,89,103,117,127,141,155,169,179,189,203,213,227,240,254,268,281,295,309,325,338,351,361,371,384],{"facility":62,"status":63,"city":64,"state":65,"zip":55,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Anhui Medical University Second Affiliated Hospital","NOT_YET_RECRUITING","Hefei","Anhui","China","CN",{"type":69,"coordinates":70},"Point",[71,72],117.28083,31.86389,{"lat":72,"lon":71},[75],{"name":76,"role":53,"phone":77,"phoneExt":55,"email":78},"Ningling Wang, 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PhD","027-83663131","aiguoliu309@163.com",{"facility":170,"status":63,"city":157,"state":158,"zip":55,"country":66,"countryCode":67,"cosmosGeoPoint":171,"geoPoint":173,"contacts":174},"Union Hospital of Tongji Medical College, Huazhong University of Science and Technology",{"type":69,"coordinates":172},[161,162],{"lat":162,"lon":161},[175],{"name":176,"role":53,"phone":177,"phoneExt":55,"email":178},"Xiaoyan Wu, PhD","027-85726114","xiaoyanw8016@163.com",{"facility":180,"status":63,"city":157,"state":158,"zip":55,"country":66,"countryCode":67,"cosmosGeoPoint":181,"geoPoint":183,"contacts":184},"Wuhan Children's Hospital",{"type":69,"coordinates":182},[161,162],{"lat":162,"lon":161},[185],{"name":186,"role":53,"phone":187,"phoneExt":55,"email":188},"Hao Xiong, MD","13006107360","22587481@qq.com",{"facility":190,"status":63,"city":191,"state":192,"zip":55,"country":66,"countryCode":67,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Hunan Children's 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Northwest Women and Children Hospital","Xi’an","Shanxi",{"type":69,"coordinates":286},[287,288],113.52486,35.99785,{"lat":288,"lon":287},[291],{"name":292,"role":53,"phone":293,"phoneExt":55,"email":294},"Jian Zhang, MD","029-89550001","kailipan@fmmu.edu.cn",{"facility":296,"status":63,"city":297,"state":298,"zip":55,"country":66,"countryCode":67,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"West China Second University Hospital, Sichuan University","Chengdu","Sichuan",{"type":69,"coordinates":300},[301,302],104.06667,30.66667,{"lat":302,"lon":301},[305],{"name":306,"role":53,"phone":307,"phoneExt":55,"email":308},"Ju Gao, MD","028-85503960","tree20002005@163.com",{"facility":48,"status":310,"city":311,"state":312,"zip":313,"country":66,"countryCode":67,"cosmosGeoPoint":314,"geoPoint":318,"contacts":319},"RECRUITING","Tianjin","Tianjin Municipality","300020",{"type":69,"coordinates":315},[316,317],117.17667,39.14222,{"lat":317,"lon":316},[320,322,323],{"name":47,"role":53,"phone":321,"phoneExt":55,"email":59},"+86 22 23909001",{"name":47,"role":49,"phone":55,"phoneExt":55,"email":55},{"name":52,"role":324,"phone":55,"phoneExt":55,"email":55},"SUB_INVESTIGATOR",{"facility":326,"status":63,"city":327,"state":55,"zip":55,"country":66,"countryCode":67,"cosmosGeoPoint":328,"geoPoint":332,"contacts":333},"Chongqing Medical University Affiliated Children's Hospital","Chongqing",{"type":69,"coordinates":329},[330,331],106.55771,29.56026,{"lat":331,"lon":330},[334],{"name":335,"role":53,"phone":336,"phoneExt":55,"email":337},"Jie Yu, MD","023-63632756","1808106657@qq.com",{"facility":339,"status":63,"city":340,"state":55,"zip":55,"country":66,"countryCode":67,"cosmosGeoPoint":341,"geoPoint":345,"contacts":346},"Children's Hospital of Fudan University","Shanghai",{"type":69,"coordinates":342},[343,344],121.45806,31.22222,{"lat":344,"lon":343},[347],{"name":348,"role":53,"phone":349,"phoneExt":55,"email":350},"Xiaowen Zhai, MD","021-64931990","zhaixiaowendy@163.com",{"facility":352,"status":63,"city":340,"state":55,"zip":55,"country":66,"countryCode":67,"cosmosGeoPoint":353,"geoPoint":355,"contacts":356},"Shanghai Children's Hospital",{"type":69,"coordinates":354},[343,344],{"lat":344,"lon":343},[357],{"name":358,"role":53,"phone":359,"phoneExt":55,"email":360},"Hui Jiang, MD","021-62474880","jhui0111@126.com",{"facility":362,"status":63,"city":340,"state":55,"zip":55,"country":66,"countryCode":67,"cosmosGeoPoint":363,"geoPoint":365,"contacts":366},"Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine",{"type":69,"coordinates":364},[343,344],{"lat":344,"lon":343},[367],{"name":368,"role":53,"phone":369,"phoneExt":55,"email":370},"Shuhong Shen, MD","021-3862616","shenshuhong@scmc.com.cn",{"facility":372,"status":63,"city":373,"state":55,"zip":55,"country":66,"countryCode":67,"cosmosGeoPoint":374,"geoPoint":378,"contacts":379},"Shenzhen Children's Hospital","Shenzhen",{"type":69,"coordinates":375},[376,377],114.0683,22.54554,{"lat":377,"lon":376},[380],{"name":381,"role":53,"phone":382,"phoneExt":55,"email":383},"Sixi Liu, MD","83936101","tiger647@126.com",{"facility":385,"status":63,"city":386,"state":55,"zip":55,"country":386,"countryCode":387,"cosmosGeoPoint":388,"geoPoint":392,"contacts":393},"Hong Kong Children's Hospital","Hong Kong","HK",{"type":69,"coordinates":389},[390,391],114.17469,22.27832,{"lat":391,"lon":390},[394],{"name":395,"role":53,"phone":396,"phoneExt":55,"email":397},"Chi-kong Li, MD","(852) 3505-2849","ckli@cuhk.edu.hk",{"type":399,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","100574819","phase-2-newly-diagnosed-intermediatehigh-risk-pediatric-b-cell-all-protocol-100574819",false,"NCT06764238","Newly-diagnosed Intermediate\u002FHigh Risk Pediatric B-cell ALL Protocol","Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed for Intermediate\u002FHigh Risk Childhood B-cell ALL","CCCG-I\u002FHR-ALL","Inclusion Criteria:\n\n1. Age older than 1 month to younger than 18 years.\n2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.\n3. Diagnosis of B-ALL by immunophenotyping.\n\nExclusion Criteria:\n\n1. Low-risk ALL\n2. sIgM+\n3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.\n4. ALL evolved from chronic myeloid leukemia (CML).\n5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction\n6. Secondary leukemia\n7. Known underlying congenital immunodeficiency or metabolic disease\n8. Congenital heart disease with cardiac insufficiency.\n9. Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \\> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)","ALL","1 Month","18 Years",{"count":412,"type":413},1800,"ESTIMATED","INTERVENTIONAL",[416,417],"PHASE2","PHASE3","Building upon the results from the CCCG-ALL-2015, CCCG-ALL-2020 multicenter study cohort, concurrent research findings, and the latest clinical trials, the CCCG-ALL-2025 I\u002FHR-B-ALL is thus developed to further improve the event-free survival (EFS), and overall survival (OS), and quality of life (QoL) of children with intermediate- and high- risk B-cell childhood acute lymphoblastic leukaemia (I\u002FHR-B-ALL), while decreasing adverse reactions and transplantation rates. This trial primarily aims to explore:\n\n1. The efficacy of two randomized Blinatumomab application scheme on I\u002FHR-ALL as determined by MRD negatvitiy rate.\n2. The efficacy of modified mini-hyperCVD + Venetoclax in I\u002FHR-ALL cannot afford blinatumomab, in contrast to historical control as determined by MRD negatvitiy rate.",[420,421,422],"Acute Lymphoblastic Leukemia ALL","Childhood Leukemia, Acute Lymphoblastic","B Cell Acute Lymphoblastic Leukemia (B-ALL)",[424,425],"blinatimomab","venetoclax","2025-02-04",{"date":428,"type":429},"2025-02-07","ACTUAL",{"date":431,"type":429},"2025-01-03",{"date":433,"type":413},"2031-06",{"name":5,"class":6},26]