[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533120":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":89,"centralContacts":94,"locations":104,"responsibleParty":305,"collaborators":98,"id":308,"slug":309,"hasResults":310,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":310,"sex":316,"minAge":98,"maxAge":317,"enrollmentInfo":318,"targetDuration":98,"studyType":321,"phases":322,"briefSummary":324,"conditions":325,"keywords":328,"overallStatus":220,"whyStopped":98,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},{"fullName":5,"class":6},"Children's Hospital of Soochow University","OTHER",[8,20],{"label":9,"type":10,"description":11,"interventionNames":12},"SDC group","EXPERIMENTAL","Patients with CBF fusion gene (RUNX1: : RUNX1T1 and CBFB: : MYH11) or KMT2A: : MLLT3(AF9) , KMT2A: : MLLT10(AF10) , KMT2A: : MLLT4(AF6) fusion gene or KIT mutation will receive SDC regimen, including one course of HAE (Homoharringtonine, cytarabine, etoposide) in induction I. These patients will continue on the SDC (HAE) regimen in the second course if the MRD is \\\u003C 1% after induction I, otherwise venetoclax will be added to the SDC group sequentially on Day 2 after the end of HAE. FLT3-ITD will be given sorafenib or gilteritinib as early as possible, and patients with KIT mutations will be recommended to add avapritinib as appropriate. These targeted drugs will not be combined with venetoclax.",[13,14,15,16,17,18,19],"Drug: Homoharringtonine","Drug: Cytarabine","Drug: Etoposide","Drug: Venetoclax","Drug: Sorafenib","Drug: Gilteritinib","Drug: Avapritinib",{"label":21,"type":10,"description":22,"interventionNames":23},"LDC group","Patients with the exception of the CBF fusion gene (RUNX1: : RUNX1T1 and CBFB: : MYH11) or those with the KMT2A: : MLLT3(AF9) , KMT2A: : MLLT10(AF10) , KMT2A: : MLLT4(AF6) fusion gene or KIT mutation will receive the LDC (MAG\u002FIDAG+ venetoclax) regimen in induction I. Patients with MRD ≥1% or KIT mutations, assessed after induction I, will receive the HAE plus venetoclax (or targeted drugs) regimen, otherwise, they will receive MAG\u002FIDAG + venetoclax. FLT3-ITD will be given sorafenib or gilteritinib as early as possible, and patients with KIT mutations will be recommended to add avapritinib as appropriate. These targeted drugs will not be combined with venetoclax.",[14,24,25,26,17,18,19],"Drug: Mitoxantrone hydrochloride liposome","Drug: Recombinant Human Granulocyte Colony-Stimulating Factor","Drug: Idarubicin Hydrochloride",[28,35,41,47,53,59,65,71,77,83],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Homoharringtonine","3mg\u002Fm2\u002Fday for weighing \\>10kg, 0.1mg\u002Fkg\u002Fday for weighing ≤10kg, d1-7, ivgtt, qd, more than 6 hours",[9],[34],"Homoharringtonine injection",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Cytarabine","100mg\u002Fm2\u002Fq12h for weighing \\>10kg, 3.3mg\u002Fkg\u002Fq12h for weighing ≤10kg, d1-7, ivgtt, q12h, more than 30 minutes in SDC group; 10mg\u002Fm2\u002Fq12h for weighing \\>10kg, 0.33mg\u002Fkg\u002Fq12h for weighing ≤10kg, d1-10, s.c.,q12h (the first dose at 8 am) in the LDC group;",[21,9],[40],"Cytosar",{"type":29,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Etoposide","100mg\u002Fm2\u002Fd for weighing \\>10kg, 3.3mg\u002Fkg\u002Fd for weighing ≤ 10kg, d1-5, ivgtt, qd, more than 4 hours",[9],[46],"Etoposide injection",{"type":29,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Venetoclax","100mg\u002Fm2\u002Fd for weighing \\>10kg, 3.33mg\u002Fkg\u002Fd for weighing ≤10kg, d12-25, po, qd",[9],[52],"Venclexta",{"type":29,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Mitoxantrone hydrochloride liposome","5mg\u002Fm2\u002Fd for weighing \\>10kg, 0.17mg\u002Fkg\u002Fd for weighing ≤ 10kg, d1, 3, 5, ivgtt, qod, more than 2 hours at 10 am.",[21],[58],"Mitoxantrone hydrochloride liposome injection",{"type":29,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"Recombinant Human Granulocyte Colony-Stimulating Factor","5ug\u002Fkg\u002Fd, d1-10, s.c., qd, at 1pm",[21],[64],"Recombinant Human Granulocyte Colony-Stimulating Factor Injection",{"type":29,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"Idarubicin Hydrochloride","3mg\u002Fm2\u002Fday for weighing \\>10kg, 0.1mg\u002Fkg\u002Fday for weighing ≤ 10kg, d1-7, ivgtt, qd, more than 6 hours.",[21],[70],"Idarubicin hydrochloride injection",{"type":29,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"Sorafenib","100mg\u002Fm2\u002Fday for weighing \\>10kg, 3.3mg\u002Fkg\u002Fday for weighing ≤10kg, from identification, po, qd",[21,9],[76],"Nexavar",{"type":29,"name":78,"description":79,"armGroupLabels":80,"otherNames":81},"Gilteritinib","20mg\u002Fm2\u002Fday for weighing \\>10kg, 0.7mg\u002Fkg\u002Fday for weighing ≤ 10kg, from identification, po, qd",[21,9],[82],"Xospata Pill",{"type":29,"name":84,"description":85,"armGroupLabels":86,"otherNames":87},"Avapritinib","50mg\u002Fm2\u002Fday for weighing bodyweight \\>10kg, 1.65mg\u002Fkg\u002Fday for weighing ≤ 10kg, po, qd",[21,9],[88],"AYVAKIT",[90],{"name":91,"affiliation":92,"role":93},"Shaoyan Hu, MD, PhD","Children 's Hospital of Soochow University","STUDY_CHAIR",[95,100],{"name":91,"role":96,"phone":97,"phoneExt":98,"email":99},"CONTACT","+86-13771870462",null,"hsy139@126.com",{"name":101,"role":96,"phone":102,"phoneExt":98,"email":103},"Li Gao, MD","+86-15821963190","joygaoli@163.com",[105,124,134,149,164,179,193,208,219,247,261,276,291],{"facility":106,"status":107,"city":108,"state":109,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":118,"contacts":119},"First Affiliated Hospital Of University of Science and Technology of China","NOT_YET_RECRUITING","Hefei","Anhui","230000","China","CN",{"type":114,"coordinates":115},"Point",[116,117],117.28083,31.86389,{"lat":117,"lon":116},[120],{"name":121,"role":96,"phone":122,"phoneExt":98,"email":123},"Hongjun Liu, MD","+86-13515657759","13515657759@126.com",{"facility":125,"status":107,"city":108,"state":109,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":126,"geoPoint":128,"contacts":129},"The Second Hospital of Anhui Medical University",{"type":114,"coordinates":127},[116,117],{"lat":117,"lon":116},[130],{"name":131,"role":96,"phone":132,"phoneExt":98,"email":133},"Ninglin Wang, MD","+86-13721113063","zwnltt@126.com",{"facility":135,"status":107,"city":136,"state":137,"zip":138,"country":111,"countryCode":112,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Guangzhou Women and Children Medical Center","Guangzhou","Guangdong","510000",{"type":114,"coordinates":140},[141,142],113.25,23.11667,{"lat":142,"lon":141},[145],{"name":146,"role":96,"phone":147,"phoneExt":98,"email":148},"Hua Jiang, MD","+86-13533330985","jiang_hua18@sina.cn",{"facility":150,"status":107,"city":151,"state":152,"zip":153,"country":111,"countryCode":112,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"The First Affiliated Hospital of Guangxi Medical University","Nanning","Guangxi","530000",{"type":114,"coordinates":155},[156,157],108.31667,22.81667,{"lat":157,"lon":156},[160],{"name":161,"role":96,"phone":162,"phoneExt":98,"email":163},"Ning Liao, MD","+86-13978812808","ln12808@163.com",{"facility":165,"status":107,"city":166,"state":167,"zip":168,"country":111,"countryCode":112,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Kaifeng Children's Hospital","Kaifeng","Henan","475000",{"type":114,"coordinates":170},[171,172],114.30742,34.7986,{"lat":172,"lon":171},[175],{"name":176,"role":96,"phone":177,"phoneExt":98,"email":178},"Jixia Luo, MD","+86-13592146539","luojixia@163.com",{"facility":180,"status":107,"city":181,"state":167,"zip":182,"country":111,"countryCode":112,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"The First Affiliated Hospital of Zhengzhou University","Zhengzhou","450052",{"type":114,"coordinates":184},[185,186],113.64861,34.75778,{"lat":186,"lon":185},[189],{"name":190,"role":96,"phone":191,"phoneExt":98,"email":192},"Yufeng Liu, MD","+86-13673666608","lyf6012@126.com",{"facility":194,"status":107,"city":195,"state":196,"zip":197,"country":111,"countryCode":112,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Third Xiangya Hospital of Central South University","Changsha","Hunan","410000",{"type":114,"coordinates":199},[200,201],112.97087,28.19874,{"lat":201,"lon":200},[204],{"name":205,"role":96,"phone":206,"phoneExt":98,"email":207},"Minghua Yang, MD","+86-13973135843","yamahua123@163.com",{"facility":209,"status":107,"city":195,"state":196,"zip":210,"country":111,"countryCode":112,"cosmosGeoPoint":211,"geoPoint":213,"contacts":214},"XiangYa Hospital Central South University","410008",{"type":114,"coordinates":212},[200,201],{"lat":201,"lon":200},[215],{"name":216,"role":96,"phone":217,"phoneExt":98,"email":218},"Liangchun Yang, MD","+86-13974927514","yangliangchung@163.com",{"facility":5,"status":220,"city":221,"state":222,"zip":223,"country":111,"countryCode":112,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"RECRUITING","Suzhou","Jiangsu","215000",{"type":114,"coordinates":225},[226,227],120.59538,31.30408,{"lat":227,"lon":226},[230,232,235,238,240,242,244,246],{"name":91,"role":96,"phone":231,"phoneExt":98,"email":99},"+8613771835430",{"name":233,"role":234,"phone":98,"phoneExt":98,"email":98},"Shaoyan Hu, MD,PhD","PRINCIPAL_INVESTIGATOR",{"name":236,"role":237,"phone":98,"phoneExt":98,"email":98},"Hailong HE, MD","SUB_INVESTIGATOR",{"name":239,"role":237,"phone":98,"phoneExt":98,"email":98},"YI Wang, MD,PhD",{"name":241,"role":237,"phone":98,"phoneExt":98,"email":98},"Jun Lu, MD,PhD",{"name":243,"role":237,"phone":98,"phoneExt":98,"email":98},"Peifang Xiao, MD,PhD",{"name":245,"role":237,"phone":98,"phoneExt":98,"email":98},"Jie Li, MD",{"name":101,"role":237,"phone":98,"phoneExt":98,"email":98},{"facility":248,"status":107,"city":249,"state":222,"zip":250,"country":111,"countryCode":112,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Xuzhou Children's Hospital","Xuzhou","221000",{"type":114,"coordinates":252},[253,254],117.28386,34.20442,{"lat":254,"lon":253},[257],{"name":258,"role":96,"phone":259,"phoneExt":98,"email":260},"Qi An, MD","+86-13814422329","anqi1974@sina.com",{"facility":262,"status":107,"city":263,"state":264,"zip":265,"country":111,"countryCode":112,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Qilu Hospital of Shandong University","Jinan","Shandong","250000",{"type":114,"coordinates":267},[268,269],116.99722,36.66833,{"lat":269,"lon":268},[272],{"name":273,"role":96,"phone":274,"phoneExt":98,"email":275},"Xiuli Ju, MD","+86-13869192944","shellysdcn@hotmail.com",{"facility":277,"status":107,"city":278,"state":279,"zip":280,"country":111,"countryCode":112,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"Children's Hospital Of Fudan University","Shanghai","Shanghai Municipality","200000",{"type":114,"coordinates":282},[283,284],121.45806,31.22222,{"lat":284,"lon":283},[287],{"name":288,"role":96,"phone":289,"phoneExt":98,"email":290},"Xiaowen Zhai, MD","+86-18017590808","zhaixiaowendy@163.com",{"facility":292,"status":107,"city":293,"state":98,"zip":294,"country":111,"countryCode":112,"cosmosGeoPoint":295,"geoPoint":299,"contacts":300},"Beijing Institute of Genomics, Chinese Academy of Sciences","Beijing","100000",{"type":114,"coordinates":296},[297,298],116.39723,39.9075,{"lat":298,"lon":297},[301],{"name":302,"role":96,"phone":303,"phoneExt":98,"email":304},"Qianfei Wang, PhD","+86-15611132448","wangqf@big.ac.cn",{"type":234,"investigatorFullName":306,"investigatorTitle":307,"investigatorAffiliation":5,"oldNameTitle":98,"oldOrganization":98},"Shaoyan Hu","Study Chair","100533120","phase-2-clinical-study-of-induction-therapy-options-based-on-molecular-subtyping-and-mrd-in-children-and-adolescents-with-aml-100533120",false,"NCT06221683","Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML","A Multicenter Clinical Study of Molecular Subtyping Combined With MRD-driven Remission Induction Regimen in Children and Adolescents With AML: A Phase II Cohort Study (GMCAII)","GMCAII","Inclusion Criteria:\n\n* 1、Newly diagnosed, untreated AML；\n* 2、Under 18 years old;\n* 3、Patients who have used hydroxyurea or cytarabine before diagnosis, but the dosage of cytarabine does not exceed 5 days, and the total dose does not exceed 500 mg\u002Fm2 (50 mg\u002Fm2, q12h × 5d)；\n* 4、 Liver function：Tbil≤2×ULN, ALT\u002FAST≤3×ULN, creatinine clearance ≥50ml\u002Fmin；Cardiac NYHA grading\\\u003C3；SaO2\\>92%;\n* 5、No active infection (symptoms resolved for more than 3 days if infected)\n* 6、ECOG\\\u003C2;\n* 7、Expected survival time greater than 12 weeks;\n* 9、Obtain the consent of the child and\u002For guardian and sign the informed consent form.\n\nExclusion Criteria:\n\n* 1、Acute megakaryocytic leukemia (AMKL)；\n* 2、Acute promyelocytic leukemia (APL);\n* 3、Treatment-related secondary AML and AML with definite MDS transformation；\n* 4、Myeloproliferative neoplasm (such as Juvenile myelomonocytic leukemia, JMML);\n* 5、AML secondary to congenital bone marrow failure (such as AML secondary to Fanconi anemia (FA)；\n* 6、AML secondary to Down syndrome;\n* 7、Only temporary chemotherapy, radiotherapy, or immunotherapy, but not systematic treatment according to the treatment plan;\n* 8、 Temporary chemotherapy, radiotherapy, or immunotherapy only, not systemic therapy per protocol;\n* 9、Having any significant abnormal concurrent disease or mental illness that impacts the life safety and compliance of the patient and impacts informed consent, study participation, follow-up, or interpretation of results. In this case, all the participating units are required to report directly to the responsible person for this project to jointly decide whether they meet the exclusion criteria；\n* 10、Patients with very poor nutritional status, severe infection, cardiac insufficiency, and intolerance to chemotherapy;\n* 11、Relapsed AML at any time；\n* 12、The attending physician considers that the patient is not suitable for entering the study protocol based on the patient's physical condition, economic status, and other factors.","ALL","18 Years",{"count":319,"type":320},500,"ESTIMATED","INTERVENTIONAL",[323],"PHASE2","The goal of this clinical trial is to estimate the rate (probability) of complete remission or complete remission with incomplete count recovery (CR\u002FCRi) with negative MRD after induction I and II, event-free survival (EFS), and cumulative incidence (probability) of relapse (CIR), in patients receiving molecular\u002Fprecision medicine and MRD-driven remission inductions, and to assess secondarily if there is an improvement over the AML2018 protocol.",[326,327],"AML, Childhood","Acute Myeloid Leukemia",[329,330,331,332],"AML","Childhood","Molecular subtyping","MRD","2024-08-21",{"date":335,"type":336},"2024-08-22","ACTUAL",{"date":338,"type":336},"2024-01-01",{"date":340,"type":320},"2029-12",{"name":5,"class":6},13]