[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536493":3},{"organization":4,"armGroups":7,"interventions":50,"overallOfficials":56,"centralContacts":56,"locations":88,"responsibleParty":108,"collaborators":56,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":56,"eligibilityCriteria":115,"healthyVolunteers":112,"sex":116,"minAge":56,"maxAge":56,"enrollmentInfo":117,"targetDuration":56,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":128,"overallStatus":91,"whyStopped":56,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8,16,21,27,32,36,41,46],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","With IDH1 gene mutation(up to 2 cycles available):IVA :\n\nIvosidenib 500mg d1-28 Azacitidine 75mg\u002Fm2\u002Fd d1-7 Venetoclax100mg d1, 200mg d2, 400mg d3, 800mg d4-14, d14-28(If the proportion of bone marrow blasts on day 14 is greater than 5% )",[13,14,15],"Drug: Ivosidenib","Drug: Venetoclax","Drug: Azacitidine",{"label":17,"type":10,"description":18,"interventionNames":19},"Arm 2","FLT3\u002FITD or FLT3\u002FTKD gene mutation (up to 2 cycles available)\n\nGVA:\n\nGilteritinib 80mg, d1-28 Azacitidine 75mg\u002Fm2\u002Fd d1-7 Venetoclax 100mg d1, 200mg d2, 400mg d3-14, 400mg d14-28 (if the proportion of bone marrow blasts on day 14 are greater than 5%)",[14,20,15],"Drug: Gilteritinib",{"label":22,"type":10,"description":23,"interventionNames":24},"Arm 3","For R\u002FR AML patients without IDH1 or FLT3 mutations who have not been exposed to Venecra in the last 3 months, the investigators will determine whether they are fit patients based on physical status and comorbidivities, and if they are, they can be randomly assigned to Arm3 or Arm4 DAV\u002FIAV\u002FMAV Cytarabine 100mg\u002Fm2\u002Fd, d1-5 Daunorubicin 60mg\u002Fm2\u002Fd, d1-2, or Idarubicin 12mg\u002Fm2\u002Fd, d1-2, or mitoxantrone 8mg\u002Fm2\u002Fd d1-2 Venetoclax 100mg d3, 200mg d4, 400mg d5-11;",[14,25,26],"Drug: Cytarabine","Drug: Daunorubicin\u002F Idarubicin \u002FMitoxantrone",{"label":28,"type":10,"description":29,"interventionNames":30},"Arm 4","HAV :\n\nCytarabine 100mg\u002Fm2\u002Fd, d1-5; Homoharringtonine 2mg\u002Fm2 d1-5; Venetoclax 100mg d3, 200mg d4, 400mg d5-11",[14,31,25],"Drug: Homoharringtonine",{"label":33,"type":10,"description":34,"interventionNames":35},"Arm 5","A patient with R\u002FR AML without IDH1 or FLT3 mutation who has not been exposed to Venetoclax in the last 3 months but who is judged by the investigators to be unfit based on physical fitness and comorbidivities is unfit to enter Arm5.\n\nArm5: (up to 4 cycles available)\n\nVA :\n\nAzacytidine 75mg\u002Fm2\u002Fd d1-7; Venetoclax 100mg d1, 200mg d2, 400mg d3-21 400mg d22-28 (if the proportion of bone marrow blasts on day 21 are greater than 5%)",[14,15],{"label":37,"type":10,"description":38,"interventionNames":39},"Arm 6","Patients with R\u002FR AML without IDH1 or FLT3 mutations who have been exposed to Vinecra within the last 3 months may be enrolled in the exploratory protocol group based on a comprehensive assessment of local drug availability and patient status:\n\nArm6:\n\nThe Investigator's choice (IC) option involves a range of drugs such as clatabine, PI3K inhibitors, histone deacetylase inhibitors, celinisol, and novel liposomes.",[40],"Drug: PI3K inhibitors, histone deacetylase inhibitors, selinexor, novel liposomal drugs, and others",{"label":42,"type":10,"description":43,"interventionNames":44},"Arm 7","DAV\u002FIAV\u002FMAV\u002FHAV Regimen Cytarabine 100 mg\u002Fm²\u002Fday, days 1-5 Daunorubicin 60 mg\u002Fm²\u002Fday, days 1-2, or Idarubicin 12 mg\u002Fm²\u002Fday, days 1-2, or Mitoxantrone 8 mg\u002Fm²\u002Fday, days 1-2 \u002F Homoharringtonine 2 mg\u002Fm²\u002Fday, days 1-5 Lisatoclax 200 mg on day 3, 400 mg on day 4, 600 mg on days 5-11",[31,25,26,45],"Drug: Lisaftoclax",{"label":47,"type":10,"description":48,"interventionNames":49},"Arm 8","Azacitidine 75 mg\u002Fm²\u002Fday, days 1-7 Lisatoclax 200 mg on day 1, 400 mg on day 2, 600 mg on days 3-21, and 600 mg on days 22-28 (if bone marrow blast percentage on day 21 is greater than 5%)",[15,45],[51,57,61,65,69,73,76,80,84],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"DRUG","Ivosidenib","in arm 1",[9],null,{"type":52,"name":58,"description":59,"armGroupLabels":60,"otherNames":56},"Venetoclax","in arms 2-5",[9,17,22,28,33],{"type":52,"name":62,"description":63,"armGroupLabels":64,"otherNames":56},"Gilteritinib","in arm 2",[17],{"type":52,"name":66,"description":67,"armGroupLabels":68,"otherNames":56},"Homoharringtonine","in arms 4 and 7",[28,42],{"type":52,"name":70,"description":71,"armGroupLabels":72,"otherNames":56},"Cytarabine","in arms 3 and 7",[22,28,42],{"type":52,"name":74,"description":71,"armGroupLabels":75,"otherNames":56},"Daunorubicin\u002F Idarubicin \u002FMitoxantrone",[22,42],{"type":52,"name":77,"description":78,"armGroupLabels":79,"otherNames":56},"Azacitidine","in arms 1，2 , 5 and 8",[9,17,33,47],{"type":52,"name":81,"description":82,"armGroupLabels":83,"otherNames":56},"Lisaftoclax","in arms 7 and 8",[42,47],{"type":52,"name":85,"description":86,"armGroupLabels":87,"otherNames":56},"PI3K inhibitors, histone deacetylase inhibitors, selinexor, novel liposomal drugs, and others","in arm 6",[37],[89],{"facility":90,"status":91,"city":92,"state":56,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Blood Hospital","RECRUITING","Tianjin","300020","China","CN",{"type":97,"coordinates":98},"Point",[99,100],117.17667,39.14222,{"lat":100,"lon":99},[103],{"name":104,"role":105,"phone":106,"phoneExt":56,"email":107},"hui wei, MD","CONTACT","86-13132507161","weihui@ihcams.ac.cn",{"type":109,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR","100536493","multicenter-platform-type-clinical-study-of-refractoryrecurrent-acute-myeloid-leukemia-100536493",false,"NCT06265545","Multicenter, Platform-type Clinical Study of Refractory\u002FRecurrent Acute Myeloid Leukemia","Inclusion Criteria:\n\n* 1\\. Patients with acute myeloid leukemia (except for acute promyelocytic leukemia) diagnosed by bone marrow cell morphology, immunology and genetics above are classified according to the French-British-American Collaboration diagnostic criteria (FAB criteria) and the World Health Organization diagnostic criteria (WHO2016 criteria).\n\n  2\\. Meet criteria for refractory\u002Frecurrent AML (except APL). The recurrence was morphological recurrence, excluding molecular recurrence. Except for simple extramedullary leukemia.\n\n  3\\. Age and gender are not limited. 4. Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family if he is 18 years old and above; For young patients under the age of 18, the legal guardian shall sign the informed consent. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.\n\nExclusion Criteria:\n\n1. Concurrent malignant tumors of other organs (patients requiring treatment).\n2. Participants considered unsuitable for inclusion by the researchers.","ALL",{"count":118,"type":119},458,"ESTIMATED","INTERVENTIONAL",[122],"NA","To study the optimal therapeutic strategies for salvage treatment of refractory\u002Frelapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R\u002FR AML with different treatment regimens.",[125,126,127],"AML","Refractory","Relapsed",[125,126,127],"2026-08-05",{"date":131,"type":132},"2026-08-07","ACTUAL",{"date":134,"type":132},"2024-02-22",{"date":136,"type":119},"2028-06-30",{"name":5,"class":6},1]