Nctid:
NCT06233526
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007938", "term"=>"Leukemia"}, {"id"=>"D000007951", "term"=>"Leukemia, Myeloid"}, {"id"=>"D000015470", "term"=>"Leukemia, Myeloid, Acute"}, {"id"=>"D000006967", "term"=>"Hypersensitivity"}], "ancestors"=>[{"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000006402", "term"=>"Hematologic Diseases"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M10018", "name"=>"Hypersensitivity", "asFound"=>"Sensitivity", "relevance"=>"HIGH"}, {"id"=>"M10945", "name"=>"Leukemia", "asFound"=>"Leukemia", "relevance"=>"HIGH"}, {"id"=>"M18127", "name"=>"Leukemia, Myeloid, Acute", "asFound"=>"Acute Myeloid Leukemia", "relevance"=>"HIGH"}, {"id"=>"M10955", "name"=>"Leukemia, Myeloid", "asFound"=>"Myeloid Leukemia", "relevance"=>"HIGH"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"T3995", "name"=>"Myeloid Leukemia", "asFound"=>"Myeloid Leukemia", "relevance"=>"HIGH"}, {"id"=>"T182", "name"=>"Acute Myeloid Leukemia", "asFound"=>"Acute Myeloid Leukemia", "relevance"=>"HIGH"}, {"id"=>"T188", "name"=>"Acute Non Lymphoblastic Leukemia", "asFound"=>"Acute Myeloid Leukemia", "relevance"=>"HIGH"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>60}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-06", "completionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-06-30", "studyFirstSubmitDate"=>"2024-01-23", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-07-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Complete remission rate", "timeFrame"=>"4 weeks", "description"=>"Complete remission rate after the course of individualized treatment"}, {"measure"=>"Event free survival", "timeFrame"=>"one year, five years", "description"=>"The patient's event free survival at one and five years after treatment"}], "secondaryOutcomes"=>[{"measure"=>"Overall Survival", "timeFrame"=>"one year, five years", "description"=>"The patient's overall survival at one and five years after treatment"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Acute myeloid leukemia", "relapsed/refractory", "transcriptomic sequencing", "drug sensitivity test"], "conditions"=>["Acute Myeloid Leukemia in Children"]}, "referencesModule"=>{"references"=>[{"pmid"=>"34615640", "type"=>"BACKGROUND", "citation"=>"Newell LF, Cook RJ. Advances in acute myeloid leukemia. BMJ. 2021 Oct 6;375:n2026. doi: 10.1136/bmj.n2026."}, {"pmid"=>"32719170", "type"=>"BACKGROUND", "citation"=>"Kim H. Treatments for children and adolescents with AML. Blood Res. 2020 Jul 31;55(S1):S5-S13. doi: 10.5045/br.2020.S002."}, {"pmid"=>"35668109", "type"=>"BACKGROUND", "citation"=>"Zarnegar-Lumley S, Caldwell KJ, Rubnitz JE. Relapsed acute myeloid leukemia in children and adolescents: current treatment options and future strategies. Leukemia. 2022 Aug;36(8):1951-1960. doi: 10.1038/s41375-022-01619-9. Epub 2022 Jun 6."}, {"pmid"=>"34547866", "type"=>"BACKGROUND", "citation"=>"Leukemia & Lymphoma Group, Chinese Society of Hematology, Chinese Medical Association. [Chinese guidelines for the diagnosis and treatment of relapsed/refractory acute myelogenous leukemia (2021)]. Zhonghua Xue Ye Xue Za Zhi. 2021 Aug 14;42(8):624-627. doi: 10.3760/cma.j.issn.0253-2727.2021.08.002. No abstract available. Chinese."}, {"pmid"=>"36781850", "type"=>"BACKGROUND", "citation"=>"Kamens JL, Nance S, Koss C, Xu B, Cotton A, Lam JW, Garfinkle EAR, Nallagatla P, Smith AMR, Mitchell S, Ma J, Currier D, Wright WC, Kavdia K, Pagala VR, Kim W, Wallace LM, Cho JH, Fan Y, Seth A, Twarog N, Choi JK, Obeng EA, Hatley ME, Metzger ML, Inaba H, Jeha S, Rubnitz JE, Peng J, Chen T, Shelat AA, Guy RK, Gruber TA. Proteasome inhibition targets the KMT2A transcriptional complex in acute lymphoblastic leukemia. Nat Commun. 2023 Feb 13;14(1):809. doi: 10.1038/s41467-023-36370-x. Erratum In: Nat Commun. 2023 Mar 9;14(1):1297. doi: 10.1038/s41467-023-37141-4."}, {"pmid"=>"37714925", "type"=>"RESULT", "citation"=>"Du W, Xia Z, Luo Z, Chen Y, Bing S, Wang W, Zhang X, Zhou Z, Zhang J, Cao J, Yang B, He Q, Shao X, Xu X, Ying M. A novel gene fusion RUNX1/ZNF423 promotes leukemic relapse of NUP98-rearranged AML. Leukemia. 2023 Nov;37(11):2286-2291. doi: 10.1038/s41375-023-02024-6. Epub 2023 Sep 15. No abstract available."}]}, "descriptionModule"=>{"briefSummary"=>"Acute myeloid leukemia (AML) accounts for about 15% to 20% of childhood leukemia, but the death rate accounts for about 50%. About 20-30% of children with AML did not achieve complete response (CR) after 2 induction treatments, and about 30% of children with CR had relapse within 3 years (including recurrence after hematopoietic stem cell transplantation).Relapsed/refractory (R/R) AML is a major cause of treatment failure and refractory survival. Reinduction chemotherapy for R/R-AML to obtain CR again, followed by hematopoietic stem cell transplantation, is the current treatment. At present, there is no recognized reinduction protocol, and the reinduction remission rate of R/R-AML varies greatly among different treatment regimens, ranging from 23 to 81%. Current guidelines recommend a new combination chemotherapy regimen consisting of new drugs without cross-resistance. This method selects sensitive chemotherapeutic drugs, and then forms a new combination chemotherapy regimen according to the characteristics of drugs, which is the choice of R/R-AML reinduction therapy.This study intends to conduct a clinical study on the individualized treatment of R/R AML patients through in vitro drug sensitivity test combined with patient transcriptomic characteristics."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n- (1) Refractory recurrent acute myeloid leukemia (AML), and after second-line reinduction therapy, such as C+HAG did not reach complete CR.Criteria for complete response, refractory, and recurrence are as follows.\n\n(2) \\<18 years old; (3) The child had good organ function, could tolerate chemotherapy, and had a physical strength score of 0-3 (WHO standard); (4) Understand the research procedures and voluntarily sign written informed consent.\n\nExclusion Criteria:\n\n- (1) Acute promyelocytic leukemia, chronic myelogenous leukemia, acute mixed cell leukemia or known central nervous system leukemia; (2) AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Cole's syndrome, or congenital aplastic anemia; (3) secondary to immunodeficiency or positive for human immunodeficiency virus (HIV); (4) Cardiac and renal function were obviously abnormal, and left ventricular ejection fraction was \\<50%.\n\n(5) There is active systemic infection; (6) any medical history or concomitant condition that the investigator believes would impair the subject's safe completion of the study; (7) The investigator considers that the subject is medically unfit to receive the investigational drug or is unfit for any other reason; (8) a known or suspected allergy to the subject drug or to any drug administered in connection with this test;"}, "identificationModule"=>{"nctId"=>"NCT06233526", "briefTitle"=>"Individualized Treatment of Pediatric R/R AML Based on Transcriptomic Profile and in Vitro Drug Sensitivity Test", "organization"=>{"class"=>"OTHER", "fullName"=>"The Children's Hospital of Zhejiang University School of Medicine"}, "officialTitle"=>"Individualized Treatment of Pediatric Relasped and Refractory Acute Myeloid Leukemia Based on Transcriptomic Profile and in Vitro Drug Sensitivity Test", "orgStudyIdInfo"=>{"id"=>"2023-IRB-0315-P-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Individualized treatment group", "description"=>"Treating the R/R AML patients based on the transcriptomic profile and in vitro drug sensitivity Test", "interventionNames"=>["Other: Chemotherapy regiments based on the transcriptomic profile and in vitro drug sensitivity test"]}], "interventions"=>[{"name"=>"Chemotherapy regiments based on the transcriptomic profile and in vitro drug sensitivity test", "type"=>"OTHER", "description"=>"1. Leukemia cells from newly diagnosed and relapsed children with AML were tested for high throughput in vitro drug sensitivity and resistance.\n2. Combined with multi-omics sequencing technology such as whole exome and transcriptome, the data of drug sensitivity, drug resistance and genomic characteristics of children AML patients were integrated, and the internal rules between drug sensitivity or drug resistance and molecular characteristics such as gene fusion, gene mutation and abnormal gene expression of children AML patients were deeply analyzed, and the molecular characteristics of drug sensitivity in children AML were mapped", "armGroupLabels"=>["Individualized treatment group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"310000", "city"=>"Hangzhou", "state"=>"Zhejiang", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Xu Xiaojun, chief physician", "role"=>"CONTACT", "email"=>"xuxiaojun@zju.edu.cn", "phone"=>"+86571888736617"}], "facility"=>"Children's Hospital of Zhejiang University School of Medicine", "geoPoint"=>{"lat"=>30.29365, "lon"=>120.16142}}], "centralContacts"=>[{"name"=>"Xiaojun Xu, MD", "role"=>"CONTACT", "email"=>"xuxiaojun@zju.edu.cn", "phone"=>"+8657188873617"}, {"name"=>"Meidan Ying, PhD", "role"=>"CONTACT", "email"=>"mying@zju.edu.cn", "phone"=>"+8657188208401"}], "overallOfficials"=>[{"name"=>"Xiaojun Xu, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Children's Hospital, Zhejiang University School of Medicine"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"The Children's Hospital of Zhejiang University School of Medicine", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"College of Pharmaceutical Science at Zhejiang University", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"chief physician", "investigatorFullName"=>"Xiaojun Xu", "investigatorAffiliation"=>"The Children's Hospital of Zhejiang University School of Medicine"}}}}
