[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521897":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":46,"studyPopulation":39,"armGroups":47,"interventions":54,"overallOfficials":60,"centralContacts":64,"locations":69,"responsibleParty":82,"collaborators":84,"id":90,"slug":39,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":39,"eligibilityCriteria":94,"healthyVolunteers":91,"sex":95,"minAge":39,"maxAge":96,"enrollmentInfo":97,"targetDuration":39,"studyType":100,"phases":101,"briefSummary":102,"conditions":103,"keywords":39,"overallStatus":71,"whyStopped":39,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Hong Kong Children's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Graft failure-free, GVHD-free survival","From the date of treatment start until the date of graft failure or GVHD or death from any cause, whichever comes first, assessed up to 1 year","up to 1 year",[14,17,20,23,26,29,32,36],{"measure":15,"description":16,"timeFrame":12},"Overall survival","From the date of treatment start until the date of death from any cause, whichever comes first, assessed up to 1 year",{"measure":18,"description":19,"timeFrame":12},"Proportion of patients who develop relapse among those with malignant diseases","Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission",{"measure":21,"description":22,"timeFrame":12},"Proportion of patients who develop graft failure","Graft failure is defined as donor cells \\\u003C5% in whole blood",{"measure":24,"description":25,"timeFrame":12},"Proportion of patients who develop acute graft-versus-host disease","Acute graft-versus-host disease is defined by MAGIC criteria",{"measure":27,"description":28,"timeFrame":12},"Proportion of patients who develop chronic graft-versus-host disease","Chronic graft-versus-host disease is defined by NIH criteria",{"measure":30,"description":31,"timeFrame":12},"Proportion of patients who develop adverse events not mentioned in outcomes 4-6","Adverse events are graded according to Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5 (CTCAEv5)",{"measure":33,"description":34,"timeFrame":35},"Blood T lymphocyte count at 3 months","Mean T lymphocyte count in blood among evaluable patients","at 3 months",{"measure":37,"description":34,"timeFrame":38},"Blood T lymphocyte count at 1 year","at 1 year",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"NA","SINGLE_GROUP","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE","Radiotherapy at a dose of 6Gy divided into 3 equal fractions (2Gy per fraction) to all lymphoid organs (TLI) over 2 days using tomotherapy will be given to participants as part of the conditioning treatment before haploidentical hematopoietic stem cell transplantation (HSCT). Retrospective patients who are age- and disease-matched with the recruited patients and had received radiotherapy to the whole body (TBI) with or without lung shielding at a total dose of 2-12 Gy delivered as 1-6 equal fractions by conventional opposed fields radiotherapy as part of conditioning will be compared for the outcomes.",[48],{"label":49,"type":50,"description":51,"interventionNames":52},"Treatment","EXPERIMENTAL","Total lymphoid irradiation (TLI)",[53],"Radiation: Total lymphoid irradiation",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":39},"RADIATION","Total lymphoid irradiation","Total lymphoid irradiation (TLI) 6Gy by tomotherapy as part of conditioning treatment before haploidentical hematopoietic stem cell transplant",[49],[61],{"name":62,"affiliation":5,"role":63},"Daniel Cheuk","PRINCIPAL_INVESTIGATOR",[65],{"name":62,"role":66,"phone":67,"phoneExt":39,"email":68},"CONTACT","852-35136049","cheukkld@gmail.com",[70],{"facility":5,"status":71,"city":72,"state":39,"zip":39,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"RECRUITING","Hong Kong","HK",{"type":75,"coordinates":76},"Point",[77,78],114.17469,22.27832,{"lat":78,"lon":77},[81],{"name":62,"role":66,"phone":67,"phoneExt":39,"email":68},{"type":83,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[85,87],{"name":86,"class":6},"The University of Hong Kong",{"name":88,"class":89},"Hong Kong Sanatorium & Hospital","INDUSTRY","100521897",false,"NCT06075563","Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Aged 0-18 years who requires allogeneic HSCT, has no human leukocyte antigen (HLA)-matched sibling donor but has an HLA-haploidentical donor.\n* Adequate organ function to tolerate the conditioning chemotherapy and radiotherapy\n* Karnofsky or Lansky performance status score ≥50\n\nExclusion Criteria:\n\n* Pregnant or lactating woman\n* HIV infection\n* Patients for whom alternative treatment is deemed more appropriate by treating physician\n* Patients who are unlikely to benefit from haploidentical hematopoietic stem cell transplantation, e.g., terminal malignancy with multiorgan failure","ALL","18 Years",{"count":98,"type":99},23,"ESTIMATED","INTERVENTIONAL",[41],"In this comparative study, the investigators aim to compare prospective pediatric patients who receive total lymphoid irradiation (TLI) using tomotherapy with age- and disease-matched controls who receive conventional total body irradiation (TBI) as part of conditioning for haploidentical hematopoietic stem cell transplantation (HSCT) for both malignant and non-malignant diseases. The investigators shall evaluate graft failure-free, graft-versus-host disease (GVHD)-free survival, overall survival, frequency of rejection, GVHD, relapse of malignancy, adverse effects and post-transplant immunoreconstitution.",[104],"Hematopoietic Organs; Disorder","2025-09-03",{"date":107,"type":108},"2025-09-10","ACTUAL",{"date":110,"type":108},"2023-05-29",{"date":112,"type":99},"2026-12",{"name":5,"class":6},1]