[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659687":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":44,"studyPopulation":31,"armGroups":45,"interventions":57,"overallOfficials":68,"centralContacts":72,"locations":81,"responsibleParty":96,"collaborators":31,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":31,"eligibilityCriteria":104,"healthyVolunteers":101,"sex":105,"minAge":31,"maxAge":106,"enrollmentInfo":107,"targetDuration":31,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":83,"whyStopped":31,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Hong Kong Children's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Frequency of viral infections","Frequency of composite CMV, EBV and\u002For ADV infections within 100 days of HSCT","within 100 days after HSCT",[14,17,20,23,25,27,29],{"measure":15,"description":15,"timeFrame":16},"Overall survival","1 year",{"measure":18,"description":19,"timeFrame":16},"disease-free survival","survival without underlying disease recurrence or progression",{"measure":21,"description":21,"timeFrame":22},"Frequency of acute GVHD","100 days",{"measure":24,"description":24,"timeFrame":16},"Cumulative incidence of chronic GVHD",{"measure":26,"description":26,"timeFrame":16},"Cumulative incidence of relapse of malignancy",{"measure":28,"description":28,"timeFrame":16},"Cumulative incidence of graft failure",{"measure":30,"description":30,"timeFrame":16},"Cumulative incidence of other adverse effects",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":35,"primaryPurpose":36,"observationalModel":31,"timePerspective":31,"maskingInfo":37},"RANDOMIZED","PARALLEL","randomised controlled trial","TREATMENT",{"masking":38,"maskingDescription":31,"whoMasked":39},"QUADRUPLE",[40,41,42,43],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the standard therapy for many malignant and non-malignant diseases in children. For patients lacking human leukocyte antigen (HLA)-matched donor, HLA-haploidentical family donor is an increasingly used alternative. In vitro T cell depletion can minimize graft-versus-host disease (GVHD) but increase the risk of infections, graft rejection and relapse of malignancy. CD45RA depleted donor lymphocyte infusion (DLI) can reduce these risks while reducing the risk of GVHD by removing naïve T cells but retaining memory T cells, and is currently one of the standard therapeutic options. The newly developed CD62L depletion may be an even better option that further reduces the risk of infection and GVHD as terminally differentiated CD45RA positive T cells (TEMRA) is retained while central memory T cells are depleted. In this randomized controlled trial, we aim to compare CD62L depleted DLI with CD45RA depleted DLI, in the context of T cell depleted haploidentical HSCT to treat children with malignant or non-malignant disease in need of HSCT. We shall evaluate the frequency of composite viral infections within 100 days of HSCT, overall and disease-free survivals, frequency of acute GVHD, and cumulative incidence of chronic GVHD, malignancy relapse, graft failure and other adverse effects.",[46,52],{"label":47,"type":48,"description":47,"interventionNames":49},"CD62L depleted DLI","EXPERIMENTAL",[50,51],"Biological: CD62L depleted DLI","Procedure: Haploidentical HSCT",{"label":53,"type":54,"description":53,"interventionNames":55},"CD45RA depleted DLI","ACTIVE_COMPARATOR",[56,51],"Biological: CD45RA depleted DLI",[58,61,63],{"type":59,"name":47,"description":47,"armGroupLabels":60,"otherNames":31},"BIOLOGICAL",[47],{"type":59,"name":53,"description":53,"armGroupLabels":62,"otherNames":31},[53],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":31},"PROCEDURE","Haploidentical HSCT","T cell depleted haploidentical HSCT",[53,47],[69],{"name":70,"affiliation":5,"role":71},"Daniel KL Cheuk, MBBS","PRINCIPAL_INVESTIGATOR",[73,77],{"name":70,"role":74,"phone":75,"phoneExt":31,"email":76},"CONTACT","852-35136049","cheukkld@hku.hk",{"name":78,"role":74,"phone":79,"phoneExt":31,"email":80},"Wilson YK Chan, MBBS","852-57413367","cyk956@ha.org.hk",[82],{"facility":5,"status":83,"city":84,"state":31,"zip":31,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"RECRUITING","Hong Kong","HK",{"type":87,"coordinates":88},"Point",[89,90],114.17469,22.27832,{"lat":90,"lon":89},[93,94,95],{"name":70,"role":74,"phone":75,"phoneExt":31,"email":76},{"name":78,"role":74,"phone":79,"phoneExt":31,"email":80},{"name":70,"role":71,"phone":31,"phoneExt":31,"email":31},{"type":71,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Cheuk Ka Leung Daniel","Consultant","100659687","phase-2-randomised-controlled-trial-comparing-cd62l-and-cd45ra-depleted-donor-lymphocyte-infusion-with-t-cell-depleted-haploidentical-hematopoietic-stem-cell-transplantation-100659687",false,"NCT07867769","Randomised Controlled Trial Comparing CD62L and CD45RA Depleted Donor Lymphocyte Infusion With T-cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Aged 0-18 years who requires allogeneic hematopoietic stem cell transplant, has no 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\n* Patients who are unlikely to benefit from haploidentical HSCT, e.g., terminal malignancy with multiorgan failure","ALL","18 Years",{"count":108,"type":109},46,"ESTIMATED","INTERVENTIONAL",[112],"PHASE2","The goal of clinical trial is to compare the efficacy and safety of CD62L depleted donor lymphocyte infusion (DLI) with CD45RA depleted DLI in children who receive T-cell depleted haploidentical hematopoietic stem cell transplantation (HSCT).\n\nParticipants will be randomised to receive either CD62L depleted DLI or CD45RA depleted DLI with HSCT and evaluate for efficacy and safety outcomes.",[115],"Hematopoietic Cell Transplantation",[117,118,119,120,35],"hematopoietic stem cell transplantation","CD62L depletion","CD45RA depletion","haploidentical transplant","2026-10-05",{"date":123,"type":124},"2026-10-09","ACTUAL",{"date":126,"type":124},"2026-10-02",{"date":128,"type":109},"2029-10-01",{"name":5,"class":6},1]