[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"busulfan\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:busulfan":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100653864","phase-1-26dt052-scaling-busulfan-dose-to-body-surface-area-in-children-100653864",false,"NCT07792369","26DT052; Scaling Busulfan Dose to Body Surface Area in Children","Pilot Study of Scaling Busulfan Dose to Body Surface Area in Children Undergoing Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Subject age: ≤21 years\n2. Body Surface Area (BSA):\n\n   1. Group A: BSA ≥0.5 m2\n   2. Group B: BSA \\\u003C0.5 m2\n3. Planned for once-daily busulfan-containing conditioning regimen pre-bone marrow transplant\n4. Scheduled to have TDM after the first dose of busulfan\n5. Diagnosis: both benign and malignant conditions are eligible\n\nExclusion Criteria:\n\n1\\. At the time of enrollment, patients may not receive medications that significantly alter busulfan clearance, as specified below.\n\na. If patients had received the drugs listed below prior to enrollment, the following washout periods, based on ≥ 6 times drug t½, are required.\n\nDeferasirox: ≥7 days Metronidazole: ≥7 days Ketoconazole, voriconazole: ≥7 days Itraconazole, posaconazole: ≥14 days Phenytoin: ≥21 days","ALL","21 Years",{"count":19,"type":20},38,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this pilot study is to determine if scaling the first busulfan dose to Body Surface Area (BSA) in children with a BSA ≥0.5 m2 and using a BSA-banded dosing table for infants (BSA \\\u003C0.5 m2) increases the fraction of patients achieving a therapeutic drug exposure after the first dose.",[26,27,28,29,30],"Busulfan Pharmacokinetic Analysis","Busulfan Dosing","Hematopoietic Stem Cell Transplant (HSCT)","Busulfan","Glutathione",[32,29,27,33,34],"Hematopoietic Stem Cell Transplant","Body Surface Area","glutathione","NOT_YET_RECRUITING","2026-08-25",{"date":38,"type":39},"2026-08-28","ACTUAL",{"date":41,"type":20},"2026-09",{"date":43,"type":20},"2031-09",{"name":45,"class":46},"Children's Hospital of Philadelphia","OTHER"]