[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100347932":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":55,"collaborators":23,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":23,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":23,"maxAge":66,"enrollmentInfo":67,"targetDuration":23,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":23,"overallStatus":40,"whyStopped":23,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Children's Hospital of Philadelphia","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"TBI regimen","Standard of care myeloablative regimens will be used based on disease type and clinical status at time of transplant. Patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma will receive total body irradiation (TBI) regimen (thiotepa, cyclophosphamide, TBI).",[12],"Device: CliniMACS Cell Processing System for TCRαβ + T Cell and CD45RA Depleted Peripheral Stem Cell Addback",{"label":14,"type":6,"description":15,"interventionNames":16},"TBI or busulfan regimen","Standard of care myeloablative regimens will be used based on disease type and clinical status at time of transplant. Patients not diagnosed with ALL or lymphoblastic lymphoma may receive either total body irradiation (TBI) regimen (thiotepa, cyclophosphamide, TBI) or busulfan containing regimen (thiotepa, cyclophosphamide, busulfan).",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","CliniMACS Cell Processing System for TCRαβ + T Cell and CD45RA Depleted Peripheral Stem Cell Addback","Peripheral stem cell (PSC) product will be processed using the CliniMACS device for TCRαβ and T cell depletion. Approximately 10% of the PSCs will undergo CD45RA depletion and cryopreservation. Patients will receive CD45RA depleted infusion after the TCRab PSCT.",[14,9],null,[25],{"name":26,"affiliation":5,"role":27},"Timothy Olson, MD, PhD","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},"Megan Atkinson","CONTACT","215-590-2820","cttsbmtintake@chop.edu",{"name":35,"role":31,"phone":36,"phoneExt":23,"email":37},"Patricia Hankins, BSN, RN, CCRC","215-590-5168","hankinsp@chop.edu",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-75.16362,39.95238,{"lat":50,"lon":49},[53,54],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},{"name":35,"role":31,"phone":36,"phoneExt":23,"email":37},{"type":27,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Timothy Olson","Medical Director, Hematopoietic Stem Cell Transplantation (HSCT) Program","100347932","cd45ra-depleted-peripheral-stem-cell-addback-for-viral-or-fungal-infections-post-tcrcd19-depleted-hsct-100347932",false,"NCT03810196","CD45RA Depleted Peripheral Stem Cell Addback for Viral or Fungal Infections Post TCRαβ\u002FCD19 Depleted HSCT","CD45RA Depleted Peripheral Stem Cell Addback for Patients at Risk for Viral or Fungal Infections Post TCRαβ\u002FCD19 Depleted Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n1. Age: Patients \\\u003C25 years.\n2. First allogeneic HSCT only.\n3. Disease eligibility: Acute leukemias at high risk for relapse including positive minimal residual disease at end consolidation, high risk cytogenetics, or relapse. Hematologic malignancies including: acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, mixed lineage or bi-phenotypic leukemia, lymphoblastic or Burkitts, juvenile myelomonocytic leukemia\n4. Evaluation of organ and infectious status as per our Bone Marrow Transplant standard operating procedure (BMT SOP).\n5. Signed consent by parent\u002Fguardian or able to give consent if \\>18 years.\n\nExclusion Criteria:\n\n1. Patients who do not meet institutional disease, organ or infectious criteria\n2. No suitable donor available for mobilized peripheral stem cells\n3. Patients with genetic disorders including Fanconi anemia, Kostmann syndrome, dyskeratosis congenital or other DNA repair defects.\n4. Patients with Hodgkin lymphoma or non-Burkitts, non-lymphoblastic lymphoma\n5. Pregnant Participants\n\nDonor selection and eligibility\n\n1. Unrelated donor meets National Marrow Donor Program criteria for donation\n2. HLA testing\u002Fmatching\n3. Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection","ALL","25 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"NA","The major morbidities of allogeneic hematopoietic stem cell transplant with non-human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life threatening infections. T depletion of the donor hematopoietic stem cell graft is effective in preventing GVHD, but immune reconstitution is slow, increasing the risk of infections. An addback of donor CD45RA (naive T cells) depleted cells may improve immune reconstitution and help decrease the risk of infections.",[75,76,77,78,79,80,81,82],"Acute Leukemia","Acute Myeloid Leukemia","Myelodysplastic Syndromes","Acute Lymphoblastic Leukemia","Mixed Lineage Leukemia","Lymphoblastic Lymphoma","Burkitt Lymphoma","Juvenile Myelomonocytic Leukemia","2026-02-18",{"date":85,"type":86},"2026-02-20","ACTUAL",{"date":88,"type":86},"2019-03-01",{"date":90,"type":69},"2028-02",{"name":5,"class":6},1]