[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596968":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":55,"centralContacts":59,"locations":64,"responsibleParty":81,"collaborators":28,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":28,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":28,"maxAge":91,"enrollmentInfo":92,"targetDuration":28,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":66,"whyStopped":28,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"St. Jude Children's Research Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HAP3HCT Treatment","EXPERIMENTAL","Prior to the infusion of donor cells, a preparative regimen consisting of antibodies and chemotherapy will be given. The preparative regimen includes the following total dosages: ATG 5mg\u002Fkg (over days -12 to -10); Cyclophosphamide 60 mg\u002Fkg (day -9); Fludarabine 150 mg\u002Fm2 (over days -8 to -4); Thiotepa 10 mg\u002Fkg (divided in two doses on day -3); Melphalan 70 mg\u002Fm2 (over days -2 to -1). Following this regimen the TCRαβ-depleted haploidentical donor product will be given on day 0 (subsequent infusion given on day +1 if needed to achieve goal CD34+ cell dose. Approximately 2 weeks later the memory cell donor lymphocyte infusion (DLI) will be given at a dose previously determined to be safe and effective.\n\nBlinatumomab will be empirically added for patients with CD19+ malignancy and given at least four weeks after the memory cell DLI.",[13,14,15,16,17,18,19,20,21],"Drug: Thymoglobulin","Drug: Cyclophosphamide","Drug: Fludarabine","Drug: Thiotepa","Drug: Melphalan","Drug: Mesna","Drug: Filgrastim","Drug: Blinatumomab","Device: CliniMACS",[23,29,32,35,38,41,44,47,50],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Thymoglobulin","IV",[9],null,{"type":24,"name":30,"description":26,"armGroupLabels":31,"otherNames":28},"Cyclophosphamide",[9],{"type":24,"name":33,"description":26,"armGroupLabels":34,"otherNames":28},"Fludarabine",[9],{"type":24,"name":36,"description":26,"armGroupLabels":37,"otherNames":28},"Thiotepa",[9],{"type":24,"name":39,"description":26,"armGroupLabels":40,"otherNames":28},"Melphalan",[9],{"type":24,"name":42,"description":26,"armGroupLabels":43,"otherNames":28},"Mesna",[9],{"type":24,"name":45,"description":26,"armGroupLabels":46,"otherNames":28},"Filgrastim",[9],{"type":24,"name":48,"description":26,"armGroupLabels":49,"otherNames":28},"Blinatumomab",[9],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":28},"DEVICE","CliniMACS","The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest.",[9],[56],{"name":57,"affiliation":5,"role":58},"Brandon Triplett, MD","PRINCIPAL_INVESTIGATOR",[60],{"name":57,"role":61,"phone":62,"phoneExt":28,"email":63},"CONTACT","8662785833","referralinfo@stjude.org",[65],{"facility":5,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"RECRUITING","Memphis","Tennessee","38105","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-90.04898,35.14953,{"lat":76,"lon":75},[79],{"name":57,"role":61,"phone":80,"phoneExt":28,"email":63},"866-278-5833",{"type":82,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100596968","phase-1-tcr-depleted-progenitor-cell-graft-with-early-memory-t-cell-dli-plus-selected-use-of-blinatumomab-in-nave-t-cell-depleted-haploidentical-donor-hematopoietic-cell-transplantation-for-hematologic-malignancies-100596968",false,"NCT07052370","TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies","Inclusion Criteria:\n\nRecipient:\n\n* Age less than or equal to 21 years\n* High risk hematologic malignancy whereas allogeneic transplantation is the current standard of care. This includes (but is not limited to):\n\n  * High risk ALL in CR1 or CR2,\n  * any ALL in CR3 or subsequent;\n  * AML in high risk CR1 (AML diagnosis includes myeloid sarcoma),\n  * any AML in CR2 or subsequent,\n  * any therapy related AML;\n  * MDS (primary or secondary),\n  * NK cell, biphenotypic, or undifferentiated leukemia\u002Flymphoma in CR1 or subsequent;\n  * CML in accelerated phase, or in chronic phase with persistent molecular positivity or intolerance to tyrosine kinase inhibitor, or a history of blast crisis.\n* If prior CNS leukemia, it must be treated and in CNS CR\n* Left ventricular ejection fraction \\> 40%, or shortening fraction ≥ 25%\n* Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml\u002Fmin\u002F1.73m2\n* Forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing\n* Karnofsky or Lansky (age dependent) performance score ≥ 50 (See APPENDIX A)\n* Bilirubin ≤ 3 times the upper limit of normal for age\n* Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age\n\nDonor:\n\n* At least single haplotype matched (≥ 4 of 8) family member\n* At least 18 years of age\n* HIV negative\n* Regarding donation eligibility, is identified as either:\n\n  * Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR\n  * Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271\n\nExclusion Criteria:\n\nRecipient:\n\n* Has a suitable HLA-identical sibling or suitable 12\u002F12 (HLA-A, B, C, DRB1, DQB1, and DPB1) HLA-matched unrelated donor available in an appropriate time frame.\n* Any other active malignancy other than the one for which this HCT is indicated\n* Received a prior allogeneic HCT at any time\n* Received an autologous HCT within the previous 6 months\n* Pregnant, if female is of childbearing potential, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment\n* Breast feeding\n* Any current uncontrolled bacterial, fungal or viral infection\n\nDonor:\n\n* Pregnant, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment if female\n* If female, breast feeding",true,"ALL","21 Years",{"count":93,"type":94},30,"ESTIMATED","INTERVENTIONAL",[97],"PHASE1","This is a phase I, prospective clinical trial studying the safety and feasibility of providing early memory T-cell DLI.\n\nThe primary objective is:\n\n\\- To assess the safety and feasibility of early CD45RA-depleted DLI administration.\n\nThe secondary objectives are\n\n* To assess the safety and feasibility of the addition of blinatumomab in the early post-transplant period in patients with CD19+ malignancy.\n* To measure and describe the pharmacokinetics of rabbit ATG in HCT recipients on this study.",[100],"Hematologic Malignancy",[102],"Hematopoietic Cell Transplant","2026-06-01",{"date":105,"type":106},"2026-06-02","ACTUAL",{"date":108,"type":106},"2025-09-25",{"date":110,"type":94},"2030-12",{"name":5,"class":6},1]