[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612733":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":59,"centralContacts":63,"locations":68,"responsibleParty":85,"collaborators":27,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":27,"eligibilityCriteria":92,"healthyVolunteers":89,"sex":93,"minAge":27,"maxAge":94,"enrollmentInfo":95,"targetDuration":27,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":70,"whyStopped":27,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"St. Jude Children's Research Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HAPALL Treatment","EXPERIMENTAL","Patients receive a conditioning regimen that will comprise of ATG, Fludarabine, Cyclophosphamide. Melphalan and Thiotepa. Following the conditioning regimen, patients receive infusion of TCRαβ+\u002FCD19 B cell depleted progenitor cell infusion on day 0. Then as early as day + 14 patients will receive the previously manufactured CD19-CAR(Mem) T cell product. Patients will then be monitored for safety and efficacy of the infused CAR T-cell product,\n\nCells for infusion are prepared using the CliniMACS system.",[13,14,15,16,17,18,19,20],"Drug: Anti-Thymocyte Globulin (Rabbit)","Drug: Cyclophosphamide","Drug: Fludarabine","Drug: Thiotepa","Drug: Mesna","Drug: Melphalan","Drug: Filgrastim","Device: CliniMACS System",[22,28,32,36,40,44,48,54],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Anti-Thymocyte Globulin (Rabbit)","Days -10, -11, -12.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Cyclophosphamide","60 mg\u002Fkg intravenous once daily on day -9.",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Fludarabine","30 mg\u002Fm2 intravenous once daily for \\>10 kg, 1 mg\u002Fkg intravenous once daily for ≤10 kg on days -4, -5, -6, -7, -8.",[9],{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Thiotepa","5 mg\u002Fkg intravenous twice daily on day -3.",[9],{"type":23,"name":41,"description":42,"armGroupLabels":43,"otherNames":27},"Mesna","Mesna is planned to be administered at 15 mg\u002Fkg\u002Fdose prior to cyclophosphamide and at approximately 3, 6, and 9 hours after the cyclophosphamide infusion, to give a 1:1 ratio of mesna:cyclophosphamide.",[9],{"type":23,"name":45,"description":46,"armGroupLabels":47,"otherNames":27},"Melphalan","70 mg\u002Fm2 intravenous once daily for \\>10 kg, 2.3 mg\u002Fkg intravenous once daily for ≤10 kg on days -1, and -2.",[9],{"type":23,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Filgrastim","G-CSF\\* 10 mcg\u002Fkg\u002Fday SC days 0, -1, -2, -3, -4, -5.",[9],[53],"G-CSF",{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":27},"DEVICE","CliniMACS System","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],[60],{"name":61,"affiliation":5,"role":62},"Swati Naik, MBBS","PRINCIPAL_INVESTIGATOR",[64],{"name":61,"role":65,"phone":66,"phoneExt":27,"email":67},"CONTACT","888-226-4343","referralinfo@stjude.org",[69],{"facility":5,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"RECRUITING","Memphis","Tennessee","38105","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-90.04898,35.14953,{"lat":80,"lon":79},[83,84],{"name":61,"role":65,"phone":66,"phoneExt":27,"email":67},{"name":61,"role":62,"phone":27,"phoneExt":27,"email":27},{"type":86,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100612733","phase-1-cd45ra-depleted-cd19-car-t-cell-consolidation-after-tcrcd19-b-cell-depleted-haploidentical-hematopoietic-cell-transplantation-for-relapsedrefractory-cd19-all-and-lymphoma-100612733",false,"NCT07257419","CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+\u002FCD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed\u002FRefractory CD19+ ALL and Lymphoma","Inclusion Criteria:\n\nRecipient\n\n* Age less than or equal to 21 years\n* High risk hematologic malignancy where allogeneic transplantation is the current standard of care. This includes (but is not limited to):\n\n  * High risk CD19+ B cell ALL in CR1 or CR2\n  * Any CD19+ B-cell ALL in CR3 or subsequent\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* If sexually active, agreement to use birth control until 2 weeks after completion of the mobilization and apheresis procedure\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* 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* If sexually active, agreement to use birth control until 6 months after T cell infusion\n* Breast feeding\n* Any severe 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","ALL","21 Years",{"count":96,"type":97},70,"ESTIMATED","INTERVENTIONAL",[100],"PHASE1","The purpose of this study is to learn more about newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19 positive leukemia ALL.\n\nPrimary Objective:\n\n\\- To assess the safety and feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+\u002FCD19 depleted haploidentical donor transplantation for pediatric patients with relapsed\u002Frefractory CD19+ B-cell malignancies.\n\nSecondary Objectives:\n\n* To estimate 1-year post-transplant overall survival, event-free survival, and GVHD-free relapse-free survival (GRFS).\n* To estimate cumulative incidence of engraftment, acute and chronic GVHD, and immune-related adverse events, including CRS and ICANS.",[103,104,105],"Relapsed Pediatric ALL","Hematopoietic Cell Transplantation","Hematologic Malignancy",[107],"Relapsed\u002FRefractory ALL","2026-05-18",{"date":110,"type":111},"2026-05-19","ACTUAL",{"date":113,"type":97},"2026-06-03",{"date":115,"type":97},"2035-12",{"name":5,"class":6},1]