[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07257419":3,"trial-entities:NCT07257419":162,"trial-summary:NCT07257419":168},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":68,"secondary_outcomes":77,"sex":96,"minimum_age":97,"maximum_age":98,"healthy_volunteers":99,"eligibility_criteria":100,"std_ages":131,"locations":134,"central_contacts":151,"overall_officials":153,"references":155,"see_also_links":156},"NCT07257419","HAPALL","CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+\u002FCD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed\u002FRefractory CD19+ ALL and Lymphoma","RECRUITING","2035-12","2026-08","2026-08-28","2026-10-03","St. Jude Children's Research Hospital","OTHER",true,"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.","This is a Phase I study evaluating the addback of CD19-CAR(Mem) T cells after TCRαβ+\u002FCD19 B cell depleted haploidentical donor transplantation for pediatric patients with relapsed\u002Frefractory CD19+ B-cell malignancies.\n\nDonors that meet eligibility criteria will be consented to undergo two separate collections: 1) G-CSF mobilized stem cell graft via apheresis for progenitor cell infusion and 2) Non-mobilized peripheral blood mononuclear cells (PBMC) via apheresis for subsequent CAR T-cell manufacturing and DLI if needed.\n\nPatients that meet eligibility criteria to receive therapy will be consented to proceed on study. Treatment will include a conditioning chemotherapy preparative regimen followed by 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, as well as collection of correlative samples.",[18,19,20],"Relapsed Pediatric ALL","Hematopoietic Cell Transplantation","Hematologic Malignancy",[22],"Relapsed\u002FRefractory ALL","INTERVENTIONAL","TREATMENT",[26],"PHASE1",{"count":28,"type":29},70,"ESTIMATED",[31,37,41,45,49,53,57,63],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Anti-Thymocyte Globulin (Rabbit)","Days -10, -11, -12.",[36],"HAPALL Treatment",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Cyclophosphamide","60 mg\u002Fkg intravenous once daily on day -9.",[36],{"type":32,"name":42,"description":43,"armGroupLabels":44},"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.",[36],{"type":32,"name":46,"description":47,"armGroupLabels":48},"Thiotepa","5 mg\u002Fkg intravenous twice daily on day -3.",[36],{"type":32,"name":50,"description":51,"armGroupLabels":52},"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.",[36],{"type":32,"name":54,"description":55,"armGroupLabels":56},"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.",[36],{"type":32,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"Filgrastim","G-CSF\\* 10 mcg\u002Fkg\u002Fday SC days 0, -1, -2, -3, -4, -5.",[36],[62],"G-CSF",{"type":64,"name":65,"description":66,"armGroupLabels":67},"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.",[36],[69,73],{"measure":70,"description":71,"timeFrame":72},"To assess the safety of combining CD19-CAR(Mem) T cells after TCRαβ+\u002FCD19 depleted haploidentical donor transplantation for pediatric patients with relapsed\u002Frefractory CD19+ B-cell malignancies.","The primary analysis will compute the sample proportions and corresponding binomial exact 95% confidence intervals among evaluable patients for the following toxicities (separately for each toxicity) within 100 days post-HCT: 1) Severe aGVHD defined as Grade 3-4 aGVHD 2) Severe CRS defined as Grade 4 CRS that does not resolve to grade 3 or lower within 72 hours of onset 3) Severe ICANS defined as Grade 4 ICANS that does not resolve to grade 3 or lower within 72 hours of onset 4) TRM defined as death without prior relapse or disease progression within 100 days post-HCT 5) Other toxicity data will also be reported for a complete safety assessment of the study regimen.","This will be assessed 100 days post-HCT",{"measure":74,"description":75,"timeFrame":76},"To assess the 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.","this will be measured by the failure to receive CD19-CAR(Mem) T cells among patients who received HCT. The number of patients who fail to receive addback will be reported as the proportion who were unable to receive addback within 60 days post-HCT","This will be assessed in the first 60 days post-HCT",[78,80,84,88,91,93],{"measure":74,"description":79,"timeFrame":76},"This will be measured by the failure to receive CD19-CAR(Mem) T cells among patients who received HCT. The number of patients who fail to receive addback will be reported as the proportion who were unable to receive addback within 60 days post-HCT",{"measure":81,"description":82,"timeFrame":83},"Estimate 1-year post-transplant relapse free survival","This this will be estimated by the Kaplan-Meier method","This will be assessed in the first 3 years post-HCT",{"measure":85,"description":86,"timeFrame":87},"Estimate cumulative incidence of neutrophil engraftment","This will be summarized by cumulative incidence functions estimated by the Kalbfleisch-Prentice method.","This will be assessed in the first 30 days post-HCT",{"measure":89,"description":86,"timeFrame":90},"Estimate cumulative incidence of platelet engraftment","This will be assessed in the first 100 days post-HCT",{"measure":92,"description":86,"timeFrame":83},"Estimate cumulative incidence of acute and chronic GVHD",{"measure":94,"description":86,"timeFrame":95},"Estimate cumulative incidence of immune-related adverse events","This will be assessed in the first 1 years post-HCT","ALL",null,"21 Years",false,{"inclusion":101,"exclusion":120,"raw_text":130},[102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119],"Age less than or equal to 21 years","High risk hematologic malignancy where allogeneic transplantation is the current standard of care. This includes (but is not limited to):","High risk CD19+ B cell ALL in CR1 or CR2","Any CD19+ B-cell ALL in CR3 or subsequent","If prior CNS leukemia, it must be treated and in CNS CR","Left ventricular ejection fraction \\> 40%, or shortening fraction ≥ 25%","Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml\u002Fmin\u002F1.73m2","Forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing","Karnofsky or Lansky (age dependent) performance score ≥ 50 (See APPENDIX A)","Bilirubin ≤ 3 times the upper limit of normal for age","Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age","At least single haplotype matched (≥ 4 of 8) family member","At least 18 years of age","HIV negative","If sexually active, agreement to use birth control until 2 weeks after completion of the mobilization and apheresis procedure","Regarding donation eligibility, is identified as either:","Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR","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",[121,122,123,124,125,126,127,128,129],"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","Any other active malignancy other than the one for which this HCT is indicated","Received a prior allogeneic HCT at any time","Pregnant, if female is of childbearing potential, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment","If sexually active, agreement to use birth control until 6 months after T cell infusion","Breast feeding","Any severe current uncontrolled bacterial, fungal or viral infection","Pregnant, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment if female","If female, breast feeding","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",[132,133],"CHILD","ADULT",[135],{"facility":12,"status":7,"city":136,"state":137,"zip":138,"country":139,"contacts":140,"geoPoint":148},"Memphis","Tennessee","38105","United States",[141,146],{"name":142,"role":143,"phone":144,"email":145},"Swati Naik, MBBS","CONTACT","888-226-4343","referralinfo@stjude.org",{"name":142,"role":147},"PRINCIPAL_INVESTIGATOR",{"lat":149,"lon":150},35.14953,-90.04898,[152],{"name":142,"role":143,"phone":144,"email":145},[154],{"name":142,"affiliation":12,"role":147},[],[157,159],{"label":12,"url":158},"http:\u002F\u002Fwww.stjude.org",{"label":160,"url":161},"Clinical Trials Open at St. Jude","http:\u002F\u002Fwww.stjude.org\u002Fprotocols",{"nct_id":4,"conditions":163,"biomarkers":166},[164,165],"Acute Lymphoblastic Leukemia","Hematologic Neoplasm",[167],"CD19 Gene",{"nct_id":4,"found":14,"summary":169,"prompt_version":179},{"design":170,"status":171,"heading":172,"summary":173,"follow_up":174,"word_count":175,"commitments":176,"compensation":177,"drugs_mentioned":178},"This is a Phase I study, meaning it's an early-stage study to test safety. It plans to enroll 70 participants.","completed","CD19-CAR T Cell Therapy After Transplant for Pediatric Leukemia and Lymphoma","This study is for children and young adults (up to 21 years old) with high-risk CD19-positive B-cell leukemia (ALL) or lymphoma that has come back or is hard to treat. It's looking at a new approach after a special type of stem cell transplant from a partially matched family member. The study will give a chemotherapy regimen including Anti-Thymocyte Globulin, Cyclophosphamide, Fludarabine, and Thiotepa, followed by a transplant. Then, patients will receive CD19-CAR T cells (a type of immunotherapy where a patient's own immune cells are modified to fight cancer). The main goals are to see if this combined treatment is safe and practical within the first 100 days after transplant.","Safety and feasibility will be assessed within 100 days post-transplant, with some assessments within the first 60 days. Longer-term survival and other outcomes will be estimated at 1 year.",111,"Participants will receive a conditioning chemotherapy regimen, followed by a stem cell transplant, and then an infusion of CD19-CAR T cells. They will be monitored for safety and effectiveness.","Not stated in the trial record.",[38,42,46],"v2"]