[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphoblastic-leukemia-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphoblastic-leukemia-in-children":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,71,105,134],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100578383","phase-1-a-prospective-trial-of-dalbavancin-based-prophylaxis-in-children-and-adolescents-with-high-risk-leukemia-100578383",false,"NCT06810583","A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia","A Prospective, Single-Arm, Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia","Inclusion Criteria:\n\n* Aged less than or equal to 25 years at enrollment\n* Receiving treatment for AML or relapsed ALL at St. Jude and treatment is expected to cause prolonged (\\> 7 days) severe neutropenia (ANC \\\u003C 500\u002Fml)\n* Expected to receive care at St. Jude for at least 56 days following enrollment on the protocol\n* Female participant, greater than or equal to 9 years old, has a documented negative pregnancy test prior to receipt of study drug.\n\nExclusion Criteria:\n\n* Allergy to vancomycin, dalbavancin, teicoplanin, levofloxacin or ciprofloxacin (Not including non-anaphylactic vancomycin infusion reaction)\n* Documented past or current infection or colonization with pathogenic bacteria resistant to vancomycin plus either ciprofloxacin or levofloxacin\n* Diagnosed with long QT syndrome\n* Any condition judged by the investigator to put the participant at high risk from participation\n* Suspected or proven active bacterial infection\n* Inability to complete requirements of participation in the study (in the opinion of the investigator)\n* Expected survival \\\u003C28 days\n* Alkaline phosphatase, alanine transferase or total bilirubin ≥ 3x upper limit of normal for age\n* Estimated glomerular filtration rate (EGFR) \\\u003C30 mL\u002Fminute\u002F1.73 m2\n* Other absolute contraindication to administration of fluoroquinolone antibiotics or dalbavancin\n* Participant is pregnant or breastfeeding a child","ALL","25 Years",{"count":19,"type":20},29,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a single-arm pilot clinical trial evaluating dalbavancin-based prophylaxis in children and adolescents with acute myeloid leukemia or relapsed lymphoblastic leukemia receiving myelosuppressive chemotherapy.\n\nPrimary objective:\n\n\\- To estimate the rate of bacterial bloodstream infection in pediatric patients with AML or relapsed ALL undergoing chemotherapy receiving dalbavancin-based prophylaxis\n\nSecondary objectives:\n\n* To describe the population pharmacokinetics of every 28 days dalbavancin up to 12 weeks in pediatric patients with AML or relapsed ALL undergoing chemotherapy\n* To describe the tolerability of every 28 days dalbavancin prophylaxis in pediatric patients with AML or relapsed ALL undergoing chemotherapy\n* To describe the acceptability of every 28 days dalbavancin prophylaxis in pediatric patients with AML or relapsed ALL undergoing chemotherapy\n* To estimate the rates of likely bacterial infections, Clostridioides difficile infection, and febrile neutropenia in pediatric patients receiving dalbavancin-based prophylaxis",[26,27,28],"Leukemia","Acute Myeloid Leukemia","Lymphoblastic Leukemia in Children","RECRUITING","2026-02-02",{"date":32,"type":33},"2026-02-03","ACTUAL",{"date":35,"type":33},"2025-05-22",{"date":37,"type":20},"2031-09",{"name":39,"class":40},"St. Jude Children's Research Hospital","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100523720","phase-2-treatment-of-newly-diagnosed-standard-risk-acute-lymphoblastic-leukemia-in-children-100523720","NCT06099366","Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children","Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in","SR ALL","\\\u003CInclusion Criteria\\>\n\n* Newly diagnosed pediatric\u002Fadolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following\n\n  1. 1 year old ≤ Age \\\u003C 10 years old\n  2. white blood cell at initial diagnosis \\\u003C 5x10\\^10\u002FL (50,000uL)\n  3. No testis involvement\n  4. Satisfaction of following organ functions\n\nA. Kidney function (satisfies i or ii) i. Creatinine clearance (or radioisotope-measured GFR) ≥ 70mL\u002Fmin\u002F1.73m2 ii. Creatinine value according to age\u002Fsec satisfies the following:\n\n1 to \\\u003C 2 years: Male: 0.6 \u002F Female: 0.6, 2 to \\\u003C 6 years: Male: 0.8 \u002F Female: 0.8, 6 to \\\u003C 10 years: Male: 1 \u002F Female: 1, 10 to \\\u003C 13 years: Male: 1.2 \u002F Female: 1.2, 13 to \\\u003C 16 years: Male: 1.5 \u002F Female: 1.4, ≥ 16 years: Male: 1.7 \u002F Female: 1.4 However, subjects who meet the selection criteria within 1 week before registration after receiving appropriate conservative treatment, including fluid therapy, can be registered.\n\nB. Liver function i. Direct bilirubin \\\u003C 3.0mg\u002FdL\n\n\\\u003CExclusion Criteria\\>\n\n1. Steroid administration within 2 weeks before the registration\n2. t(9;22) or t(4;11)(q11;q23) or chromosome \\\u003C 44 or iAMP21 or t(17;19)\u002FTCF3-HLF\n3. Newly diagnosed T cell ALL\n4. One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome\n5. Burkitt leukemia\u002Flymphoma\n6. In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome\n7. When the clinical trial subject(or legal representative) does not consent or is unable to give written consent","1 Year","9 Years",{"count":53,"type":20},116,[55],"PHASE2","Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for high risk acute lymphoblastic leukemia in children and adolescents.",[28],[59,60],"Standard Risk ALL","NGS MRD","2025-06-04",{"date":63,"type":33},"2025-06-08",{"date":65,"type":33},"2024-03-05",{"date":67,"type":20},"2033-12-31",{"name":69,"class":40},"Hee Young Ju",9,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":89,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":104},"100489046","phase-2-cd19-directed-chimeric-antigen-receptor-car-t-cell-therapy-for-relapsedrefractory-b-lineage-leukaemia--lymphoma---a-feasibility-protocol-100489046","NCT05648019","CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed\u002FRefractory B-Lineage Leukaemia \u002F Lymphoma - A Feasibility Protocol","Inclusion Criteria:\n\n1. Eligible disease conditions:\n\n   1. Relapsed or refractory B-cell ALL (all must be satisfied)\n\n      * Presence of lymphoblasts in bone marrow aspirate by morphologic assessment or positive minimal residual disease at screening.\n      * Relapsed or refractory or ineligible for HSCT\n      * For relapsed B-ALL: Documentation of CD19 tumour expression (e.g. by flow cytometry) demonstrated in bone marrow or peripheral blood within 3 months of study entry\n   2. Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.\n2. Age at screening:\n\n   1. \\\u003C 18 years (paediatric group); or\n   2. ≥ 18 years (adult group)\n3. Adequate organ functions:\n4. Life expectancy more than 12 weeks.\n5. Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening.\n6. Must meet the institutional criteria to undergo leukapheresis or have a leukapheresis product of non-mobilized cells received and accepted by the manufacturing site.\n\nExclusion Criteria:\n\nPatients with any of the following will be excluded:\n\n* B-ALL with isolated extramedullary disease relapse\n* Patients with concomitant genetic syndrome: such as patients with Fanconi anaemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded.\n* Patients with Burkitt's lymphoma\u002Fleukaemia (i.e. patients with mature B-cell ALL; leukaemia with B-cell \\[sIg positive and kappa or lambda restricted positivity\\] ALL, with FAB L3 morphology and \u002For a MYC translocation)\n* Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening\n* Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening\n* Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD)\n* Active CNS involvement by malignancy, defined by CNS-3 per NCCN guidelines. Subjects with CNS-2 involvement or with history of CNS disease that have been actively treated are eligible.\n* Patient has an investigational medicinal product within the last 30 days prior to screening.\n* Pregnant or nursing women.\n* Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CAR T-cell infusion. All female patients of childbearing potential must have a negative pregnancy test performed within 48 hours before infusion of CAR T-cells.\n\nThe following are not strictly exclusion criteria but must be discussed with PI\u002FSite-PI:\n\n* Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease\n* Treatment with any prior gene therapy product\n* Has had treatment with any prior anti-CD19\u002Fanti-CD3 therapy, or any other anti-CD19 therapy","0 Years","70 Years",{"count":80,"type":20},40,[55],"The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed\u002F refractory B-lineage leukaemia\u002F lymphoma.",[84,28,85,86,87,88],"Lymphoblastic Leukemia","Lymphoblastic Leukemia, Acute Adult","B-cell Acute Lymphoblastic Leukemia","Large B-cell Lymphoma","CAR",[90,91,92,93],"CAR T-cell therapy","Relapse\u002FRefractory","B-ALL","B-Lineage Lymphoma","2023-03-07",{"date":96,"type":33},"2023-03-09",{"date":98,"type":33},"2022-03-15",{"date":100,"type":20},"2026-12",{"name":102,"class":103},"KK Women's and Children's Hospital","OTHER_GOV",2,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":41},"100442606","phase-1-cartall-chimeric-antigen-receptor-car-t-cell-therapy-for-relapsed-refractory-t-lineage-acute-lymphoblastic-leukaemia-100442606","NCT05043571","CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed\u002F Refractory T-Lineage Acute Lymphoblastic Leukaemia","Anti-CD7 Protein Expression Blocker (PEBL) Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed\u002F Refractory T-Lineage Acute Lymphoblastic Leukaemia (CARTALL)","Inclusion Criteria:\n\n* Diagnosis\u002F Disease define as:\n\n  1. Relapsed T-cell acute lymphoblastic leukaemia\u002F lymphoma as defined by:\n\n     Bone marrow disease = or \\> 0.01% by MRD as determined by flow cytometry\n\n     Or CNS disease as defined as \\> 5 WBCs\u002F uL in CSF with morphological evidence of blasts or biopsy proven recurrence in the eye or brain\n\n     Or Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites\n  2. Induction failure as defined by:\n\n     MRD = or \\> 1% by flow cytometry at the end of induction on day 33\n\n     Or Failure to achieve morphological remission defined as \\> 5% blasts after standard induction chemotherapy\n  3. Refractory disease as defined by:\n\n     MRD = or \\> 0.01% by flow cytometry or molecular methods during 2 or more timepoints after induction therapy\n* Minimum level of pulmonary reserve defined as Grade ≤ 1 dyspnoea and oxygen saturation (SpO2) of \\> 95% on room air\n* Left ventricular systolic function (LVSF) ≥ 28% confirmed by echocardiogram, or left ventricular ejection fraction (LVEF) ≥ 45% confirmed by echocardiogram within 3 months of screening\n* Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening\n* Normal Age-adjusted eGFR Creatinine Clearance within 3 months of screening\n* Alanine aminotransferase ≤ 5 times the upper limit of normal for age\n* Patients with \\> 99% CD7 expression on blast cells will be eligible for anti-CD7 PEBL-CAR-T cell infusion.\n\nExclusion Criteria:\n\n* Failure to meet any of the inclusion criteria\n* Patients who test positive on urine pregnancy testing and are pregnant or are lactating\n* Concomitant genetic syndromes associated with bone marrow failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other bone marrow failure syndrome with the exception of Down syndrome\n* Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease\n* Active or latent hepatitis B or hepatitis C infections within 8 weeks of screening, or any uncontrolled infection at screening\n* Positive Human Immunodeficiency Virus (HIV) test within 8 weeks of screening\n* Grade 2 to 4 acute graft-vs-host disease (GVHD) or extensive chronic GVHD\n* Received an investigational medicinal product within 30 days of screening\n* Central nervous system : Uncontrolled seizures or status epilepticus; increased intra-cranial pressure as evidenced by papilledema and CSF opening pressure \\> 20 cm water; decreased conscious state (any cause)","6 Months","65 Years",{"count":115,"type":20},20,[23],"The objective of this study is to assess the safety and efficacy of anti-CD7 CAR T-cells in patients with refractory or relapsed T-lineage acute lymphoblastic leukemia (T-ALL).",[119,84,85,28,88,120,121],"Lymphoblastic Leukemia, Acute, Childhood","CAR T-Cell-Related Encephalopathy Syndrome","Refractory Leukemia",[123,124,90],"T-ALL","CAR-T cell therapy","2021-09-07",{"date":127,"type":33},"2021-09-14",{"date":129,"type":20},"2021-09-08",{"date":131,"type":20},"2026-11-01",{"name":133,"class":40},"National University Hospital, Singapore",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":41},"100442231","phase-1-alacart-b-acute-leukemia-and-chimeric-antigen-receptor-t-cell-therapy-for-b-lymphoblastic-leukemia-100442231","NCT05038696","ALaCART-B: Acute Leukemia and Chimeric Antigen Receptor-T Cell Therapy for B-lymphoblastic Leukemia.","Chimeric-Antigen Receptor (CAR) T-Cell Therapy Using Multiple CARs and Cell Marker Profiling in High Risk and Relapsed\u002F Refractory B-Lineage Acute Lymphoblastic Leukaemia","ALaCART","Inclusion Criteria:\n\n* Fulfil the Diagnosis\u002F Disease define as:\n\n  1. Relapsed B-cell acute lymphoblastic leukaemia\u002F lymphoma as defined by:\n\n     Bone marrow disease = or \\> 0.01% by MRD as determined by flow cytometry Or CNS disease as defined as \\> 5 WBCs in CSF by morphology, or flow cytometric or molecular evidence of blasts or biopsy proven recurrence in the eye or brain.\n\n     Or Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites\n  2. Induction failure as defined by Day 33\u002F End of induction:\n\n     MRD ≥ 1% by flow cytometry on the Ma-Spore ALL 2020 protocol Or Failure to achieve morphological remission defined as \\> 5% blasts after standard induction chemotherapy\n  3. Refractory disease as defined by:\n\n     MRD ≥ 0.01% by flow cytometry or molecular methods during 2 or more timepoints after induction therapy\n  4. Any high risk features including :\n\n     BCR-ABL1, BCR-ABL1-like, - ABL1-r, PDGFRB-r, TCF3-HLF, MLL-r, hypodiploid ALL (\\\u003C 45 chromosomes), p53 pathogenic mutation as defined by RNA Seq or other molecular methods.\n  5. Patients who are unable to tolerate standard chemotherapy due to significant toxicity as well as other comorbidities\n* Minimum level of pulmonary reserve defined as grade ≤ 1 dyspnoea and oxygen saturation of \\> 95% on room air\n* Left ventricular systolic function ≥ 28% confirmed by echocardiogram, or left ventricular ejection fraction ≥ 45% confirmed by echocardiogram within 3 months of screening\n* Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening\n* Normal Age-adjusted eGFR Creatinine Clearance within 3 months of screening\n* Alanine aminotransferase ≤ 5 times the upper limit of normal for age\n* Patients with \\> 99.9% of CD19 expression on blast cells will be eligible for anti-CD19 CAR T-cell infusion.\n* Patients with partial or absent CD19 expression (\\\u003C 99.9%) on blast cells will be eligible to receive combinations of other CAR T-cells depending on the pattern of antigen expression.\n\nExclusion Criteria:\n\n* Failure to meet any of the inclusion criteria.\n* Patients who test positive on urine pregnancy testing and are pregnant or are lactating\n* Concomitant genetic syndromes associated with BM failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other BM failure syndrome with the exception of Down syndrome\n* Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease\n* Active or latent hepatitis B or active hepatitis C within 8 weeks of screening, or any uncontrolled infection at screening\n* Positive HIV test within 8 weeks of screening\n* Grade 2 to 4 acute graft-vs-host disease (GVHD) or extensive chronic GVHD\n* Received an investigational medicinal product within 30 days of screening\n* Persistent disease or relapse after other forms of CAR-T cell therapy.","80 Years",{"count":80,"type":20},[23],"The objective of this study is to assess the safety and efficacy of a immunophenotype-adapted approach using CAR T-cells in patients with high-risk, refractory or relapsed B-lineage acute lymphoblastic leukemia (B-ALL).",[119,84,85,28,88,120],[92,124,90],{"date":149,"type":33},"2021-09-09",{"date":151,"type":33},"2021-04-28",{"date":153,"type":20},"2026-08-01",{"name":133,"class":40}]