[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-lymphoblastic-leukemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100527195","phase-2-study-of-kte-x19-in-minimal-residual-disease-mrd-positive-b-cell-acute-lymphoblastic-leukemia-b-all-100527195",false,"NCT06144606","Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)","Phase 2 Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)","Inclusion Criteria:\n\n* Must be an adult 18 years of age or older.\n* Pathologically confirmed CD19 positive B-cell acute lymphoblastic leukemia.\n* Treatment and full recovery from induction chemotherapy, with following exceptions:\n\nA. Vincristine associated grade 1 peripheral neuropathy B. Steroid\u002Fasparaginase associated diabetes and\u002For hypertension C. Inotuzumab\u002Fchemotherapy associated cytopenias\n\n* Patients must be in a complete remission with Minimal Residual Disease (MRD) following an induction regimen. MRD is defined herein as a bone marrow biopsy with fewer than 5% lymphoblasts. Complete remission implies the resolution of any extramedullary and\u002For Central Nervous Syndrome (CNS)-2-3\u002Fparenchymal disease.\n* Be willing and able to provide written informed consent\u002Fassent for the trial.\n* Able to adhere to the study visit schedule and other protocol requirements.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Adequate renal, hepatic, pulmonary, cardiac function.\n* Adequate hematopoietic reserve.\n* Females of childbearing potential (FCBP) must have a negative serum pregnancy test at screening. A FCBP is considered when a sexually mature female:\n\n  1\\) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months.\n* Subjects of both genders of child-bearing potential must be willing to practice birth control from the time of consent through 6 months after the completion of KTE-X19 infusion.\n\nExclusion Criteria:\n\n* Diagnosis of L3 type Burkitt's lymphoma, Mixed-Lineage Leukemia (MLL) rearranged leukemia, biphenotypic leukemia, mixed phenotype acute leukemia, blast phase of chronic myeloid leukemia, or stem-cell leukemia.\n* Any active infection requiring systemic therapy, including HIV, Hepatitis B, and\u002For Hepatitis C.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator (including but not limited to unstable angina, pre-existing liver disease, recurrent pancreatitis, uncontrolled diabetes, hypertriglyceridemia, pulmonary hypertension, or severe Congestive Heart Failure (CHF).\n* Recurrent thrombosis, or non-central venous catheter associated thrombosis within 3 months prior to enrollment.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.\n* History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome (PRES), or cerebral edema.\n* Active CNS\u002Fleptomeningeal leukemia.\n* Severe comorbid conditions for which life expectancy would be \\\u003C6 months.\n* Patients with active (uncontrolled, metastatic) second malignancies are excluded.\n* History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome.\n* Primary immunodeficiency or history of autoimmune disease (Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.\n* Corticosteroid therapy at a pharmacologic dose (\\> 5 mg\u002Fday of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs must be avoided for 7 days prior to enrollment.\n* Presence of any indwelling line or drain (percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural\u002Fperitoneal\u002Fpericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted.\n* Live vaccine ≤ 4 weeks prior to enrollment.\n* Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy",[26,27],"B-Cell Lymphoblastic Leukemia","Acute Lymphoblastic Leukemia","RECRUITING","2026-03-30",{"date":31,"type":32},"2026-03-31","ACTUAL",{"date":34,"type":32},"2023-12-26",{"date":36,"type":20},"2028-11-15",{"name":38,"class":39},"H. Lee Moffitt Cancer Center and Research Institute","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":63,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100625415","a-multi-site-study-to-evaluate-the-persistence-of-protective-immunity-to-routine-childhood-vaccinations-in-participants-with-b-allly-who-have-received-blinatumomab-100625415","NCT07422337","A Multi-site Study to Evaluate the Persistence of Protective Immunity to Routine Childhood Vaccinations in Participants With B-ALL\u002FLy Who Have Received Blinatumomab","Blinatumomab's Outcome On Serologic Titers and Efficacy of Revaccination","BOOSTER","Inclusion Criteria:\n\n* Diagnosis of B-lineage acute lymphoblastic leukemia\u002Flymphoma\n* ≥1 year old and up to 21 years old at diagnosis\n* Informed consent provided, and if applicable, child assent provided\n* Must have received all vaccinations routinely administered during first year of life\n\nExclusion Criteria:\n\n* Relapsed\u002Frefractory disease at any time\n* Received or will require a bone marrow transplant and\u002For cellular therapy\n* Pregnancy","1 Year","23 Years",{"count":52,"type":20},300,"OBSERVATIONAL","The goal of this observational study is to establish a clear vaccination protocol for pediatric patients (less than 21 years old) who have received treatment for B-cell Acute Lymphoblastic Leukemia\u002FLymphoma. The main study aims are:\n\n* Evaluate the persistence of protective immunity to routine childhood vaccinations in participants with B-ALL\u002FLy who have received blinatumomab.\n* To determine whether revaccination in participants with non-protective titers leads to restored humoral immunity.\n\nResearchers will compare results from participants who have received immunotherapy to those who have not received immunotherapy to see if immunotherapy versus other chemotherapeutic drugs adversely affect the protective immunity acquired through vaccination.",[56,57,26,58,59,60,61,62],"B-Cell ALL","B-Cell Acute Lymphoblastic Leukaemia","B-Cell Lymphoblastic Leukemia\u002FLymphoma","B-cell Acute Lymphoblastic Leukemia (B-ALL)","B-cell Acute Lymphoblastic Leukemia","B-cell Childhood Acute Lymphoblastic Leukemia","B-cell Leukemia",[64,65,66,67],"vaccines","cancer","blinatumomab","immunotherapy","2026-02-23",{"date":70,"type":32},"2026-02-25",{"date":72,"type":32},"2026-01-13",{"date":74,"type":20},"2029-01",{"name":76,"class":39},"Arkansas Children's Hospital Research Institute",2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":17,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100562765","phase-2-efficacy-study-of-blinatumomab-clean-up-early-residual-disease-for-newly-diagnosed-pediatric-b-lymphoblastic-leukemia-100562765","NCT06607419","Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia","BBClean","Inclusion Criteria:\n\n* Age older than 1 month to younger than 18 years.\n* Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.\n* Immunophenotyping: acute B-lymphoblastic leukemia;\n* Meet one of the following situations:\n\nA. Provisional low-risk: D19MRD ≥ 0.1%; B. Provisional intermediate-risk: D19MRD ≥ 0.01%;\n\n* Subjects in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the Ethics Committee\n\nExclusion Criteria:\n\n* sIgM+;\n* ALL evolved from chronic myeloid leukemia (CML);\n* Down's syndrome, or major congenital or hereditary disease with organ dysfunction;\n* Other secondary leukemias;\n* CNS involvement;\n* History of epilepsy; or convulsions within the last month;\n* Known underlying congenital immunodeficiency or metabolic disease;\n* Congenital heart disease with cardiac insufficiency;\n* Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \\> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression);\n* Initial diagnosis of high risk;\n* D46MRD ≥1%.","1 Month",{"count":87,"type":20},90,[23,89],"PHASE3","The goal of this clinical trial is to evaluate the efficacy of Blinatumomab in pediatric patient with newly diagnosed acute B-Lymphoblastic leukemia with poor response to early chemotherapy, i.e. day 19 MRD ≥ 0.1% (low-risk) or day 19 MRD ≥ 0.01% (intermediate-risk). The main question is:\n\n• If the flow cytometric MRD negative (\\\u003C0.01%) rate and the NGS- MRD negative (\\\u003C0.0001%) rate at the end of induction for patients received Blinatumomab will be superior to historical control (D46MRD in the CCCG-ALL2020 protocol).\n\nParticipants will:\n\n* Take 14 days full dose Blinatumomab;\n* With bone marrow evaluated before and after Blinatumomab treatment.",[26],[93,26,94],"Children","Blinatumomab","2024-09-20",{"date":97,"type":32},"2024-09-23",{"date":99,"type":32},"2024-05-21",{"date":101,"type":20},"2030-05-31",{"name":103,"class":39},"Shanghai Jiao Tong University School of Medicine",4]