[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-acute-lymphoblastic-leukaemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-acute-lymphoblastic-leukaemia":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,39,63,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100601948","blinatumomab-consolidation-in-real-world-100601948",false,"NCT07117136","Blinatumomab Consolidation in Real World","Real World Outcomes of Blinatumomab Consolidation in Patients With B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* 1\\) aged 18 years or older 2) diagnosed with B-ALL on or after December 1st 2023 3) Not received blinatumomab in an interventional clinical trial setting 4) Willing and able to give informed consent (or retrospective data for deceased patients\n\nExclusion Criteria:\n\n* N\u002FA",true,"ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","This will be a multi-center registry for patients with B-ALL. Patient data will be collected both retrospectively and prospectively. The data forms and surveys will be built and managed through REDCap, a secure web application managed by the Clinical \\& Translational Science Institute.",[25],"B-Cell Acute Lymphoblastic Leukaemia","RECRUITING","2026-06-16",{"date":29,"type":30},"2026-06-18","ACTUAL",{"date":32,"type":30},"2025-08-28",{"date":34,"type":21},"2029-05-14",{"name":36,"class":37},"Medical College of Wisconsin","OTHER",2,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100639269","car-t-treatment-in-pediatric-and-adult-acute-lymphoblastic-leukemia-100639269","NCT07623655","CAR-T Treatment in Pediatric and Adult Acute Lymphoblastic Leukemia","Observational Retrospective and Prospective Multicentric Study on CAR-T Cell for the Treatment of Pediatric and Adult B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Diagnosis of ALL R\u002FR CD19+\n2. Patients are pediatric (all patients up to the age of 18) adult (all comers older than 18)\n3. Prescribed treatment with Tisagenlecleucel or Brexucabtagene autoleucel as per approved AIFA criteria, or obecabtagene autoleucel - as well as other products - when available\n4. Provided consent (or did not opposed) for collection and use of patient data per local regulations\n\nExclusion Criteria:\n\nNone\n\n\\-",{"count":47,"type":21},107,"The goal of this observational study is to evaluate the efficacy of the treatment with approved CAR-T cells in Italy in pediatric and adult patients with acute B-cell lymphoblastic leukemia. The main question it aims to answer is:\n\nwhich is the overall response rate in pediatric and adult patients with acute B-cell lymphoblastic leukemia treated with approved CAR-T cells?\n\nData will be extracted from patients medical records.",[50,25],"Acute Lymphoblastic Leukemia",[52],"CAR-T cell, pediatric, adult","NOT_YET_RECRUITING","2026-05-29",{"date":56,"type":30},"2026-06-03",{"date":58,"type":21},"2026-09-01",{"date":60,"type":21},"2029-12-30",{"name":62,"class":37},"Gruppo Italiano Malattie EMatologiche dell'Adulto",{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":17,"minAge":70,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100629596","phase-3-international-study-for-treatment-of-childhood-relapsed-precursor-b-cell-all-2020-intreall-bcp-2020-100629596","NCT07476729","International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020)","International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group","Inclusion Criteria:\n\nFor all study questions:\n\n* Confirmed diagnosis of 1st relapsed B-cell precursor ALL\n* Patients ≥ 1 year and less than 18 years of age at diagnosis of primary ALL and less than 21 years of age at date of inclusion into the study\n* Patient enrolled in a participating center\n* Written informed consent (IC)\n* Start of treatment falling into the study period\n* No participation in other clinical trials 30 days prior to study enrolment that interfere with this protocol, except trials for primary ALL\n\nSpecific for SR induction randomization:\n\n* Meeting SR criteria\n* BM involvement (≥ 5% or ≥ 1% leukemic blasts confirmed by 2 quantitative methods)\n* CD22 positive ALL (\\>80% confirmed by flow-cytometry)\n* No previous history of veno-occlusive disease (VOD)\u002F sinusoidal obstruction syndrome (SOS)\n\nSpecific for SR MRD poor response consolidation:\n\n* Meeting SR criteria with bone marrow involvement at relapse diagnosis\n* M1\u002FCR2 and MRD ≥ 10-4 after induction\n* CD19 positive ALL at relapse (\\>10%)\n\nSpecific for SR MRD good response consolidation:\n\n* Meeting SR criteria with bone marrow involvement at relapse diagnosis\n* M1\u002FCR2 and MRD \\\u003C 10-4 after induction\n* CD19 positive ALL at relapse (\\>10%) Specific for HR consolidation arm\n* Meeting HR or VHR (in case of no possibility to be treated with CAR T cells) criteria\n* M1\u002FCR2 after induction therapy\n* CD19 positive ALL at relapse (\\>10%)\n\nSpecific for IEM arm:\n\n* Histology or cytology proven extramedullary relapse\n* No bone marrow involvement (M1 at relapse diagnosis) and bone marrow MRD \\\u003C1%\n* CD19 positive ALL at relapse (\\>10%)\n\nExclusion Criteria:\n\n* Known hypersensitivity to the active substances or excipients of the IMP's or the SOC drugs, except to PEG-asparaginase which can be replaced by Erwinase\n* Left ventricular ejection fraction (LVEF) \\\u003C 50% or fractional shortening \\\u003C 25%, and\u002For current or prior treatment for cardiomyopathy and\u002For history of clinically significant arrhythmias\n* Pregnancy or positive pregnancy test in female patients (urine sample positive for β-HCG \\> 10 U\u002Fl) at screening or within 7 days prior to the initiation of study treatment\n* Sexually active adolescents and adults not willing to use highly effective contraceptive method (pearl index \\\u003C1) until 12 months after end of anti-leukemic therapy\n* Women not willing to refrain from breast feeding until 12 months after end of anti-leukemic therapy\n* Relapse post allogeneic HSCT\n* Relapse post chimeric antigen receptor T-cell (CAR-T) therapy\n* The whole protocol or essential parts are declined either by patient himself\u002Fherself or the respective legal guardian\n* Objection to the study participation by a minor patient\n* Patients in a dependent or subordinate relationship to the investigator or site staff (e.g. employees, relatives, or students)\n* No consent is given for saving and propagation of pseudonymized medical data for study reasons\n* Patients with any concurrent medical condition, laboratory abnormality, concomitant treatment, or comorbidity that, in the investigator's clinical judgment would\n\n  * compromise the patient's ability to safely receive or tolerate inotuzumab ozogamicin and\u002For blinatumomab\n  * significantly interfere with assessment of treatment efficacy or safety\n  * make it unlikely that the patient would derive clinical benefit from protocol therapy\n  * preclude adherence to study procedures or follow-up requirements\n* Subjects unwilling or unable to comply with the study procedures\n* Subjects who are legally detained in an official institute\n\nSpecific for SR induction randomization:\n\n* Prior confirmed severe (grade 3 or 4) or ongoing VOD\u002FSOS\n* Serious ongoing hepatic disease (e.g., cirrhosis, active hepatitis) not related to the current ALL relapse or current diagnostic\u002Ftherapeutic measures\n* ALT \\> 2,5 x ULN (at relapse diagnosis before start of cytoreduction) and\u002For bilirubin \\> 1.5 x ULN\n* Patients with intolerance to PEG-asparagniase and also to Erwinase are stratified to the inotuzumab arm\n* Patients with insufficient expression of CD22 (\\\u003C 80%) on leukemic blasts, they are assigned to the control chemotherapy arrm\n\nSpecific for blinatumomab treatment:\n\n* Clinically relevant CNS pathology requiring treatment (eg, unstable epilepsy)\n* Evidence of current CNS (CNS 2, CNS 3) involvement by ALL. Subjects with CNS relapse at the time of relapse are eligible if CNS is successfully treated prior to enrollment\n\nAllowed systemic diseases and concomitant medication\n\n* Patients with Down Syndrome (DS) can be included as separate and descriptive population, not joining the study questions. Those with BM involvement receive inotuzumab ozogamicin for induction without randomization. HR patients and SR patients with MRD poor response will be allocated to allo-HSCT indication, or in case CD19 directed CAR-T-cell therapy off-protocol as individualized treatment approach. Patients with MRD good response will get the SR consolidation and maintenance therapy. Those with IEM profile will be treated according to the IEM stratum. Patients not expressing sufficiently CD22 and\u002For CD19 will receive the respective chemotherapy strategy.\n* Patients with BCR::ABL positive (Ph+) or BCR::ABL like (Ph-like) BCP ALL with TKI treatment option can be included as separate and descriptive population, not joining the study questions. Those with BM involvement receive inotuzumab ozogamicin plus TKI (investigators choice) without randomization for induction followed by HC1 and blinatumomab plus TKI followed by allo-HSCT. Those with IEM profile will be treated according to the IEM stratum plus TKI. Patients not expressing sufficiently CD22 and\u002For CD19 will receive the respective chemotherapy strategy.\n* Patients with systemic diseases such as cystic fibrosis or diabetes may be eligible for enrolment in this study only if they presumably will tolerate the protocol treatment and primary dose reductions would not be necessary.\n* Any kind of concomitant medication given due to medical reasons is allowed. Incompatibilities and drug interactions with the study medications are listed in the appendix. In case of expected adverse interactions, concomitant therapies should be changed to alternative less problematic agents if possible\n\nProhibited medication\n\n* Antileukemic therapy other than scheduled in the protocol (except cytoreductive pre-phase with dexamethasone)\n* Investigational drugs other than scheduled in the protocol\n* Attenuated live vaccines which are strictly prohibited during and until 6 months after end of chemotherapy or 18 months after allo-HSCT","1 Year",{"count":72,"type":21},750,"INTERVENTIONAL",[75],"PHASE3","The IntReALL BCP 2020 study aims to review recent developments and findings regarding chemoimmunotherapy with inotuzumab and immunotherapy with blinatumomab and to increase the use of promising new immunotherapeutic drugs as replacements for toxic SOC chemotherapy elements.\n\nThe IntReALL BCP 2020 study has the potential to improve CR and EFS rates for all SR and HR groups, as well as for patients with IEM recurrence, by replacing toxic chemotherapy with targeted, less toxic immunotherapy strategies, and could establish these new approaches as SOC for children with relapsed BCP ALL in the future.",[25],[79],"Lymphoblastic","2026-03-12",{"date":82,"type":30},"2026-03-17",{"date":84,"type":21},"2026-04-01",{"date":86,"type":21},"2033-03-31",{"name":88,"class":37},"Charite University, Berlin, Germany",20,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":70,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":101,"conditions":102,"keywords":110,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":38},"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","23 Years",{"count":100,"type":21},300,"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.",[103,25,104,105,106,107,108,109],"B-Cell ALL","B-Cell Lymphoblastic Leukemia","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",[111,112,113,114],"vaccines","cancer","blinatumomab","immunotherapy","2026-02-23",{"date":117,"type":30},"2026-02-25",{"date":119,"type":30},"2026-01-13",{"date":121,"type":21},"2029-01",{"name":123,"class":37},"Arkansas Children's Hospital Research Institute"]