[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-effector-cell-associated-neurotoxicity-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-effector-cell-associated-neurotoxicity-syndrome":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,69,95,131],{"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":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100623990","assessing-dcog-short-for-neurotoxicity-in-car-t-100623990",false,"NCT07403812","Assessing DCog Short for Neurotoxicity in CAR-T","Assessing the Performance of \"DCog Short\", an iPad-Based Tool for Neurotoxicity Evaluation in CAR-T Cell Therapy Patients: A Pilot Study","Inclusion Criteria:\n\n* participants treated with CART-Cell therapy as described above and therefore at risk for treatment associated neurotoxicity.\n* Visual acuity of 20\u002F100 or better.\n\nExclusion Criteria:\n\n* patients \\\u003C 18 years old\n* pregnant women\n* prisoners\n* adults unable to consent,\n* participants unwilling to use iPad-based tools. Severe motor deficits that can prevent patients from using an iPad","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","The aim of this study is to determine the effectiveness of DCog Short, a self-reporting, iPad-based application tool, in assessing neurotoxicity in participants undergoing CAR-T cell therapy.",[26,27,28,29],"Neurotoxicity","Neurotoxicity Syndromes","Hematologic Malignancy","Immune Effector Cell Associated Neurotoxicity Syndrome",[26,31,28,29],"Neurotoxicity Syndrome","NOT_YET_RECRUITING","2026-02-04",{"date":35,"type":36},"2026-02-11","ACTUAL",{"date":38,"type":20},"2026-07",{"date":40,"type":20},"2027-08-31",{"name":42,"class":43},"Beth Israel Deaconess Medical Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":44},"100622934","multimodal-telerehabilitation-in-patients-undergoing-car-t-cell-immunotherapy-100622934","NCT07390071","Multimodal Telerehabilitation in Patients Undergoing CAR-T Cell Immunotherapy","Inclusion Criteria:\n\n* age \\>21\n* confirmed diagnosis of lymphoma or myeloma\n* commercial FDA-approved CAR-T delivery planned for ≥4 weeks following enrollment\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Access to a working telephone line in their home or a cell phone.\n\nExclusion Criteria:\n\n* have unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers, painful or unstable bony metastases, or recent skeletal fractures;\n* are engaged in a regular exercise rehabilitation program;\n* have relocation plans within next 6 months;\n* participate in another clinical trial.","21 Years",{"count":19,"type":20},[23],"The proposed multimodal telerehabilitation model allows a rehabilitation therapy team to set up individualized rehabilitation plans using a web-based care management portal and monitor patient progress online. Patients at home follow a safe and effective personalized exercise and nutrition plan guided by interactive touch-screen technology combined with behavioral counseling, social support, and interactive education and empowerment. The design of the telerehabilitation system is based on the cloud-based Internet-of-Things architecture allowing real-time monitoring of cardiovascular parameters and exercise performance. The patient's level of exertion during exercise is automatically identified by a validated AI-driven algorithm supporting exercise safety and efficacy. The ultimate goal of this pilot feasibility project is to establish the extent of the impact of the proposed patient-centered cancer telerehabilitation model on disease-specific quality of life, and functional and symptom outcomes and to obtain sufficient evidence for a definitive randomized clinical trial evaluating this approach in a multi-center study.",[56,57,58,29],"Lymphoma","Myeloma","Cytokine Release Syndrome","RECRUITING","2026-01-28",{"date":62,"type":36},"2026-02-05",{"date":64,"type":36},"2025-09-01",{"date":66,"type":20},"2029-01",{"name":68,"class":43},"University of Utah",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":44},"100570350","phase-4-temporal-characterization-of-extracellular-vesicles-during-cellular-therapy-using-car-t-cells-and-during-the-occurrence-of-immune-effector-cell-associated-neurotoxicity-syndrome-100570350","NCT06706102","Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome","VESICANS","Inclusion Criteria:\n\n* Patient aged over 18,\n* Patient for whom CAR-T treatment is indicated,\n* Patient affiliated to a social security system\n* Patient who give his consent to participate in the study.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman,\n* Patient unable to understand informed consent,\n* Patient under legal protection.",{"count":77,"type":20},60,[79],"PHASE4","Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) is a common and serious neurological complication associated with the use of CAR-T cells. The mechanisms involved are still poorly understood but studies suggest that inflammation during treatment leads to an increase in the permeability of the barrier between the brain and the blood vessels and the emission of extracellular vesicles (EVs) circulating between the brain and the blood vessels. EVs are biological particles that play an important role in cellular communication and the modulation of several physiological processes. The VESICANS study aims to characterize the EVs released before and during CAR-T cells treatment and upon the occurrence of ICANS, using flow cytometry, electron microscopy, Nanoparticle Tracking Analysis associated with MRI assessment of the barrier between the brain and blood. This study will ultimately contribute to facilitating the prevention and treatment of this toxicity which affects the prognosis of patients.",[29],[83,84,85],"CAR-T Cell","ICANS","EVs","2025-07-04",{"date":88,"type":36},"2025-07-09",{"date":90,"type":36},"2025-07-02",{"date":92,"type":20},"2027-11",{"name":94,"class":43},"Centre Hospitalier Universitaire de Saint Etienne",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":44},"100570128","phase-1-pre-emptive-anakinra-for-cytokine-event-reduction-100570128","NCT06703216","Pre-emptive Anakinra for Cytokine Event Reduction","Pilot Study of Pre-emptive Anakinra for the Prevention of Severe Cytokine Release Syndrome in Children and Young Adults With B-Acute Lymphoblastic Leukemia Receiving Chimeric Antigen Receptor (CAR) T Cells","PACER","• Patient consent and parental assent will be obtained.\n\nNOTE: Signed consent form must be obtained prior to any study procedures. Labs, marrows or other procedures obtained during routine clinical care maybe used for eligibility if obtained within the protocol required windows.\n\n* Patients or their parents\u002Flegally authorized representatives (LARs) must have the ability to understand and the willingness to sign a written informed consent document.\n* The effects of Anakinra on the developing human fetus are largely unknown. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 90 days following completion of Anakinra therapy. Should a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of informed consent, for the duration of study participation, and 90 days after completion of administration.\n\nNote: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy\n* Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n* POCBP must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)\n* Patients who are between the age of 1 to 26 years\n* Relapsed or refractory B-acute lymphoblastic leukemia\n\n  * 2nd or greater marrow relapse OR\n  * Central nervous system (CNS) relapse OR\n  * Any relapse after allogeneic hematopoietic stem cell transplant (HSCT) OR\n  * Refractory disease defined by not achieving an minimal residual disease (MRD)-negative complete remission (CR) after ≥ 2 chemotherapy cycles (1 cycle for relapsed patients) OR\n  * Ineligible for allogeneic HSCT because of:\n\n    * Comorbid disease\n    * Other contraindications to allogeneic HSCT conditioning\n    * No suitable donor\n    * Prior HSCT\n    * Declines HSCT as the therapeutic option after documented discussion, with expected outcomes, about the role of HSCT with a HSCT physician\n  * Documentation of CD19+ tumor expression in the bone marrow, peripheral blood, cerebrospinal fluid (CSF), or tumor tissue by flow cytometry at relapse, or a recent sample in the case of refractory disease. If the patient has received CD19-directed Pre-emptive anakinra for severe CRS prevention therapy, the flow cytometry should be obtained after this therapy to show CD19 expression.\n* Adequate organ function defined as:\n\n  * Alanine aminotransferase (ALT) \\\u003C 500 U\u002FL\n  * Bilirubin ≤2.0 mg\u002FdL\n  * Minimum pulmonary reserve defined as ≤Grade 1 dyspnea, pulse oximetry \\>92% on room air; diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% (corrected for anemia) if pulmonary function tests (PFTs) are clinically appropriate as determined by the treating investigator.\n  * Left ventricular shortening fraction ≥ 28% or ejection fraction ≥40% confirmed by echocardiography (ECHO), or adequate ventricular function documented by imaging or a cardiologist.\n  * Serum creatinine below the values in the below table, based on age\u002Fsex assigned at birth: Maximum Serum Creatinine (mg\u002FdL) Age (years) Male Female 1 to \\\u003C2 0.6 0.6 2 to \\\u003C6 0.8 0.8 6 to \\\u003C10 1.0 1.0 10 to \\\u003C13 1.2 1.2 13 to \\\u003C16 1.5 1.4 ≥16 1.7 1.4\n* Bone marrow disease burden of ≥5% or peripheral blasts within 2 weeks of the start of lymphodepleting chemotherapy\n* Receiving commercially available tisagenlecleucel","1 Year","25 Years",{"count":106,"type":20},24,[108,109],"PHASE1","PHASE2","Objectives: The primary objective of this study will be to evaluate the impact of pre-emptive use of anakinra on the rate of severe cytokine release syndrome (CRS) following CD19-directed chimeric antigen receptor (CAR) T-cell therapy for B-acute lymphoblastic leukemia (B-ALL) in children and young adults.\n\nPatient Population: Children and young adults \\\u003C25 years of age undergoing CAR T-cell therapy for B-ALL with bone marrow disease burden of ≥5% involvement or detectable peripheral blasts within 2 weeks of the initiation of lymphodepleting chemotherapy.\n\nStudy Design: This is a pilot single arm study. The investigators will inquire into the efficacy and safety of using anakinra pre-emptively to reduce the rate of severe CRS in patients with \\>\u002F=5% bone marrow blasts or lymphoblasts in the peripheral blood.\n\nTreatment Plan:\n\nThis is a single arm unblinded study in which patients will receive anakinra, 2.5 mg\u002Fkg (max 100mg), IV every 12 hours starting at the onset of persistent fever (fever \\>38.5⁰ C x 2 occurrences separated by at least 4 hours in a 24 hour period). If there is persistence or progression of CRS, anakinra frequency will be increased to 2.5mg\u002Fkg IV (max 100mg), every 6 hours. Anakinra will be continued until 48 hours after resolution of CRS and ICANS, and at least 7 days post-CAR T infusion. If dose and frequency of anakinra is increased, the increased dose of anakinra will be continued until 48 hours after resolution of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) and at least 7 days post-CAR T infusion. For CRS worsening beyond dose escalation of anakinra, CRS will be managed as per standard of care management. Participants will be followed for 12 months following enrollment in the study and disease evaluations will be performed as per routine clinical care following CAR T-cell therapy.",[112,113,58,29,114],"B-Acute Lymphoblastic Leukemia","CAR-T Cell Therapy","Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome",[116,58,117,118,119,120,121,29],"Anakinra","CAR-T Therapy","Pediatric","B-acute lymphoblastic leukemia","Prophylaxis","Inflammatory Toxicity","2025-06-12",{"date":124,"type":36},"2025-06-15",{"date":126,"type":20},"2025-08",{"date":128,"type":20},"2030-02-28",{"name":130,"class":43},"Ann & Robert H Lurie Children's Hospital of Chicago",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":44},"100488667","biomarker-and-imaging-package-study-in-immune-effector-cell-associated-neurotoxicity-syndrome-100488667","NCT05643092","Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome","Inclusion Criteria:\n\n* Subjects must be ≥ 18 years of age at signing of informed consent.\n* Subjects are scheduled to receive CAR T-cell treatment.\n\nExclusion Criteria:\n\n* Refusal to sign the informed consent\n* Subjects having previously been treated with CAR-T therapy.\n* Subjects with clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleeding\n* Subjects presenting primary CNS lymphoma\n* Pacemaker or other implanted electrical device incompatible with the MR environment\n* Subjects with a neurodegenerative disease (PD, AD)\n* Subjects with a previous or evolving neurological pathology\n* Pregnant or breastfeeding women","80 Years",{"count":139,"type":20},50,"OBSERVATIONAL","CAR T-cell therapy is a promising innovative therapy for hematological malignancies. Immune effectors cells-associated neurotoxicity syndrome (ICANS) is a significant complication of CAR therapy. The goal of this study is to understand what brain mechanisms become disrupted when patients experience ICANS. The study will test the hypothesis that cerebrospinal fluid catecholamines and multimodal magnetic resonance imaging are affected in this disorder.\n\nTo test this hypothesis, the study will measure cerebrospinal fluid catecholamines in ICANS patients and evaluate brain magnetic resonance imaging for these participants. This study may contribute to knowledge about brain biomarkers and imaging of ICANS, which will greatly aid in ICANS detection and prevention.",[29],"2023-03-05",{"date":145,"type":36},"2023-03-07",{"date":147,"type":36},"2023-03-06",{"date":149,"type":20},"2027-12",{"name":151,"class":43},"zhang shoulong"]