[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chimeric-antigen-receptor-t-cell-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chimeric-antigen-receptor-t-cell-therapy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100651003","immunoglobulin-replacement-therapy-igrt-versus-antibiotic-prophylaxis-pa-in-patients-treated-by-cd19-targeted-chimeric-antigen-receptor-cart-cells-for-a-b-cell-acute-lymphoblastic-leukemia-or-a-b-cell-lymphoma-100651003",false,"NCT07754682","Immunoglobulin Replacement Therapy (IgRT) Versus Antibiotic Prophylaxis (PA) in Patients Treated by CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for a B Cell Acute Lymphoblastic Leukemia or a B Cell Lymphoma","A Multicentric Phase III Randomized Clinical Trial Open-label, Comparing Immunoglobulin Replacement Therapy (IgRT) and Antibiotic Prophylaxis (AP) in Patients Treated by CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for a B Cell Acute Lymphoblastic Leukemia or a B Cell Lymphoma","PREV-CART","Inclusion Criteria:\n\n1. Age 16-80 years at inclusion\n2. B-cell acute lymphoblastic leukemia or a B-cell lymphoma\n3. With gamma globulins \\\u003C4g\u002FL at the time of screening\n4. Receiving CD19-targeted autologous CAR-T cells (with AMM in their indication)\n5. Patients with childbearing potential\\* should have reliable contraception for the all duration of the study and another 12 months after CAR-T infusion.\n6. Contraceptive measures for concerned patients\n7. Informed consent signed by patient or legal representatives\n\nExclusion Criteria:\n\n1. Any medical history of intolerance to intravenous immunoglobulin\n2. With renal failure calculated glomerular filtrate rate \\\u003C30 mL \u002F min;\n3. With hepatic failure or hepatitis or bilirubin\\> 3 times the upper limit of normal, Serum ALT\u002FAST \\>=5N\n4. With existing serious acute infection\n5. Contraindication to immunoglobulin or to prophylactic antibiotherapy administered in this clinical trial\n6. No health insurance coverage\n7. Females who are pregnant or breastfeeding\n8. Participation in another interventional study or being","ALL","16 Years","80 Years",{"count":21,"type":22},228,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","B cell (CD19) targeted chimeric antigen receptor modified T Cells (CAR-T) has transformed treatment of relapsed\u002Frefractory B-cell acute lymphoblastic leukemia (B-ALL) or B-cell lymphoma (BCL).\n\nBecause patients receiving CAR-T often present uncontrolled disease and have undergone several lines of treatment, they may be deeply immuno-depressed and prone to infections. Hypogammaglobulinemia were reported in 74% of patients preCAR-T cells infusion (Hill JA, et al. Blood Rev. 2019 Nov). CART cells also results in depletion of normal CD19+ B cells and hypogammaglobulinemia as an on-target, off tumor toxicity.\n\nBecause CAR-T cells can persist for years, patients are exposed to infectious complications secondary to long-term Bcell aplasia and severe hypogammaglobulinemia (\\\u003C4g\u002Fl). Data from patients who received rituximab (CD20-specific monoclonal antibody) show that patients with severe hypogammaglobulinemia experienced recurrent bronchitis, sinusitis, pneumonia, and rarely, enteroviral meningoencephalitis. In patients receiving CAR T-cells, infection density is 0.55-0.67 infections\u002F100 days3,5 at risk after the first month with a majority of respiratory and ENT (earsnose-throat) infections. To prevent infections, anti-bacterial prophylaxis (AP) based on local guidelines is often used in patients treated by CAR-T cells, with the risk of subsequent resistance. Otherwise, intravenous immunoglobulin replacement therapy (IgRT) is authorized by the French authorities for patients with secondary antibody deficiencies who developed severe or recurrent infections after appropriate antimicrobial therapy, if IgG levels \\\u003C4g\u002Fl. However, although IgRT as primary prophylaxis (PP) have no approval, they are used as PP after CAR T-cells by many centers, with no data supporting such a strategy. The benefit of IgRT over AP as a primary prophylaxis in the setting of CD19 CAR-T cells therapy should be demonstrated given its burden for patients and care, as well as its cost and the risk of Ig shortage. Therefore, this multi-centric prospective randomized openlabel study aims to assess the benefits of IgRT versus AP as PP in patients with secondary antibody deficiencies.",[28,29,30,31,32],"Chimeric Antigen Receptor T-cell Therapy","B Cell Acute Lymphoblastic Leukemia (B-ALL)","B Cell Lymphoma","Antibiotic Prophylaxis","Immunoglobulin Therapy","NOT_YET_RECRUITING","2026-08-04",{"date":36,"type":37},"2026-08-10","ACTUAL",{"date":39,"type":22},"2026-09-01",{"date":41,"type":22},"2029-09-01",{"name":43,"class":44},"Assistance Publique - Hôpitaux de Paris","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100584496","study-of-the-association-between-fatigue-experienced-by-patients-and-the-specific-side-effects-of-cart-cells-during-the-first-month-after-administration-for-non-hodgkins-lymphoma-100584496","NCT06890091","Study of the Association Between Fatigue Experienced by Patients and the Specific Side Effects of CART Cells, During the First Month After Administration for Non-Hodgkin's Lymphoma","Etude de l'Association Entre la Fatigue Ressentie Par Les Patients et Les Effets Secondaires spécifiques Des CART Cells, au Cours du Premier Mois après l'Administration Pour un Lymphome Non Hodgkinien","CAR-TIGUE","Inclusion Criteria:\n\n* Adult (age\\> 18year old)\n* Person hospitalised for treatment with CAR-T Cells for non-Hodgkin's lymphoma.\n* Person able to understand and read the French language.\n\nExclusion Criteria:\n\n* Patient under legal protection\n* Opposition to research","18 Years",{"count":55,"type":22},100,"OBSERVATIONAL","The incidence of cancer in 2023 is estimated at 433136 cases, according to INCa. Haemopathies account for 12% of these new cases of cancer cases of cancer, and around two-thirds are lymphoid haemopathies, in particular lymphomas. There are many treatments available for lymphoma. However, the arrival in France in 2018 of immunotherapy treatments such as CAR-T Cells have changed the paradigm of treatment options for certain non-Hodgkin's lymphomas. In these treatments can have both short-term and long-term adverse effects and long-term adverse effects. During hospitalisation for the administration of CAR-T Cells, acute side effects include CRS and ICANS. There is also another complication very specific to this treatment that has been observed in patients: cytopenias. This is despite the fact that one of the symptoms frequently mentioned and felt by patients during the first month after month after treatment is fatigue. Despite numerous studies on the prevalence of fatigue, healthcare professionals often underestimate this symptom. Nurses, and in particular the advanced practice nurse have a crucial role to play in assessing fatigue. The EORTC scale QLQ-FA12 is a multidimensional scale which assesses the physical emotional and cognitive dimensions of fatigue. The theory of symptom management, which was developed in 1994 by the California College of Nursing in San Francisco, is a relevant framework for understanding fatigue in patients. This theory places the patient's experience at the centre of care. This holistic approach provides a detailed framework for understanding this symptom. \"According to the theoretical model, measuring the symptom is an important step and characterising it is an essential element in better targeting the actions to be taken\". Although CAR-T Cell therapy is innovative and allows long-term remissions, it is important to evaluate and understand how patients live with this treatment. To our knowledge, few studies have been carried out on quality of life, particularly regarding fatigue, following the first month of CAR-T Cell administration. The research question we will address in this study is: \"Is there an association between the side effects of CAR-T Cell treatment and the state of fatigue in patients receiving this treatment for non-Hodgkin's lymphoma during the first month?\"",[59,60,28,61],"Fatigue Symptom","Lymphoma Non-Hodgkin","Adverse Events",[63,64,65,66,60,67],"Fatigue","CAR-T cells","Chimeric antigen receptor","Adverse events","Nurse practitionners","2025-03-17",{"date":70,"type":37},"2025-03-21",{"date":72,"type":22},"2025-04-01",{"date":74,"type":22},"2026-05-01",{"name":43,"class":44},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100453908","early-integration-of-palliative-and-supportive-care-in-cellular-therapy-100453908","NCT05190653","Early Integration of Palliative and Supportive Care in Cellular Therapy","Early Integration of Palliative and Supportive Care for Patients and Family Caregivers Undergoing Hematopoietic Stem Cell Transplantation or Chimeric Antigen Receptor T-Cell Therapy: A Prospective Pragmatic Randomized Clinical Trial","PALS_CT","Inclusion Criteria - Patients\n\n* Clinical diagnosis of hematologic malignancy with scheduled hematopoietic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy\n* Ability to speak, read, and understand English or, be able to complete questionnaires with minimal assistance required from an interpreter\n\nInclusion Criteria - Family Caregivers\n\n* Family caregivers of patients with a clinical diagnosis of hematologic malignancy with scheduled hematopoietic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy\n* A spouse, relative, or friend, identified by the patient, who either lives with the patient or has in-person contact with the patient at least twice per week. Only one family CG per patient will be asked to participate.\n* Ability to speak, read, and understand English or willing to complete questionnaires with minimal assistance required from an interpreter\n\nExclusion Criteria - Patients\n\n* Patients undergoing HSCT for a non-malignant hematologic condition\n* Inability to provide informed consent\n\nExclusion Criterion - Family Caregivers\n\n\\* Inability to provide informed consent",{"count":85,"type":22},152,[87],"NA","Research has shown that early palliative care in cancer care is associated with improved symptom management, better prognostic understanding, improved quality of life for patients and family caregivers, and even improved survival. Yet, in spite of the proven benefits of integration of palliative care in oncology, it has been well established that patients with hematologic malignancies and those undergoing cellular therapy (hematopoietic stem cell transplantation (HSCT) and chimeric antigen receptor (CAR) T-cell therapy) do not routinely receive palliative care. Most of the published research on the early integration of palliative care in oncology describes studies that have involved patients with solid tumours. To date, only one randomized trial examining the impact of integrated palliative care among patients undergoing HSCT has been published and there have been no studies examining the impact of integrated palliative care for patients undergoing CAR T-cell therapy. The American Society of Clinical Oncology recommends early palliative care for patients with advanced cancers or for those with high symptom burden. Patients with blood cancers experience high symptom burden and in the last 30 days of life, compared to patients with solid tumours, patients with blood cancers are more likely to die in hospital, have more intensive care unit admissions, have prolonged hospitalizations (\\>14 days), and pass away in an acute care facility. There is an urgent need to proactively address suffering throughout cellular therapy trajectories, even before treatment starts, so that patients and caregivers are not inevitably waiting for symptoms to arise before they can be addressed and to optimize quality of life for patients undergoing transplant as well as their family caregivers.\n\nPALS\\_CT will compare early palliative care to standard care for patients and their family caregivers undergoing HSCT or CAR T-cell therapy for blood cancers.",[90,91,92,93,94,28],"Leukemia","Lymphoma","Multiple Myeloma","Blood Cancer","Stem Cell Transplant Complications",[96,97,98,99,100],"palliative care","supportive care","quality of life","symptom burden","hematologic malignancies","RECRUITING","2024-07-30",{"date":104,"type":37},"2024-07-31",{"date":106,"type":37},"2022-04-08",{"date":108,"type":22},"2025-12",{"name":110,"class":44},"Alberta Health Services, Calgary",1]