[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bambino Gesù Hospital and Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":293},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,44,68,98,125,167,204,236,263],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100640701","phase-1-fmt-for-pediatric-sr-agvhd-100640701",false,"NCT07602751","FMT for Pediatric SR-aGVHD","Fecal Microbiota Transplantation for the Treatment of Steroid-refractory Graft-versus-host Disease.","Inclusion Criteria:\n\n* Diagnosis of hematological disease, malignant or non-malignant;\n* Patients undergoing allogeneic stem cell transplantation from a familial or unrelated donor;\n* Presence of acute GVHD with intestinal involvement (grade II-IV), steroid-resistant (i.e., with progression after 3 days of high-dose steroid therapy (methylprednisolone \\> 2 mg\u002Fkg), no response after 7 days, progression during steroid tapering, or failure to achieve remission on day 28 from the start of steroid therapy), for those who have no indication for other second- or third-line therapies;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Presence of concurrent bacterial infections requiring systemic antibiotic therapy;\n* Positivity for anti-HIV or anti-HCV antibodies, or for HbsAg with HBV-DNA positive by PCR;\n* Presence of severe mucositis;\n* History of chronic inflammatory bowel disease.","ALL","3 Months","25 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a pilot, prospective, non-profit, multicenter, uncontrolled, open-label study to evaluate the safety and feasibility of FMT in patients aged between 3 months and 25 years suffering from acute intestinal GVHD resistant to conventional steroid therapy.\n\nEligible patients will receive 1-3 FMT via naso-jejunal tube or endoscopy.",[28],"Acute Graft Versus Host Disease in Intestine",[30],"graft-versus-host disease","NOT_YET_RECRUITING","2026-05-19",{"date":34,"type":35},"2026-05-22","ACTUAL",{"date":37,"type":21},"2026-05-18",{"date":39,"type":21},"2029-05",{"name":41,"class":42},"Bambino Gesù Hospital and Research Institute","OTHER",3,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":5},"100615846","phase-2-framework-for-optimizing-refining-and-unifying-management-of-hsct-in-pediatric-all-100615846","NCT07297914","Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL","FORUM2","Inclusion criteria applicable to all substudies\n\n* Male and female patients with allogenic transplant indication for ALL, as determined by national frontline protocols\n* Age ≥3 months to ≤25 years at the time of HSCT.\n* Patients must be in complete remission (with \\\u003C5% blasts and absence of leukemia cells in extramedullary sites) prior to undergoing HSCT.\n* Selected donor must be either a matched donor (matched donor category includes 9\u002F10 identical siblings and 10\u002F10 or 9\u002F10 HLA-matched unrelated donors) or a mismatched family donor (≤8\u002F10 HLA match). Either bone marrow or peripheral blood stem cell grafts are permitted. Cord blood is permitted, as well, provided that the unit is at least 6\u002F8 HLA matched and with a cryopreserved cellularity of at least 3x107 nucleated cells\u002FKg recipient body weight.\n* Female patients of childbearing potential must have a negative pregnancy test at screening, and all patients must agree to adhere to effective contraception during the study period.\n* Written study informed consent and\u002For assent from the patient and\u002For the parent, or guardian\n\nExclusion criteria applicable to all substudies\n\n* Patients \\\u003C 3 months and \\> 25 years of age at the time of HSCT.\n* Patients not in complete morphological remission at the time of enrollment.\n* Patients with an initial diagnosis of Non-Hodgkin Lymphoma (NHL).\n* Patients with ALL as a secondary malignancy.\n* Patients with a history of previous autologous or allogeneic HSCT (prior allogeneic transplantation is permitted for subjects receiving post-transplant interventions, such as those enrolled in the R2 and P1 substudies, provided that this is their first allogeneic HSCT).\n* Female patients who are pregnant or breast feeding.\n* Fertile male or female patients of childbearing potential who do not agree to abstinence or, if sexually active, do not agree to the use of contraception.\n* Active clinically uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no physical or radiographic signs of infection progression are present.\n* Active HBV or HCV infection that requires treatment, or at risk for HBV reactivation (e.g. positive HBsAg). Subjects with negative HbsAg and positive total HB core antibody may be included if HBV DNA is undetectable at the time of screening. Subjects who are positive for HCV antibody are eligible only if polymerase chain reaction test is negative for HCV RNA. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment. Prior serology results are acceptable for determining eligibility.\n* Known human immunodeficiency virus infection (HIV).\n* Significant respiratory disease including patients who are on mechanical ventilation or who have resting O2 saturation \\\u003C90% by pulse-oximetry on room-air.\n* Presence of severely impaired renal function (confirmed within 72 hours prior to study treatment start) defined by:\n* Glomerular Filtration Rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2 using estimated creatinine clearance calculated by updated bedside Schwartz equation or Cockcroft Gault equation OR\n* Renal dialysis requirement\n* Clinically significant or uncontrolled cardiac disease including any of the following:\n* Uncontrolled hypertension\n* New York Heart Association Class III or IV congestive heart failure\n* Clinically significant cardiac arrhythmias\n* Severe hepatic insufficiency, defined by any of the following:\n* Child-Pugh Class C liver disease\n* AST (aspartate aminotransferase) or ALT (alanine aminotransferase) levels \\> 5 times the upper limit of normal (ULN), unless attributable to GvHD\n* Total bilirubin \\> 3.0 mg\u002FdL, unless attributable to GvHD\n* INR (International Normalized Ratio) ≥ 1.7\n* Clinical evidence of hepatic encephalopathy or ascites\n* Presence of severe concomitant constitutional disease that precludes treatment as per protocol, based on the investigator's judgment. Examples include but are not limited to: Down syndrome with severe comorbidities, significant cardiac malformations, and metabolic disorders affecting treatment feasibility.\n* Underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere participation in the study, pose a significant risk to the patient or interfere with interpretation of study data.\n* Karnofsky or Lansky performance score \\\u003C50%, indicating significant functional impairment.\n* Patients who are unwilling or unable to comply with study procedures, including follow-up requirements and treatment schedules.",{"count":52,"type":21},1000,[25,54],"PHASE3","Current therapeutic strategies for high-risk or relapsed ALL patients often involve intensive treatments, including allogeneic hematopoietic stem cell transplantation (HSCT). HSCT remains a cornerstone of therapy, offering curative potential; however, it is associated with considerable risks, including non-relapse mortality (NRM), significant morbidity, and long-term complications that continue to be major concerns.\n\nIn response to these challenges, the FORUM consortium has made substantial progress in improving outcomes for children with ALL undergoing HSCT. The consortium focuses on reducing life-threatening and lifelong complications, ultimately aiming to enhance quality of life for these high-risk patients. Building on the robust evidence generated by FORUM1, the FORUM2 study has been designed to further optimize the role of HSCT in ALL across all age groups and donor settings within a harmonized and internationally coordinated framework.\n\nThe FORUM2 study introduces a master protocol structure that encompasses multiple hypothesis-driven substudies, each addressing a specific determinant of HSCT outcomes. This design enables simultaneous or sequential evaluation of novel strategies while ensuring uniform governance, endpoint definitions, and data-quality standards. The overarching objective is to refine the role of HSCT in ALL by reducing treatment-related toxicity while preserving the essential graft-versus-leukemia effect.",[57,58,59],"Acute Lymphoblastic Leukemia (ALL)","Stem Cell Transplant","Graft -Versus-host-disease","2025-12-17",{"date":62,"type":35},"2025-12-22",{"date":64,"type":21},"2026-01-15",{"date":66,"type":21},"2032-12-01",{"name":41,"class":42},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100522251","phase-1-allogeneic-second-generation-cd19-car-t-cells-for-pediatric-relapsedrefractory-b-all-100522251","NCT06080191","Allogeneic Second-generation CD19-CAR T Cells for Pediatric Relapsed\u002FRefractory B-ALL","Phase I Clinical Trial on the Use of Fresh, Allogeneic, Second-generation CD19-CAR T Cells for Treatment of Children With Relapsed\u002FRefractory B-cell Acute Lymphoblastic Leukemia","Patient Inclusion Criteria:\n\n1. Patients with a diagnosis of CD19 expressing B ALL relapse, and one of the following:\n\n   1. Relapse after alloHSCT OR\n   2. Relapsed\u002Frefractory disease, with failure of frontline therapy and at least 2 rescue strategies, including CD19\u002FCD22-directed monoclonal antibody and availability of a fully matched related donor.\n2. CD19+ count ≥ 50 cells\u002Fmcl and\u002For Minimal Residual Disease (MRD) ≥ 10\\^-4.\n3. Voluntary informed consent. For subjects \\\u003C 18-years old their legal guardian must give informed consent. Pediatric subjects will be included in age-appropriate discussion and verbal assent will be obtained for those greater than or equal to 12 years of age, when appropriate.\n4. Clinical performance status: patients \\> 16 years of age: Karnofsky greater than or equal to 60%; patients ≤ 16 years of age: Lansky score than or equal to 60%.\n5. Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for 4 months after receiving the lymphodepletion regimen.\n6. Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus.\n\nPatients Exclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Severe, uncontrolled active intercurrent infections.\n3. HIV, or active HCV and\u002For HBV infection.\n4. Life-expectancy \\\u003C 6 weeks or rapidly progressive disease that in the evaluation of the investigator would compromise ability to complete study therapy.\n5. Hepatic function: inadequate liver function defined as total bilirubin \\> 4x upper limit of normal (ULN) or transaminase (ALT and AST) \\> 6x ULN.\n6. Renal function: serum creatinine \\>3x ULN for age.\n7. Blood oxygen saturation \\\u003C 90%.\n8. Cardiac function: left ventricular ejection fraction lower than 45% by ECHO.\n9. Congestive heart failure, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject.\n10. Presence of active, grade 2-4 acute or chronic Graf versus Host Disease (GvHD) requiring steroid therapy or other immune-suppressive treatment.\n11. Relapse occurring before 60 days after alloHSCT.\n12. Concurrent or recent prior therapies, before infusion:\n\n    i. systemic steroids (at a dose of ≥ 2 mg\u002Fkg prednisone) in the 2 weeks before infusion of CD19-CAR\\_Lenti\\_ALLO cells . Recent or recurrent use of inhaled\u002Ftopical\u002Fnon-absorbable steroids is not exclusionary.\n\nii. systemic chemotherapy in the 2 weeks preceding infusion of CD19-CAR\\_Lenti\\_ALLO cells .\n\niii. anti-thymocyte globulin (ATG) or Alemtuzumab (Campath®)in the 8 weeks preceding infusion of CD19-CAR\\_Lenti\\_ALLO cells .\n\niv. immuno-suppressive agentis in the 2 weeks preceding infusion of CD19-CAR\\_Lenti\\_ALLO cells\n\nv. radiation therapy must have been completed at least 2 weeks before infusion of CD19-CAR\\_Lenti\\_ALLO cells .\n\nvi. other anti-neoplastic investigational agents currently administered or within 30 days prior to infusion of CD19-CAR\\_Lenti\\_ALLO cells (i.e, start of protocol therapy).\n\nvii. Exceptions:\n\n1. there is no time restrictions in regards to intrathecal chemotherapy, but there must be a complete recovery from any acute toxic effects from such treatment.\n2. subjects receiving steroid therapy at physiologic replacement doses only are allowed provided that there has been no increase for at least 2 weeks to starting apheresis.\n\nDonor Eligibility Criteria\n\nConventional criteria for the eligibility of allogeneic donors will be adopted for the evaluation of cell donors, before apheresis, as required by law.","1 Year","35 Years",{"count":78,"type":21},24,[24],"This is a phase I, open label study to evaluate the safety, identify the recommended dose (RD) and obtain preliminar evidence of the efficacy of allogeneic, CD19-directed Chimeric Antigen Receptor T (alloCAR-T) cells in pediatric and young adults patients with relapsed\u002Frefractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL).",[82],"B-cell Acute Lymphoblastic Leukemia",[84,85,86,87],"B-cell acute lymphoblastic leukemia","Children","Adolescent","Young adults","RECRUITING","2025-11-25",{"date":91,"type":35},"2025-12-02",{"date":93,"type":35},"2024-04-28",{"date":95,"type":21},"2041-06-01",{"name":41,"class":42},1,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":106,"maxAge":18,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":97},"100521077","phase-1-cd7-car-t-cells-in-pediatric-relapsedrefractory-cd7-t-allll-100521077","NCT06064903","CD7-CAR-T Cells in Pediatric Relapsed\u002FRefractory CD7+ T-ALL\u002FLL","Phase I\u002FII Study of Anti-CD7 Chimeric Antigen Receptor-Expressing T Cells in Pediatric Patients Affected by Relapsed\u002FRefractory CD7+ T-cell Acute Lymphoblastic Leukemia\u002FLymphoma","CD7-CAR01","Procurement eligibility\n\nInclusion Criteria:\n\n1. Diagnosis of CD7 expressing (\\> 98% CD7 expression on blast cells) T-ALL or LL and one of the following:\n\n   1. Patients in 1st or subsequent relapse, after at least one standard frontline chemotherapy with BM involvement (MRD \\>1% in 2 consecutive determinations or evidence of morphological relapse, i.e. \\>5% blasts in BM);\n   2. Relapse after allogeneic HSCT, if at least 100 days post-transplant, if there is no evidence of active GVHD and if the patient is no longer taking immunosuppressive agents for at least 30 days prior to enrollment;\n   3. CNS disease as defined as \\> 5 WBCs\u002FmcL in CSF with morphological\u002Fflow-cytometry evidence of blasts or biopsy proven recurrence in the eye or brain;\n   4. Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites;\n   5. Refractory disease, defined as MRD ≥ 1% or \\\u003C1% but persistently positive (i.e. a positive MRD value confirmed by PCR at 2 subsequent evaluations performed at least 2 weeks apart), at the end of consolidation blocks in newly diagnosed patients;\n2. Age: 6 months - 25 years.\n3. Adequate venous access for apheresis or eligible for appropriate catheter placement, and no other contraindications for leukapheresis.\n4. Voluntary informed consent is given. For subjects \\\u003C18-year-old, or below the age required by each Country regulation, their legal guardian must give informed consent. Pediatric subjects will be included in age-appropriate discussion and verbal assent will be obtained for those greater than or equal to 12 years of age, when appropriate, or to sign age-adapted informed consent, according to the regulatory requirement of each Country.\n5. Clinical performance status: Patients \\> 16 years of age: Karnofsky greater than or equal to 60%; Patients \\\u003C 16 years of age: Lansky scale greater than or equal to 60%.\n\nExclusion Criteria:\n\n1. Severe, uncontrolled active intercurrent infections.\n2. HIV, or active HCV and\u002For HBV infection.\n3. Blast contamination in peripheral blood \\>5%, by flow-cytometry, at the time of leukapheresis collection.\n4. Concurrent or recent prior therapies, before apheresis:\n\n   1. Systemic steroids (at a dose equivalent to or greater than 2 mg\u002Fkg prednisone) in the 2 weeks before apheresis collection. Recent or current use of inhaled\u002Ftopical\u002Fnon-absorbable steroids is not exclusionary\n   2. Systemic chemotherapy in the 2 weeks preceding apheresis collection\n   3. Nelarabine, daratumomab, clofarabine exposure in the 3 weeks preceding apheresis collection\n   4. Anti-thymocyte globulin (ATG) or Alemtuzumab (Campath®) in the 8 weeks preceding apheresis collection\n   5. Immunosuppressive agents in the 2 weeks preceding apheresis collection\n   6. Radiation therapy must have been completed at least 2 weeks prior to apheresis\n   7. Other anti-neoplastic investigational agents currently administered or within 30 days prior to apheresis (i.e. start of protocol therapy)\n   8. Exceptions:\n\n      * There is no time restriction with regard to prior intrathecal chemotherapy, provided that there is complete recovery from any acute toxic effects of such chemotherapy;\n      * Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study provided they meet all other eligibility criteria;\n      * Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis.\n\nTreatment eligibility\n\nInclusion criteria:\n\n1. Diagnosis of CD7 expressing (\\> 98% CD7 expression on blast cells) T-ALL or LL and one of the following:\n\n   1. Patients in 1st or subsequent relapse, after at least one standard frontline chemotherapy with BM involvement (MRD \\>1% in 2 consecutive determinations or evidence of morphological relapse, i.e. \\>5% blasts in BM)\n   2. Relapse after allogeneic HSCT, if at least 100 days post-transplant, if there is no evidence of active GVHD and if the patient is no longer taking immunosuppressive agents for at least 30 days prior to enrollment\n   3. CNS disease as defined as \\> 5 WBCs\u002FmcL in CSF with morphological or flow-cytometry evidence of blasts or biopsy proven recurrence in the eye or brain\n   4. Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites\n   5. Refractory disease, defined as MRD ≥1% or \\\u003C1% but persistently positive (i.e. a positive MRD value confirmed by PCR at 2 subsequent evaluations performed at least 2 weeks apart), at the end of consolidation blocks in newly diagnosed patients\n2. Measurable or evaluable disease at the time of enrollment, which may include any evidence of disease, including MRD detected by flow-cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis.\n3. Age: 6 months - 25 years.\n4. Before enrollment for treatment, patients must have a potential allogeneic hematopoietic stem cell (HSC) donor (matched related, matched unrelated or haploidentical) available.\n5. Voluntary informed consent is given. For subjects \\\u003C18-year-old, or below the age required according to each Country regulation, their legal guardian must give informed consent. Pediatric subjects will be included in age-appropriate discussion and verbal assent will be obtained for those greater than or equal to 12 years of age, when appropriate, or to sign age-adapted informed consent, according to the regulatory requirement of the Country.\n6. Clinical performance status: Patients \\> 16 years of age: Karnofsky greater than or equal to 60%; Patients \\\u003C 16 years of age: Lansky scale greater than or equal to 60%.\n\nExclusion criteria:\n\n1. Pregnant or lactating women.\n2. Severe, uncontrolled active intercurrent infections.\n3. HIV, or active HCV and\u002For HBV infection.\n4. Life-expectancy \\\u003C 6 weeks.\n5. Hepatic function: Inadequate liver function defined as total bilirubin \\> 4x upper limit of normal (ULN) or transaminase (ALT and AST) \\> 6 x ULN.\n6. Renal function: serum creatinine \\> 3x ULN for age.\n7. Blood oxygen saturation \\\u003C 90%.\n8. Cardiac function: Left ventricular ejection fraction lower than 45% by ECHO.\n9. Congestive heart failure, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject.\n10. 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).\n11. Contamination of either the apheresis collection or the CD7-CART01 drug product with \\>5% blasts.\n12. Presence of active, grade 2-4 acute or extensive chronic GvHD.\n13. Concurrent or recent prior therapies, before infusion:\n\n    1. Systemic steroids (at a dose \\> 2 mg\u002Fkg prednisone) in the 2 weeks before infusion. Recent or current use of inhaled\u002Ftopical\u002Fnon-absorbable steroids is not exclusionary\n    2. Systemic chemotherapy in the 2 weeks preceding infusion\n    3. Anti-thymocyte globulin (ATG) or Alemtuzumab (Campath®) in the 8 weeks preceding infusion\n    4. Immunosuppressive agents in the 2 weeks preceding infusion\n    5. Radiation therapy must have been completed at least 3 weeks prior to enrollment\n    6. Other anti-neoplastic investigational agents currently administered or within 30 days prior to infusion (i.e., start of protocol therapy)\n    7. Exceptions:\n\n       * There is no time restriction in regards to prior intrathecal chemotherapy but there must be a complete recovery from any acute toxic effects from such chemotherapy;\n       * Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study provided that they meet all other eligibility criteria;\n       * Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided that there has been no increase in dose for at least 2 weeks prior to starting apheresis.","6 Months",{"count":108,"type":21},26,[24,25],"The main purpose of this study is to evaluate the safety, to establish the recommended dose, and to evaluate the antitumor effect of CD7-CART01 in pediatric patients with relapsed or refractory (R\u002FR) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LL).",[112],"T-Cell Acute Lymphoblastic Leukemia\u002FLymphoblastic Lymphoma",[114,115,116,117,118],"T-ALL","T-LL","Relapsed","Refractory","anti-CD7 PEBL-CAR T",{"date":91,"type":35},{"date":121,"type":35},"2024-04-21",{"date":123,"type":21},"2040-09-30",{"name":41,"class":42},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},"100587695","reprogramming-energy-homeostasis-in-overweight-individuals-via-exercise-cognitive-and-social-training-100587695","NCT06931730","Reprogramming Energy Homeostasis in Overweight Individuals Via Exercise, Cognitive, and Social Training","Reprogramming Energy Homeostasis in Overweight Children and Adults Trough Exercise, Cognitive Training and Social Interaction","Resilient","Inclusion Criteria:\n\n* a condition of overweight or obesity\n* Intelligence Quotient (IQ) ≥ 85\n\nExclusion Criteria:\n\n* genetic or syndromic obesity;\n* reduced mobility;\n* systemic diseases;\n* ongoing pharmacological treatment for chronic conditions.","6 Years","11 Years",{"count":136,"type":21},240,[138],"NA","The RESILIENT project is a clinical trial investigating leptin sensitivity in both children and adults with overweight or obesity. The study examines the additive effects of Cognitive Training (CT) and Social Training (ST) on leptin sensitivity, compared to stand-alone Intensive Health Behaviour Treatment (IHBT), which includes diet and Physical Activity (PA).\n\nThe intervention will last for 8 weeks, followed by a 12-week washout period. A multilevel assessment will be conducted, evaluating in vivo leptin sensitivity (through the ratio of leptin levels to caloric intake) as well as ex vivo molecular analysis of leptin signaling in Peripheral Blood Mononuclear Cells (PBMCs). Additionally, clinical, psychological, cognitive, and physiological assessments will be performed to assess the efficacy of each intervention. By investigating leptin resistance as a potential molecular bridge between metabolic dysregulation and cognitive dysfunctions, this study may contribute to the development of more effective, long-term treatments for obesity and overweight. Additionally, in vivo investigation of leptin sensitivity may be particularly important for providing evidence of the metabolic and cognitive effects necessary for developing novel anti-obesity treatments.",[141,142,143],"Obesity and Overweight","Leptin Resistance","Childhood Obesity",[145,146,147,148,149,150,151,152,153,154,155,156,157],"childhood obesity","cognitive training","social training","environmental enrichment","leptin","lifestyle modification","overweight","obesity","energy expenditure","thermogenesis","physical activity","leptin sensitivity","leptin resistance","2025-04-09",{"date":160,"type":35},"2025-04-17",{"date":162,"type":35},"2024-02-08",{"date":164,"type":21},"2025-12-31",{"name":41,"class":42},2,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":106,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":187,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":97},"100462233","phase-1-gd2-car-t-cells-for-pediatric-brain-tumours-100462233","NCT05298995","GD2-CAR T Cells for Pediatric Brain Tumours","Phase I Study of Anti-GD2 Chimeric Antigen Receptor-Expressing T Cells in Pediatric and Young Adult Patients Affected by Relapsed\u002FRefractory Central Nervous System Tumors","Inclusion Criteria:\n\n1. Imaging assessments performed within 14 days of start of treatment\n2. Age: 6months-30years\n3. Measurable or evaluable disease on at least 2 dimensions on MRI at the time of treatment enrollment\n4. Karnofsky\u002FLansky≥60\n5. Recoverfromthetoxiceffectsofpreviousradiationandchemotherapies:grade4and or 3 non-hematologic toxicities must have resolved to grade ≤ 2; in presence of chronic complications (i.e. treatment-associated thrombocytopenia), patient must be clinically stable, according to the opinion of the treating physicians, and meet all other eligibility criteria\n6. Positioning of an implantable intraventricular access device (CodmanHolterRickham reservoir, Integra LifeSciences, NJ, U.S.A) and a microdialysis probe (71 high cutoff microdialysis bolt catheter, M Dialysis AB, Stockholm Sweden)\n7. Written and signed informed consent from patients, parents or legal guardians. For subjects \\\u003C 18 year-old their legal guardian must give informed consent. In addition, pediatric subjects will be included in age-appropriate discussion and written informed assent will be obtained for those greater than or equal to 7 years of age, when appropriate\n8. Patients of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen\n9. Females of childbearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Severe,uncontrolledactiveinfections\n3. HIV or active HCV and\u002For HBV infection\n4. Rapidly progressive disease with life expectancy \\\u003C 6 weeks\n5. Historyofgrade3or4hypersensitivitytomurineprotein-containingproducts\n6. Hepatic function: inadequate liver function defined as total bilirubin \\> 4x upper limit of normal (ULN) or transaminase (ALT and AST) \\> 6 x ULN based on age and laboratory specific normal ranges\n7. Renal function: serum creatinine \\> 3x ULN for age\n8. Blood oxygen saturation \\\u003C 90%\n9. Cardiac function: left ventricular ejection fraction lower than 45% by ECHO\n10. Marrow function: absolute neutrophils count (ANC) lower than 500\u002Fmm3 and\u002For platelets lower than 20.000 (not reached by transfusion)\n11. Congestive heart failure, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the principal investigator (PI) would pose an unacceptable risk to the subject. 12.Concurrent or recent prior therapies, before infusion:\n\n    1. If receiving glucocorticoids, patient must be on a stable or weaning dose for at least 7 days prior to infusion. Recent or current use of inhaled\u002Ftopical\u002Fnon- absorbable steroids is not exclusionary. Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis\n    2. Systemic chemotherapy in the 3 weeks preceding infusion\n    3. Immunosuppressive agents less than or equal to 30 days\n    4. Radiation therapy must have been completed at least 6 weeks prior to enrollment\n    5. Otheranti-neoplasticinvestigationalagentscurrentlyorwithin30dayspriorto start of protocol therapy\n\n13.Patient-derived GD2-CART01 production failure: vitality \\\u003C80%, CD3+ cells \\\u003C80%, CD3+ CAR+ cells \\\u003C20%, CD3+ CAR+ antitumor activity \\\u003C60% in functional co-culture assay at an Effector: Target ratio 1:1, viable CAR+ cells upon AP1903 exposition \\>20%, RCR positivity, Vector Copy Number \\>10, non-sterility, endotoxin contamination (\\> 1 EU\u002Fml)","30 Years",{"count":176,"type":21},54,[24],"The purpose of this study is to test the safety and efficacy of iC9-GD2-CAR T-cells, a third generation (4.1BB-CD28) CAR T cell treatment targeting GD2 in paediatric or young adult patients affected by relapsed\u002Frefractory malignant central nervous system (CNS) tumors. In order to improve the safety of the approach, the suicide gene inducible Caspase 9 (iC9) has been included.",[180,181,182,183,184,185,186],"Brain Tumor, Pediatric","Medulloblastoma, Childhood","Embryonal Tumor","High Grade Glioma","Diffuse Midline Glioma","Diffuse Intrinsic Pontine Glioma","Brain Tumor Adult",[188,189,190,184,185,191,192,193,194,195],"Brain tumors","high grade glioma","medulloblastoma","CAR T cell","GD2-antigen","Immunotherapy","Pediatric Central Nervous System tumours","Central nervous system tumour young adults","2025-02-03",{"date":198,"type":35},"2025-02-05",{"date":200,"type":35},"2023-11-09",{"date":202,"type":21},"2038-11",{"name":41,"class":42},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":211,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":219,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":235,"locationsCount":97},"100568180","group-cbt-in-adolescents-with-fragile-x-syndrome-and-in-adolescents-with-autism-spectrum-disorder-100568180","NCT06677866","Group CBT in Adolescents With Fragile X Syndrome and in Adolescents With Autism Spectrum Disorder","Effectiveness of Cooperative Group Therapy in Adolescents With Fragile X Syndrome (FXS) and in Adolescents With Autism Spectrum Disorder (ASD)","FXS group:\n\nInclusion Criteria\n\n* Clinical diagnosis of FXS confirmed by genetic testing.\n* Age between 13 and 19 years.\n* Language skills compatible with group intervention (verbal language at sentence level).\n* Impairment in adaptive functioning measured by VABS II \\\u003C 70.\n* Informed consent for participation and data processing provided by parents. Exclusion Criteria\n* Severe visual or hearing impairments.\n* Diagnosis of epilepsy or a history of seizures requiring medication.\n* Participation in other non-pharmacological treatments.\n* Changes in pharmacological therapy within the last 3 months.\n* Presence of medical problems or behaviors that could interfere with group activities, as measured by the Autism Behavior Checklist (ABC) (ABC Irritability Scale \\\u003C 18).\n* IQ \\\u003C 40 measured by the Leiter third edition (Leiter 3)\n* Severe adaptive functioning, measured by VABS II \\\u003C 20.\n\nASD group:\n\nInclusion Criteria\n\n* Clinical diagnosis of Autism Spectrum Disorder (ASD) confirmed by ADOS-2 and ADI-R interviews.\n* Age between 13 and 19 years.\n* Language skills compatible with group intervention (verbal language at sentence level).\n* Impairment in adaptive functioning measured by VABS II \\\u003C 70.\n* Informed consent for participation and data processing provided by parents.\n\nExclusion Criteria\n\n* Severe visual or hearing impairments.\n* Identification of specific genetic abnormalities or presence of known genetic syndromes associated with ASD (e.g., TSC, FXS, 22q11, 16p11.2, Rett Syndrome).\n* Diagnosis of epilepsy or a history of seizures requiring medication.\n* Participation in other non-pharmacological treatments.\n* Changes in pharmacological therapy within the last 3 months.\n* Presence of medical problems or behaviors that could interfere with group activities, as measured by the Autism Behavior Checklist (ABC) (ABC Irritability Scale \\\u003C 18).\n* IQ \\\u003C 40 measured by the Leiter third edition (Leiter 3)\n* Severe adaptive functioning, measured by VABS II \\\u003C 20.","13 Years","19 Years",{"count":20,"type":21},[138],"Fragile X Syndrome (FXS) is a rare genetic syndrome, caused by a mutation in the FMR1 gene located on the X chromosome. It is considered the leading hereditary cause of intellectual disability (ID) and the primary cause of Autism Spectrum Disorder (ASD) due to a single gene-mutation. Many individuals with FXS exhibit symptoms overlapping with those of ASD, including difficulties in social-communication skills, challenges in peer relationships, restricted and repetitive behaviors\u002Finterests and deficits in adaptive functioning. Both in ASD and FXS, individuals with greater deficits in executive functions, socio-pragmatic, and socio-relational skills also demonstrate lower adaptive functioning and, consequently, reduced autonomy\u002Findependence throughout the life course and greater severity of the disorder.\n\nAmong empirically validated treatments recommended by National and International Guidelines for the treatment of ASD, cognitive-behavioral and psychosocial interventions have been shown to improve some aspects of ASD, such as core symptoms, emotional-behavioral disturbances, adaptive skills, and quality of life. Currently, it appears that cognitive-behavioral therapies, which include psychoeducation programs, are particularly appropriate for ASD, with greater efficacy for group interventions compared to individual ones. Regarding FXS, despite the well-established knowledge of the cognitive-behavioral phenotype and the clear need for scientifically validated programs, research on intervention strategies remains quite limited.\n\nConsidering the similarities between ASD and FXS and the need for standardized interventions, the present research project aims to conduct an RCT to evaluate the feasibility of Cooperative Group Therapy (CGT) in two different groups of adolescents with ASD and FXS. The decision to target the intervention to adolescents is due to the few clinical studies on this age group, which is a crucial target since, in FXS, there is often a plateau or reversal of intellectual and adaptive development after the age of 10, and in adolescents with ASD, the development and complexity of social, pragmatic skills, and executive functions are crucial for good adaptive functioning and a basic quality of life. Te main hypothesis is that CGT could contribute to the reduction of severity illness and in the enhancement of socio-communicative skills.",[217,218],"Fragile X Syndrome (FXS)","Autism Spectrum Disorder",[220,221,222,223,224,225,226,227,228],"intellectual disability","adaptive functioning","quality of life","rare genetic syndrome","Cognitive Behavioral Therapy","CBT","fragile x syndrome","autism spectrum disorder","neuropsychology","2024-11-07",{"date":231,"type":35},"2024-11-08",{"date":233,"type":35},"2022-09-01",{"date":164,"type":21},{"name":41,"class":42},{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":243,"maxAge":211,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":97},"100565700","targeting-repetitive-behaviors-in-autism-spectrum-disorder-via-transcranial-direct-current-stimulation-100565700","NCT06645587","Targeting Repetitive Behaviors in Autism Spectrum Disorder Via Transcranial Direct Current Stimulation","Understanding and Targeting Repetitive Behaviors and Restricted Interests in Autism Spectrum Disorder Via High-Definition Transcranial Direct Current Stimulation","Inclusion Criteria:\n\n* participants of both genders with ASD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and based on clinical evaluation and administration of gold standard tools for ASD diagnosis\n* an intelligence quotient (IQ) higher or equal to 70 (IQ ≥ 70)\n* age range from 8 years to 13 years and 11 months included\n\nExclusion Criteria:\n\n* the presence of neurological\u002Fmedical\u002Fgenetic conditions (i.e., brain tumours or genetic syndromes)\n* personal or family history of epilepsy\n* other primary psychiatric diagnoses (i.e., bipolar disorders, schizophrenia spectrum disorders, or adjustment disorder)\n* sensorimotor deficits\n* the presence of peacemaker or other metal devices in the body;\n* ongoing CNS-active drug treatment\n* receiving other cognitive-behavioral therapies specifically focused on RBs in the 3 months before the study","8 Years",{"count":245,"type":21},78,[138],"Repetitive behaviors (RBs) are a prevalent feature of Autism Spectrum Disorder (ASD). There are two groups of RBs: lower-order (e.g. motor stereotypies) and higher-order RBs (e.g. restricted interests), linked to sensory-motor and the associative loops, respectively. To date, treatment options for RBs are very limited. High-definition transcranial direct current stimulation (HD-tDCS) may be effective in reducing the impact of RBs in children with ASD by targeting the associated brain alterations. Moreover, the high focality of HD-tDCS will help the investigators to disentangle the relative contribution of different brain loops (namely, sensory-motor and the associative loops) into RBs subtypes. The investigators will also study the electrophysiological patterns associated to behavioral changes after the application of HD-tDCS.",[218],[218,250,251,252,253,254],"HD-tDCS","Restricted Interests","Repetitive Behaviors","Neurodevelopmental Disorders","transcranial direct current stimulation","2024-10-15",{"date":257,"type":35},"2024-10-17",{"date":259,"type":35},"2024-10-03",{"date":261,"type":21},"2026-04",{"name":41,"class":42},{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":270,"sex":16,"minAge":243,"maxAge":211,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":277,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":97},"100513955","v5mt-stimulation-on-reading-and-reading-related-measures-in-developmental-dyslexia-100513955","NCT05972200","V5\u002FMT Stimulation on Reading and Reading-related Measures in Developmental Dyslexia","Probing the Efficacy of V5\u002FMT Stimulation on Reading and Reading-related Measures in Children and Adolescents With Developmental Dyslexia","Inclusion Criteria:\n\n* Italian speakers right-handed children and adolescents with dyslexia (DSM-5, APA 2013);\n* Word\u002Fnonword\u002Ftext reading accuracy and\u002For speed at least 2 Standard Deviations below the mean for school-age;\n* nv IQ ≥ 85;\n* normal hearing and normal or corrected-to-normal vision.\n\nExclusion Criteria:\n\n* Having a comorbidity with other primary psychiatric\u002Fneurological diagnosis (e.g., depression, anxiety, autism, ADHD);\n* Having a personal history of neurological\u002Fmedical\u002Fgenetic diseases;\n* Having ongoing drug treatment influencing brain function;\n* Having epilepsy o family history of epilepsy.",true,{"count":272,"type":21},36,[138],"The present study grounds on the absence of evidence-based treatment in individuals with developmental dyslexia (DD). At this topic, the present study will explore the potential effect of transcranial direct current stimulation (tDCS) over left hemispheric direct Lateral Geniculate Nucleus (LGN)-V5\u002FMT pathway, cerebral areas usually disrupted in individuals with DD.\n\nThe investigators hypothesized that active tDCS over V5\u002FMT will boost reading skills in children and adolescents with DD. On the contrary, sham (placebo condition) tDCS over V5\u002FMT or active (control condition) tDCS over V1 will not have significant effect in improving reading skills. Further, both active and sham tDCS will be safe and well tolerated.",[276],"Developmental Dyslexia",[85,278,279,254,280,281,282,283,284],"Adolescents","tDCS","neurodevelopmental disorders","non-invasive brain stimulation","transcranial electrical stimulation","EEG","reading abilities","2023-08-02",{"date":287,"type":35},"2023-08-04",{"date":289,"type":21},"2023-09-01",{"date":291,"type":21},"2026-08-31",{"name":41,"class":42},""]