[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapse\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapse":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,46,58,85,107,130,158,181,213,236,269,293,318,341,363,382,409,432,459,496,517,544,566,592],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100053502","phase-1-study-of-autologous-car-t-cells-targeting-b7-h3-in-tnbc-ic9-carb7-h3-t-cells-100053502",false,"NCT06347068","Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells","Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative Breast Cancer","Inclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study:\n\n1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60% (see APPENDIX VI- Karnofsky Scale))\n4. Histologically confirmed TNBC (ER-, PR-, HER2-negative)\n\n   1. ER- and PR-negative: defined as \\\u003C 1% staining by immunohistochemistry (IHC)\n   2. HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \\\u003C 2.0\n\nExclusion Criteria:\n\n1. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.\n2. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n3. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1","ALL","18 Years",{"count":19,"type":20},42,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed\u002Frefractory triple-negative breast cancer (TNBC).",[26,27,28,29],"Breast Cancer","Relapse","Resistant Cancer","Triple Negative Breast Cancer",[31,32],"cellular therapy","biologic therapy","RECRUITING","2026-07-09",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":37},"2024-06-27",{"date":41,"type":20},"2030-05",{"name":43,"class":44},"UNC Lineberger Comprehensive Cancer Center","OTHER",1,{"id":47,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":24,"conditions":50,"keywords":51,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":56,"leadSponsor":57,"locationsCount":45},"100542761",{"count":19,"type":20},[23],[26,27,28,29],[31,32],"2026-06-23",{"date":54,"type":37},"2026-06-25",{"date":39,"type":37},{"date":41,"type":20},{"name":43,"class":44},{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":45},"100563637","motivational-interviews-post-hospitalisation-on-maintaining-abstinence-for-1-year-aprs-le-sevrage-en-alcool-100563637","NCT06618755","Motivational Interviews Post Hospitalisation on Maintaining AbstiNence for 1 Year après le Sevrage en Alcool","IMMANENCE - Intérêt d'un Suivi Sous Forme d'Entretiens Motivationnels spécifiques Post Hospitalisation Sur le Maintien de l'AbstiNENCE Durant l'année Suivant le Sevrage en Alcool","IMMANENCE","Inclusion Criteria:\n\n* With alcohol use disorders defined by at least 2 DSM-V criteria for at least 12 months).\n* Being treated for withdrawal in hospital.\n* With a goal of complete abstinence.\n* With a means of communication (telephone).\n\nExclusion Criteria:\n\n* Lack of understanding (written and spoken) of the French language.\n* Breach of HC withdrawal contract, following failure to comply with the rules of the addictology service and somatic complications of addiction.\n* Eviction from the department, discharge against medical advice during hospitalisation for withdrawal.\n* Proven cognitive problems compromising understanding of the implications of the study and the proposed follow-up. proposed follow-up.\n* Serious decompensated somatic pathology.\n* Non-membership or non-beneficiaries of a national health insurance scheme.\n* Person protected by law, under guardianship or curatorship.\n* Not having signed free and informed consent to participate in the research.\n* Simultaneous participation in another clinical trial.",{"count":67,"type":20},104,[69],"NA","The aim of this clinical study is to evaluate the efficacy of reinforced inpatient aftercare versus usual care on the percentage of days of abstinence during the first year following withdrawal in adults with alcohol use disorders undergoing inpatient withdrawal. The hypothesis is that reinforced post-withdrawal follow-up, of the motivational interview type, during the first 4 months following hospitalisation, in addition to the usual care, would allow :\n\n* Increase the percentage of days of abstinence in the year following withdrawal.\n* Reduce the rate of relapse in the year following withdrawal.\n* An increase in the cumulative and maximum duration of abstinence, an increase in motivation to maintain the change initiated and a reduction in the use of other substances in the year following withdrawal.\n* A reduction in the impact of risk factors involved in the relapse process in the year following withdrawal.\n\nAll participants will have assessments to monitor their abstinence and consumption. In addition to their assessments, the experimental group will have motivational talks once every 15 days.",[72,73,74,75,27],"Alcohol Use Disorder","Addiction","Alcohol Withdrawal","Motivational Interviews","2026-06-17",{"date":78,"type":37},"2026-06-18",{"date":80,"type":37},"2024-12-18",{"date":82,"type":20},"2028-01-13",{"name":84,"class":44},"University Hospital, Montpellier",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":45},"100528236","phase-1-autologous-car-t-cells-targeting-b7-h3-in-pdac-100528236","NCT06158139","Autologous CAR-T Cells Targeting B7-H3 in PDAC","A Phase I Study of Autologous CAR-T Cells Targeting the B7-H3 Antigen and Containing the Inducible Caspase 9 Safety Switch in Subjects With Refractory Pancreatic Ductal Adenocarcinoma (PDAC)","Inclusion Criteria:\n\n1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for releasing personal health information explained to, understood by, and signed by the subject or legally authorized representative.\n2. Age ≥ 18 years at the time of consent.\n3. Eastern Cooperative Oncology Group of 0-1 Performance Status)\n4. Histological or cytological evidence\u002Fconfirmation of pancreatic ductal adenocarcinoma.\n5. Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets \\\u003C 1% failure rate for protection from pregnancy in the product label.\n6. Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 3 months after the cell infusion therapy.\n\nExclusion Criteria:\n\n1. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n2. Subject is not willing and able to comply with study procedures based on the judgment of the investigator.",{"count":93,"type":20},27,[23],"The purpose of this gene therapy research study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9.CAR.B7-H3 T cells) in patients with pancreatic ductal adenocarcinoma that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration.",[97,27,28],"Pancreas Cancer",[31],"2026-06-05",{"date":101,"type":37},"2026-06-08",{"date":103,"type":37},"2024-07-18",{"date":105,"type":20},"2030-04",{"name":43,"class":44},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":16,"minAge":17,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":45},"100640092","comparative-3-dimensional-superimposition-analysis-of-dentition-in-horizontal-and-vertical-grower-during-the-retention-phase--a-prospective-clinical-trial-100640092","NCT07622277","Comparative 3-dimensional Superimposition Analysis of Dentition in Horizontal and Vertical Grower During the Retention Phase -A Prospective Clinical Trial''","Inclusion Criteria:\n\n* Fixed orthodontic cases with FMA of 26 0 or more for hyperdivergent cases and FMA Of 24 o or less for hypodivergent cases.\n* Optimal functional occlusion at end of treatment (PAR score \\>70%).\n* Littles irregularity index (Pre-treatment \\\u003C6mm in both upper and lower arch).\n* Nonsurgical and non-orthopedic patients and non syndromic patients.\n* Optimal periodontal condition and Good oral hygiene (probing depth \\\u003C3mm, gingival index score \\\u003C1\n* Good compliance regarding retainer wear\n\nExclusion Criteria:\n\n* Subjects with incomplete orthodontic treatment.\n* TMJ disorder patients.\n* Any systemic disease affecting bone and general growth.\n* Patients with incomplete records\n* Patient who fail to follow up or undergo complete treatment.\n* Patient with learning difficulties\n* Patients having antibiotic therapy within previous 3 months and used anti inflammatory drugs in the month before the study",true,"45 Years",{"count":116,"type":20},44,[69],"This study aims to investigate the relationship between facial type and relapse of dentition post-orthodontically during the retention phase. According to the retention theorem \"teeth which have been moved through orthodontic treatment tend to naturally return to their original position. It is hypothesized that significant differences will exist in tooth movement patterns between horizontal and vertical growers, with horizontal growers exhibiting more pronounced tooth movement in the vertical plane particularly in the overbite as compared to the vertical growers . Furthermore, it is expected that facial type will influence the stability of orthodontic treatment outcomes, with long-faced individuals showing more relapse of mandibular incisor alignment and crowding. By exploring this relationship, this study aims to provide valuable insights into the factors influencing orthodontic treatment outcomes and stability. With long-faced individuals exhibiting more mandibular backward rotation and short-faced individuals showing forward rotation, which increases the risk of deep bite . Additionally, understanding these factors is crucial for orthodontists to predict and prevent potential relapse, ensuring optimal treatment results and long-term stability. Hence, the present trial will be undertaken to assess the changes and compare If there is any difference in tooth movement in 3-Dimensional superimposition in the dentition in horizontal and vertical growers post orthodontically over a period of retention phase.",[120,27],"Retention","2026-05-30",{"date":123,"type":37},"2026-06-03",{"date":125,"type":37},"2025-02-04",{"date":127,"type":20},"2027-07",{"name":129,"class":44},"Postgraduate Institute of Dental Sciences Rohtak",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"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":147,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":45},"100638551","multi-omics-inflammatory-phenotype-for-abpa-recurrence-risk-prediction-100638551","NCT07611838","Multi-Omics Inflammatory Phenotype for ABPA Recurrence Risk Prediction","Multi-Omics Data-Derived Inflammatory Phenotype for ABPA Recurrence Risk Prediction: A Multicenter Study","Inclusion Criteria:\n\n* Female and Male patients aged 18-80 years\n* diagnosis of Allergic Bronchopulmonary Aspergillosis ABPA accroding to the 2024 ISHAM Working Group Diagnostic Criteria\n\nExclusion Criteria:\n\n* Patients with malignant tumors or severe organ dysfunction (e.g., cardiac, cerebral, renal, etc.)\n* Patients with severe comorbidities, including active pulmonary tuberculosis, lung cancer, chronic heart failure (NYHA class Ⅳ), chronic kidney disease (CKD stage 5), decompensated cirrhosis, etc.\n* Patients with immunosuppressive status, such as HIV infection, long-term use of oral corticosteroids or immunosuppressive agents.\n* Pregnant or lactating women.\n* Patients with missing key data or incomplete medical records.","80 Years",{"count":139,"type":20},300,"OBSERVATIONAL","To develop and externally validate a machine learning model for predicting the 1-year risk of relapse in patients with stable ABPA, and to further evaluate its value in risk stratification and clinical decision-making.",[143,144,145,146,27],"Allergic Bronchopulmonary Aspergillosis (ABPA)","Machine Learning","Multi-omics","Multicenter Study",[148,27,144,146,145],"Allergic Bronchopulmonary Aspergillosis","2026-05-28",{"date":151,"type":37},"2026-06-01",{"date":153,"type":37},"2021-01-01",{"date":155,"type":20},"2028-12-31",{"name":157,"class":44},"Qianfoshan Hospital",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":45},"100637437","phase-2-a-phase-ii-randomized-trial-of-serplulimab-with-second-line-chemotargeted-therapy-for-early-relapse-colorectal-cancer-after-adjuvant-chemotherapy-100637437","NCT07604909","A Phase II Randomized Trial of Serplulimab With Second-Line Chemo\u002FTargeted Therapy for Early Relapse Colorectal Cancer After Adjuvant Chemotherapy","A Phase II, Prospective, Randomized Study of Serplulimab Plus Second-Line Chemotherapy and Targeted Therapy vs Second-Line Chemotherapy and Targeted Therapy Alone in Patients With Early Relapse of Colorectal Cancer After Adjuvant Chemotherapy","Inclusion Criteria:\n\nAge ≥18 years, male or female. Histologically confirmed early relapse (within 1 year after surgery, UICC stage IV) of colorectal cancer after adjuvant chemotherapy, with initially unresectable metastatic lesions or refusal of surgery.\n\nHave received standard postoperative adjuvant chemotherapy (XELOX or FOLFOX). Before enrollment, tumor tissue tested by immunohistochemistry as pMMR, or by PCR or NGS as MSS or MSI-L.\n\nAt least one measurable tumor lesion according to RECIST 1.1 criteria. ECOG performance status 0-1. Life expectancy ≥3 months.\n\nAdequate organ function:\n\n1. Neutrophils ≥1.5 × 10⁹\u002FL; platelets ≥100 × 10⁹\u002FL; hemoglobin ≥9 g\u002FdL; serum albumin ≥3 g\u002FdL.\n2. Thyroid-stimulating hormone (TSH) ≤ upper limit of normal (ULN), with T3 and T4 within normal range.\n3. Bilirubin ≤1.5 × ULN; ALT and AST ≤2 × ULN.\n4. Serum creatinine ≤1.5 × ULN, creatinine clearance ≥60 mL\u002Fmin.\n5. International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN, unless the patient is receiving anticoagulant therapy and PT is within the expected therapeutic range for anticoagulation.\n6. Activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Female patients of childbearing potential must have a negative pregnancy test. Female patients not of childbearing potential, fertile male patients, and female patients of childbearing potential at risk of pregnancy must agree to use adequate contraception throughout the study and for 12 months after the last dose of study treatment.\n\nSigned and dated written informed consent indicating that the patient has been informed of all relevant aspects of the study.\n\nWilling and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\nPathologically diagnosed other intestinal tumors, such as gastrointestinal stromal tumors.\n\nRAS mutation status not tested. Tumor tissue tested by immunohistochemistry as dMMR, or by PCR or NGS as MSI-H. Metastatic lesions are resectable, or the patient wishes to undergo metastasectomy.\n\nUncontrolled active bleeding from the primary tumor or intestinal obstruction. Contraindications to immune checkpoint inhibitor therapy. Hypersensitivity to study drugs or their excipients. Prior or concurrent other malignancy, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma.\n\nActive autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); excluding autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone, type I diabetes mellitus treated with stable doses of insulin, vitiligo, or childhood asthma\u002Fallergy that has resolved and requires no intervention in adulthood.\n\nHistory of immunodeficiency, including HIV positivity, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.\n\nHistory of interstitial lung disease or non-infectious pneumonitis. Active pulmonary tuberculosis infection by history or CT scan, or history of active pulmonary tuberculosis infection within 1 year before enrollment, or history of active pulmonary tuberculosis infection more than 1 year prior without adequate treatment.\n\nActive hepatitis B (HBV DNA ≥2000 IU\u002FmL or 10⁴ copies\u002FmL) or hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay).\n\nSevere cardiac, pulmonary, renal, or hepatic dysfunction. Hypertension that cannot be adequately controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).\n\nHistory of psychotropic substance abuse, alcoholism, or drug addiction. Other factors that may affect patient safety or trial compliance as judged by the investigator, such as serious diseases requiring concomitant treatment (including psychiatric disorders), serious laboratory abnormalities, or other family or social factors.",{"count":166,"type":20},40,[168],"PHASE2","Approximately 20-50% of patients with colorectal cancer (CRC) develop distant metastasis after curative surgery, and those with early relapse within one year of completing adjuvant chemotherapy (XELOX or FOLFOX) have a particularly poor prognosis and limited treatment options. Standard second-line therapy with FOLFIRI plus targeted therapy (bevacizumab or cetuximab) often yields suboptimal outcomes in this population. Moreover, over 95% of these patients have pMMR\u002FMSS tumors, which are inherently resistant to immune checkpoint inhibitor monotherapy.\n\nThis phase II, prospective, randomized trial aims to evaluate the efficacy and safety of adding serplulimab, a PD-1 inhibitor, to second-line chemotherapy plus targeted therapy in patients with early-relapse CRC after adjuvant chemotherapy. Eligible patients with pMMR\u002FMSS or MSI-L tumors will be randomly assigned (1:1) to either the experimental arm (serplulimab plus FOLFIRI and targeted therapy) or the control arm (FOLFIRI plus targeted therapy alone). Randomization is stratified by primary tumor location (left vs. right colon), initial disease status (liver-only vs. extrahepatic metastasis), and RAS status (wild-type vs. mutant). A total of 40 patients (20 per arm) will be enrolled using a Pick-the-Winner design.\n\nThe primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), overall survival (OS), R0 resection rate, and safety (NCI-CTCAE v5.0). Exploratory biomarker analyses in tumor tissue and blood (e.g., PD-L1 expression, tumor mutational burden, lymphocyte subsets, cytokines, TCR sequencing, circulating tumor DNA, and gut microbiome) will be performed to identify potential predictors of response and resistance.\n\nThis is the first prospective randomized study specifically targeting early-relapse CRC after adjuvant chemotherapy. The findings will provide high-level evidence on whether adding PD-1 blockade to standard chemo-targeted therapy can improve outcomes in this high-risk, understudied population and may inform future phase III trials.",[171,27],"Colorectal Cancer","2026-05-17",{"date":174,"type":37},"2026-05-22",{"date":176,"type":37},"2026-05-10",{"date":178,"type":20},"2029-09-10",{"name":180,"class":44},"Fudan University",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":192,"conditions":193,"keywords":198,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":45},"100636801","quantification-of-peripheral-blood-inkts-after-allogeneic-stem-cell-transplantation-100636801","NCT07570407","Quantification of Peripheral Blood iNKTs After Allogeneic Stem Cell Transplantation","Standardised Quantification of Invariant NKT Cells Using DryTube Technology and Flow Cytometry in Patients Who Have Undergone Allogeneic Haematopoietic Stem Cell Transplantation.","QiNKT-HSCT","Inclusion Criteria:\n\n* Diagnosis: AML (exlusion of secondary disease)\n* Disease status at time of HSCT: complete remission\n* Karnofsky performance status: ≥80%\n* Source of HSC: PBSC\n\nExclusion Criteria:\n\n* Prior transplant\n* Uncontrolled Malignancy","70 Years",{"count":191,"type":20},75,"The transplantation of allogeneic haematopoietic stem cells (HSCs) can lead to serious complications after transplantation, such as graft-versus-host disease (GvHD), infections and relapse due to immunosuppression. Invariant NKT cells (iNKT cells) play a pivotal role in modulating the immune response and have been demonstrated to be instrumental in the pathogenesis of GvHD, cytomegalovirus (CMV) infection, and relapse. Their levels are associated with the development of these complications. This multicentre study aims to test the feasibility of standardising iNKT cell monitoring and to investigate the association between iNKT cell levels and post-transplant complications.",[194,195,196,27,197],"Allogeneic HSCT","Posttransplant Complications","GvHD","Acute Myeloid Leukemia",[199,200,201,202],"iNKT cells","HSCT","Flow cytometry","Reconsitution","NOT_YET_RECRUITING","2026-04-29",{"date":206,"type":37},"2026-05-06",{"date":208,"type":20},"2026-05-01",{"date":210,"type":20},"2029-01-31",{"name":212,"class":44},"University Hospital Pilsen",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":45},"100586788","phase-2-epcoritamab-in-combination-with-loncastuximab-tesirine-in-relapsedrefractory-large-b-cell-lymphoma-100586788","NCT06919939","Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed\u002FRefractory Large B-cell Lymphoma","Phase 2 Study of Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed\u002FRefractory Large B-cell Lymphoma","EPCOR+LONCA","Inclusion Criteria:\n\n1. Men and women aged 18 years or older at the time of signing informed consent.\n2. Able and willing to sign the informed consent form (ICF).\n3. Ability to comply with the trial protocol.\n4. Relapsed\u002Frefractory (r\u002Fr) large B-cell lymphoma (LBCL) as determined by the local hematopathology laboratory from the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms (Swerdlow et al., 2016):\n\n   1. LBCL or DLBCL, not otherwise specified (NOS)\n   2. High-grade B-cell lymphoma (NOS or double\u002Ftriple hit \\[technically classified in WHO 2016 as high-grade B-cell lymphoma (HGBCL), with Myc and B-cell lymphoma 2 (BCL2) and\u002For B-cell lymphoma 6 (BCL6) translocations\\])\n   3. Transformed from follicular lymphoma, marginal zone lymphoma (MZL), and nodular lymphocyte predominant Hodgkin lymphoma\n   4. Follicular lymphoma stage 3B\n   5. Primary mediastinal B-cell lymphoma previously treated with checkpoint inhibitor Note: Relapsed disease is defined as disease that has recurred ≥6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy or progressed within 6 months (\\\u003C6 months) of completion of therapy.\n5. Participants who have received at least one prior systemic therapy for LBCL including anti-cluster of differentiation 20 (anti-CD20) monoclonal antibody and anthracycline-containing therapy.\n6. Measurable disease by 2014 Lugano Classification. (Participants who have measurable disease, defined as at least 1 bi-dimensionally measurable nodal lesion, defined as \\>1.5 cm in its longest dimension, or at least 1 bi-dimensionally measurable extra nodal lesion, defined as \\>1.0 cm in its longest dimension.)\n7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.\n8. Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors within 72 hs):\n\n   1. Absolute neutrophil count (ANC) ≥ 1.0 × 10\\^9 cells\u002FL\n   2. Hemoglobin ≥8.0 g\u002FdL without blood transfusion in the past week\n   3. Platelet count ≥75 × 10\\^9 platelets\u002FL or ≥ 50 × 10\\^9 platelets\u002FL if bone marrow involvement or splenomegaly\n   4. Total bilirubin ≤1.5 × upper limit normal (ULN). Participants with documented history of Gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible (≤3x institutional ULN if lymphoma involvement of the liver).\n   5. Alanine transaminase (ALT)\u002Faspartate aminotransferase (AST) ≤3.0 × ULN or ≤5 × ULN in the presence of liver involvement by lymphoma.\n\n      * i. Creatinine within normal institutional limits, or calculated creatinine clearance ≥40 mL\u002Fmin by the Cockcroft-Gault Equation or other institutional standard methods\n9. Willingness to avoid pregnancy during the trial and for at least 12 months after the last dose of the trial intervention.\n10. Patients with history of human immunodeficiency virus (HIV) are eligible, provided they are stable on anti-retroviral therapy, have cluster of differentiation 4 (CD4) count ≥200\u002FµL, and have an undetectable viral load. Note: HIV test is optional.\n11. Life expectancy of at least 12 weeks\n12. For patients receiving glucocorticoid treatment at screening: treatment must be tapered down and administered with a maximum of 25 mg daily in the last 14 days before the first dose of epcoritamab.\n\nExclusion Criteria:\n\n1. Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma at screening as confirmed by magnetic resonance imaging (MRI)\u002Fcomputed tomography (CT) scan (brain) and, if clinically indicated, by lumbar puncture.\n2. Prior treatment with anti-cluster of differentiation 19 (anti-CD19) chimeric antigen receptor T-cell (CAR-T) therapy\n3. Prior exposure to bispecific T-cell engaging antiCD20XCD3 antibodies\n4. Prior autologous or allogenic stem cell transplant\n5. Known clinically significant pulmonary disease, including:\n\n   1. Pulmonary fibrosis affecting patient's exercise tolerance.\n   2. Chronic obstructive pulmonary disease (COPD) affecting patient's exercise tolerance.\n6. Known clinically significant cardiac disease, including:\n\n   1. Onset of unstable angina pectoris within 6 months of signing ICF\n   2. Acute myocardial infarction within 6 months of signing ICF\n   3. Congestive heart failure (grade III or IV as classified by the New York Heart Association\n7. Pregnant or breast feeding\n8. Inadequate recovery from toxicity and\u002For complications from a major surgery before starting therapy.\n9. Chronic or current active infectious disease (including severe acute respiratory syndrome (SARS) coronavirus 2 (CoV-2) requiring systemic antibiotics, antifungal, or antiviral treatment or any major episode of infection requiring treatment with intravenous (IV) antibiotics within 2 weeks of Day 1 of Cycle 1.\n10. Exposure to a live vaccine within 30 days of administration or anticipation that a live attenuated vaccine will be required during the study.\n\n    1. Inactivated influenza vaccinations may be given during the influenza season.\n    2. An approved coronavirus disease 2019 (COVID-19) vaccine (messenger ribonucleic acid (mRNA), inactivated virus, and replication deficient viral vector vaccines) is allowed.\n11. Active hepatitis B infection\n\n    a. Patients who are hepatitis B surface antigen (HbsAg) negative and hepatitis B core antibody (HbcAb) positive must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR) to be eligible for study participation\n12. Active hepatitis C infection\n\n    a. Patients who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by PCR to be eligible for study participation\n13. Patient has no known active SARS-CoV-2 infection. If a subject has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection, the patient must have a negative molecular (eg, PCR) test or 2 negative antigen test results at least 24 hours apart.\n\n    Note: SARS-CoV-2 diagnostic tests should be applied following local requirements\u002Frecommendations. Patients who do not meet SARS-CoV-2 infection eligibility criteria must be screen-failed and may only rescreen if the following have been met:\n    * At least 10 days since first positive test result have passed in asymptomatic patients or at least 10 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms.\n14. Patients with severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the patient's ability to tolerate the study treatment.\n15. Patients with seizure disorder requiring therapy with a last convulsion within two years from enrollment.\n16. Patients with impaired decision-making capacity.",{"count":222,"type":20},26,[168],"The purpose of this study is to determine whether combining Loncastuximab Tesirine with Epcoritamab is tolerable and effective for reducing and\u002For eliminating lymphoma cells in the body.",[226,27],"Large B-cell Lymphoma","2026-02-26",{"date":229,"type":37},"2026-03-02",{"date":231,"type":37},"2026-01-07",{"date":233,"type":20},"2031-01-07",{"name":235,"class":44},"University of Miami",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":189,"enrollmentInfo":243,"targetDuration":245,"studyType":140,"phases":4,"briefSummary":246,"conditions":247,"keywords":254,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":45},"100627418","eus-guided-ctcs--multi-omics-predicting-pancreatic-cancer-recurrence-and-metastases-100627418","NCT07448376","EUS-guided CTCs + Multi-omics: Predicting Pancreatic Cancer Recurrence and Metastases","Exploratory Study on EUS-guided Portal Vein CTCs and Their Subtypes Combined With Multi-omics Detection for Early Warning of Pancreatic Cancer Recurrence and Metastasis","Inclusion Criteria:\n\n1. Patients with solid masses (diameter \\> 1 cm) in the pancreatic area within the accessible range of endoscopic ultrasound, as indicated by clinical symptoms, laboratory tests, and imaging examinations (MRI, CT, B-ultrasound), who require biopsy to clarify the nature of the lesion.\n2. Patients diagnosed with resectable pancreatic cancer, borderline resectable pancreatic cancer, locally advanced pancreatic cancer by imaging(CT\u002FMRI).\n3. Newly diagnosed pancreatic cancer patients who have not received radiotherapy or chemotherapy.\n4. Signed informed consent form.\n5. Patients must be able to comply with the trial requirements.\n\nExclusion Criteria:\n\n1. Patients with other active malignant tumors\n2. Patients with coagulation dysfunction (PLT 50,000\u002Fmm3, INR \\> 1.5; roughly estimated, INR \\> 1.5 is approximately equivalent to PT \\> 18 seconds)\n3. Pregnant women\n4. Patients with hemorrhagic diseases\n5. Patients with a history of taking anticoagulant drugs such as aspirin and warfarin in the past week\n6. Patients with absolute contraindications to EUS examination, a history of acute pancreatitis within the past 2 weeks, a history of gastric surgery, pregnancy, severe diseases, or a history of allergy to anesthetics\n7. Patients whose EUS examination was terminated early due to esophageal stenosis, obstruction, large space-occupying lesions, rapid changes in the patient's heart rate or respiratory rate, patient intolerance, or a large amount of food residue, etc.\n8. Patients with known hepatitis C virus infection\n9. Patients with known human immunodeficiency virus (HIV) infection\n10. Patients with imaging examinations, EUS results, etc., suggesting pancreatic cystic space-occupying lesions\n11. Patients who have received radiotherapy or chemotherapy\n12. Patients with incomplete pathological information, unable to make a clear diagnosis, or unable to sign the informed consent form",{"count":244,"type":20},20,"2 Years","The investigators conduct a single-center, prospective, observational study to explore the value of EUS-guided portal vein circulating tumor cells (PV-CTCs) and their subtypes combined with multi-omics tests in the early warning of recurrence and metastasis of resectable pancreatic cancer(RPC) and borderline resectable pancreatic cancer (BRPC).",[248,249,250,27,251,252,253],"CTCs","Pancreatic Cancer","Liver Metastases","Borderline Resectable Pancreatic Cancer","Resectable Pancreatic Cancers","EUS",[253,255,249,256,257,258,259],"CTC","metastases","relapse","BRPC","RPC","2026-02-25",{"date":262,"type":37},"2026-03-04",{"date":264,"type":20},"2026-03-01",{"date":266,"type":20},"2027-12-30",{"name":268,"class":44},"Huazhong University of Science and Technology",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":21,"phases":278,"briefSummary":279,"conditions":280,"keywords":284,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":45},"100523465","phase-1-autologous-car-t-cells-targeting-cspg4-in-relapsedrefractory-hnscc-100523465","NCT06096038","Autologous CAR-T Cells Targeting CSPG4 in Relapsed\u002FRefractory HNSCC","Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study:\n\n1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by and signed by the subject; subject given a copy of the informed consent form.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60%\n4. Histologically or cytologically confirmed stage recurrent\u002Fmetastatic squamous cell carcinoma of the head and neck as defined by American Joint Committee on Cancer (AJCC). This includes squamous cancer of: oral cavity, oropharynx, hypopharynx and larynx.\n\nExclusion Criteria:\n\n1. Subject with a history or current severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, uncontrolled arrhythmia, or myocardial infarction in the past 6 months.\n2. Subject with a history of stroke or transient ischemic attack (TIA) within 12 months before procurement.\n3. Subject with a history of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.",{"count":277,"type":20},33,[23,168],"The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen (iC9.CAR-CSPG4 T cells) in patients with head and neck cancer that came back after receiving standard therapy for this cancer. The iC9.CAR-CSPG4 treatment is experimental and has not been approved by the Food and Drug Administration.\n\nHow many (dose) of the iC9.CAR. CSPG4 T cells are safe to use in patients without causing too many side effects, and what is the maximum dose that could be tolerated will be investigated. The information collected from the study would help cancer patients in the future.\n\nThere are two parts to this study. In part 1, blood will be collected to prepare the iC9.CAR-CSPG4 T cells. Disease fighting T cells will be isolated and modified to prepare the iC9.CAR-CSPG4 T cells. In part 2, the iC9.CAR-CSPG4 T cells are given by infusion after completion of lymphodepletion chemotherapy.\n\nThe data from the dose escalation will be used to determine a recommended phase 2 dose (RP2D), which will be decided based on the maximum tolerated dose (MTD). Additionally, recommended phase 2 dose will be tested.\n\nEligible subjects will receive lymphodepletion chemotherapy standard followed by infusion of iC9-CAR.CSPG4 T cells. After treatment completion or discontinuation, subjects will be followed since involving gene transfer experiments.",[281,27,282,283],"Head and Neck Cancer","Recurrent","Refractory Cancer",[31],"2026-02-18",{"date":287,"type":37},"2026-02-20",{"date":289,"type":37},"2024-04-05",{"date":291,"type":20},"2028-08-01",{"name":43,"class":44},{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":21,"phases":303,"briefSummary":304,"conditions":305,"keywords":308,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":316,"locationsCount":45},"100615025","phase-1-the-safety-and-efficacy-of-daratumumab-in-patients-with-refractory-aplastic-anemia-100615025","NCT07287228","The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia","An Ib\u002FII Phase Clinical Study Evaluating the Safety and Preliminary Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia","DARA-AA-001","Inclusion Criteria:\n\n1. Clearly diagnosed with primary acquired aplastic anemia according to the Chinese Guidelines for the Diagnosis and Treatment of Aplastic Anemia (2022 Edition).\n2. Refractory aplastic anemia meeting one of the following criteria:\n\n   2.1 Patients previously diagnosed with severe aplastic anemia (SAA) # or transfusion-dependent non-severe aplastic anemia (TD-NSAA) \\&: have received antithymocyte\u002Fantilymphocyte globulin (ATG\u002FALG) combined with standard-dose cyclosporine for at least 6 months, and standard-dose thrombopoietin (TPO) receptor agonist\\* therapy for at least 4 months, but showed no response or relapsed; 2.2 Patients previously diagnosed with non-transfusion-dependent non-severe aplastic anemia (NTD-NSAA): have received standard-dose cyclosporine for at least 6 months, and standard-dose thrombopoietin (TPO) receptor agonist\\* therapy for at least 4 months, but showed no response or relapsed.\n3. Hemoglobin \\\u003C90 g\u002FL or platelet count \\\u003C30×10⁹\u002FL.\n4. Not suitable for or unwilling to undergo hematopoietic stem cell transplantation; no other better treatment options available.\n5. Age ≥18 years, no sex limitation.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2 (see Appendix 2).\n7. Voluntarily signed the informed consent form, understands the nature, purpose, and procedures of the trial, and is willing to comply with the trial requirements.\n\nExclusion Criteria:\n\n1. Patients with congenital bone marrow failure syndromes.\n2. Patients with bone marrow reticulin staining ≥ Grade 2.\n3. Patients with paroxysmal nocturnal hemoglobinuria (PNH) clone ≥50% or with active hemolysis.\n4. Patients with clonal chromosomal abnormalities characteristic of myelodysplastic syndrome (MDS) (except +8, 20q-, and -Y).\n5. Presence of active bacterial, viral, or fungal infection within 2 weeks prior to the first administration of the investigational drug (excluding common cold and onychomycosis), or any other severe infection. Any anti-infective therapy for infections must be completed at least 2 weeks before the first dose. History of HIV infection or HIV antibody positive during screening; positive treponema pallidum antibody during screening; active pulmonary tuberculosis (evidenced by chest imaging or other relevant examinations within 3 months prior to first administration or during screening indicating active TB infection); active hepatitis during screening (positive hepatitis B surface antigen \\[HBsAg\\], or positive hepatitis B core antibody \\[HBcAb\\] with HBV DNA ≥30 IU\u002FmL, or positive hepatitis C antibody \\[HCV Ab\\] with positive HCV RNA).\n6. Presence of active bleeding in the gastrointestinal tract, respiratory tract, central nervous system, or other sites.\n7. History of significant clinical diseases that, in the investigator's judgment, would pose a safety risk for the subject's participation or affect the evaluation of efficacy or safety if the disease\u002Fcondition worsens during the study. Examples include:\n\n   7.1 Cardiovascular disease: acute myocardial infarction or unstable angina within the past year, severe arrhythmias (such as frequent multifocal PVCs, ventricular tachycardia, ventricular fibrillation, etc.), congestive heart failure, arterial or venous thrombosis, NYHA Class III-IV cardiac function.\n\n   7.2 History of psychiatric disorders or severe cerebrovascular disease or cognitive sequelae.\n8. Use of B-cell or plasma-cell targeting agents within 3 months prior to the first administration of the investigational drug or expected use during the study period.\n9. Receipt of antithymocyte globulin or antilymphocyte globulin within 6 months prior to the first administration of the investigational drug.\n10. Treatment with tacrolimus, sirolimus, cyclophosphamide, anti-CD52 monoclonal antibodies, or similar agents within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration of the investigational drug.\n11. Planned participation in another clinical trial or prior exposure to another investigational product within less than 4 weeks or 5 half-lives (whichever is shorter) before the first dose.\n12. Vaccination with live attenuated vaccines within 4 weeks prior to the first administration of the investigational drug or planned during the study period, or COVID-19 vaccination within 7 days prior to first administration.\n13. Prior exposure to CD38-targeted therapy.\n14. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study; female subjects of childbearing potential and male subjects with partners of childbearing potential who are unwilling to use highly effective contraception (see Appendix 3 for specific methods) throughout the study (from signing the ICF to 6 months after the last dose of study drug), or who plan to donate eggs or sperm during the study.\n15. Any other conditions deemed unsuitable for participation in this study by the investigator.",{"count":302,"type":20},37,[23,168],"This study consists of two phases, phase Ib and phase II. The primary objective of phase Ib is to evaluate the safety and tolerability of multiple doses of daratumumab in patients with refractory aplastic anemia. The primary objective of phase II is to preliminarily assess the efficacy of multiple doses of daratumumab in patients with refractory aplastic anemia. Secondary objectives include evaluation of other efficacy endpoints, safety (phase II), and pharmacodynamic characteristics of multiple doses of daratumumab in these patients. The exploratory objective is to assess biological functional changes in peripheral blood and bone marrow before and after daratumumab treatment.",[306,307,27],"Aplastic Anemia","Refractory",[309],"Aplastic anemia, Daratumumab","2025-12-16",{"date":312,"type":37},"2025-12-17",{"date":314,"type":20},"2025-12-10",{"date":155,"type":20},{"name":317,"class":44},"Institute of Hematology & Blood Diseases Hospital, China",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":21,"phases":327,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":45},"100523072","phase-1-atlcarcd30ccr4-for-cd30-hl-atlcarcd30ccr4-cells-100523072","NCT06090864","ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells","The Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) and CCR4 for Relapsed\u002FRefractory CD30+ Hodgkin s Lymphoma","During the period of cell procurement and lymphodepletion, subjects will be eligible to receive standard-of-care therapy e.g., chemotherapy or radiation therapy to stabilize their disease if the treating physician feels it is in the subject's best interests. Eligibility must be maintained up until the subject is procured, receives lymphodepletion, or receives treatment for the subject to be considered eligible to proceed with the specific phase of the study.\n\nInclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study. As these criteria are unchanging they will be evaluated at the time of initial enrollment and not continuously throughout the study.\n\n1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by, and signed by the subject or legally authorized representative.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60%\n4. The subject must have a diagnosis of Classical Hodgkin Lymphoma according to World Health Organization criteria.\n\nExclusion Criteria:\n\n1. Subjects had major surgery within 28 days.\n2. Subject received investigational agents or tumor vaccines within 3 weeks.\n3. Subject received chemotherapy or radiation therapy within the previous 3 weeks.",{"count":326,"type":20},31,[23,168],"Despite the progress in the therapy, Hodgkin's Lymphoma (HL) remains fatal for more than 15% of patients. Even in patients who are cured, the morbidity of therapy is substantial and long-lasting. New therapeutic agents are required therefore not only to further reduce mortality but also to alleviate morbidity.\n\nThe majority of HL express the CD30 antigens. CD30 expression is routinely used for the diagnosis of HL. Preclinical observations support CD30 as a viable target of CAR-T therapy. This phase Ib\u002FII study was conducted based on these observations.\n\nThe purpose of this study is to determine the tolerability of ATLCAR.CD30.CCR4 cells in subjects with Hodgkin's Lymphoma and identify a recommended dose for further.\n\nThis is a single-center, open-label phase Ib\u002FII trial that uses a 3+3 design to identify a recommended phase 2 dose (RP2D) of ATLCAR.CD30.CCR4 cells in Hodgkin's Lymphoma. The phase II portion is designed to determine the PFS of ATLCAR.CD30.CCR4 in Hodgkin's Lymphoma.\n\nSubjects will be enrolled on 1 of 3 dose levels as determined by a 3+3 design. Up to 25 evaluable subjects may then be enrolled in the phase II portion of the study. Subjects may have cells procured to manufacture the ATLCAR.CD30.CCR4 cells if they meet eligibility for procurement. During the time period necessary to manufacture the ATLCAR.CD30.CCR4 cells, Subjects will be allowed to receive standard-of-care bridging therapy at the discretion of their local oncologist. Prior to cell infusion, subjects will undergo additional eligibility evaluations, and then if eligible, will undergo lymphodepletion followed by cell infusion 2-14 days later. Subjects will then be followed for 15 years as is required for studies involving gene transfer experiments.",[330,27,307],"Hodgkin Lymphoma",[31,332],"CD30+","2025-10-16",{"date":335,"type":37},"2025-10-20",{"date":337,"type":37},"2024-04-25",{"date":339,"type":20},"2031-07-01",{"name":43,"class":44},{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":21,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":45},"100543516","phase-2-intraarterial-carboplatin--caelyx-vs-intraarterial-carboplatin--etoposide-phosphate-for-progressing-glioblastoma-100543516","NCT06356883","Intraarterial Carboplatin + Caelyx vs Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma","A Randomized Phase II Study on Intraarterial Carboplatin Combined With Caelyx Compared to Intraarterial Carboplatin Combined With Etoposide Phosphate for Progressing Glioblastoma at First or Second Relapse","Inclusion Criteria:\n\n1. Histological diagnosis of glioblastoma multiforme.\n2. Radiological progression on an MRI scan, according to the RANO criteria, in the context of a known glioblastoma multiforme, already treated with the Stupp protocol of combined radiotherapy-Temozolomide. This implies a measurable disease on MRI.\n3. Prior radiotherapy and temozolomide, as per the Stupp protocol, no sooner than 4 weeks, is permitted.\n4. Eighteen or more years of age.\n5. Performance status: Karnofsky ranging from 60 to 100%.\n6. Haematopoietic parameters at recruitment:\n\n   * Platelet counts \\> 100,000\u002Fmm3.\n   * Hemoglobin \\> 8 g\u002FdL.\n   * Absolute neutrophil count \\> 1,500\u002Fmm3.\n7. No impaired bone marrow function.\n8. Hepatic parameters at recruitment:\n\n   * Bilirubin ≤ 2 times normal value.\n   * AST and ALT ≤ 2 times upper limit of normal (ULN).\n   * Alkaline phosphatase ≤ 2 times ULN (unless attributed to the tumour).\n   * No impaired hepatic function.\n9. Renal parameters at recruitment:\n\n   * No impaired renal function.\n   * Creatinine no greater than 1.5 fold of the normal value.\n   * Creatinine clearance \\> 30 ml\u002Fmin.\n10. Normal ECG.\n11. Written informed consent obtained.\n\n    * Patients should be either sterile or else use a contraceptive strategy (for at least 2 months prior to study accruals).\n\nExclusion Criteria:\n\n1. Presence of a severe psychiatric or medical condition that would interfere with treatment administration or study recruitment.\n2. Presence of an active autoimmune disease.\n3. No prior cardiac disease within the past 5 years OR LVEF of at least 50% at baseline ultrasound.\n4. Occurrence of another malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or in situ cervical carcinoma.\n5. Pregnancy (as confirmed by a positive b-HCG) or actively nursing.\n6. Presence of an uncontrolled systemic infection.",{"count":349,"type":20},120,[168],"The standard of care for glioblastoma (GBM) treatment involves maximal resection followed by concomitant radiotherapy and temozolomide. Progression-free survival (PFS) with this treatment is only 6.9 months and relapse is inevitable. At relapse, there is no consensus regarding the optimal therapeutic strategy. The rationale behind the fact that limited chemotherapy agents are available in the treatment of malignant gliomas is related to the blood-brain barrier (BBB), which impedes drug entry to the brain. Intraarterial (IA) chemotherapy allows to circumvent this. Using IA delivery of carboplatin, can produce responses in 70% of patients for a median PFS of 5 months. Median survival from study entry was 11 months, whereas the overall survival (OS) 23 months. How can the OS and PFS be improved? By combining chemotherapeutic agents with different mechanisms of action.\n\nStudy design: In this phase II trial, treatment will be offered at relapse. Surgery will be performed for cytoreduction if it is warranted, followed with a combination IA carboplatin + IA Cealyx (liposomal doxorubicin) or IA carboplatin + IA etoposide phosphate. Toxicity will be assessed according to the NCIC common toxicity criteria. Treatment will consist in either IA carboplatin (400 mg\u002Fm\\^2) + IA Cealyx (30 mg\u002Fm\\^2) or IA carboplatin (400 mg\u002Fm\\^2) + IA etoposide phosphate (400 mg\u002Fm\\^2) every 4-6 weeks (1 cycle). Up to twelve cycles will be offered.\n\nOutcome measurements: Tumor response will be evaluated using the RANO criteria by magnetic resonance imaging monthly. Primary outcome will PFS and tumor response. Secondary outcome will include median OS, toxicity, quality of life (QOL), neurocognition (NC).\n\nPutting together these data will allow to correlate clinical and radiological response to QOL and NC.",[353,27],"Glioblastoma Multiforme","2025-08-05",{"date":356,"type":37},"2025-08-07",{"date":358,"type":20},"2025-08",{"date":360,"type":20},"2028-04",{"name":362,"class":44},"Université de Sherbrooke",{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":21,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":45},"100337382","phase-1-ia-carboplatin--radiotherapy-in-relapsing-gbm-100337382","NCT03672721","IA Carboplatin + Radiotherapy in Relapsing GBM","A Phase II Study in Relapsing Glioblastoma of Intraarterial Concurrent Chemoradiation Therapy Using IA Carboplatin","Inclusion Criteria:\n\n1. Histological diagnosis of glioblastoma multiforme\n2. Radiological progression on an MRI scan, according to the RANO criteria, in the context of a known glioblastoma multiforme, already treated with the Stupp protocol of combined radiotherapy-Temozolomide, and progressing. This implies a measurable disease on MRI.\n3. Prior radiotherapy and temozolomide, as per the Stupp protocol, no sooner than 4 weeks, is permitted.\n4. 18 of age and over\n5. Performance status: Karnofsky 60-100%\n6. Haematopoietic parameters at enrolment:\n\n   * Platelet counts \\> 100,000\u002Fmm\\^3\n   * Hemoglobin \\> 8 g\u002FdL\n   * Absolute neutrophil count \\> 1,500\u002Fmm\\^3\n   * No impaired bone marrow function\n7. Hepatic parameters at enrolment:\n\n   * Bilirubin ≤ 2 times normal value\n   * AST and ALT ≤ 2 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN (unless attributed to tumor)\n   * No impaired hepatic function\n8. Renal parameters at enrollment:\n\n   * No impaired renal function\n   * Creatinine no greater than 1.5 fold of the normal value\n   * Creatinine clearance \\> 30 ml\u002Fmin.\n9. Normal ECG\n10. Written informed consent obtained\n11. Patient should be either sterile or else use a contraceptive strategy (for at least 2 months prior to study accrual).\n\n    \\-\n\nExclusion Criteria:\n\n1. Presence of a severe psychiatric or medical condition that would interfere with treatment administration or study enrolment.\n2. Presence of an active auto-immune disease.\n3. Occurrence of another malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n4. Pregnancy (as objectivated by a positive b-HCG) or actively nursing\n5. Presence of an uncontrolled systemic infection",{"count":371,"type":20},35,[23,168],"Treatment of glioblastoma involves an optimal surgery, followed by a combination of radiation and temozolomide chemotherapy. Progression-free survival (PFS) with this treatment is only 6.9 months and relapse is the norm. The rationale behind the fact that limited chemotherapy agents are available in the treatment of malignant gliomas is related to the blood-brain barrier (BBB), which limits drug entry to the brain. Intraarterial (IA) chemotherapy allows to circumvent this. Using IA delivery of carboplatin, the investigators have observed responses in 70% of patients for a median PFS of 5 months. Median survival from study entry was 11 months, whereas the overall survival 23 months. How can this be improved? By coupling radiation with a chemotherapeutic which is also a potent radiosensitizer such as carboplatin.\n\nStudy design: In this phase I\u002FII trial, patients will be treated at recurrence; a surgery will be performed for cytoreduction and to obtain tumor sample, followed with a combination of re-irradiation and IA carboplatin chemotherapy. A careful escalation scheme from 1.5Gy\u002Ffraction up to 3.5Gy\u002Ffraction will allow the investigators to determine the optimal re-irradiation dose (10 fractions of radiation over 2 weeks). Toxicity will be assessed according to the NCIC common toxicity criteria. Combined with radiation, patients will receive 2 treatments of IA carboplatin, 400 mg\u002Fm2, 4 hours prior to the first and the sixth radiation fraction. IA treatments will then be continued on a monthly basis, up to a total of 12 months, or until progression.\n\nOutcome measurements: Tumor response will be evaluated using the RANO criteria by magnetic resonance imaging monthly. The investigators will also acquire a sequence that enables the measurement of cerebral blood flow, cerebral blood volume and blood vessel permeability that are all relevant to understand the delivery of therapeutics to the CNS. Primary outcome will be OS and PFS. Secondary outcome will be QOL, neurocognition, and carboplatin delivery.\n\nIn vitro intracellular carboplatin accumulation: Tumor samples from re-operation will be be analyzed for intracellular Pt concentration by ICP-MS. The amount of Pt bound to DNA will be measured. The level of apoptosis will be determined for each of the sample.\n\nPutting together these data will allow to correlate clinical and radiological response to QOL, NC (MOCA), and to delivery surrogates for the IA infusion and intracellular penetration of carboplatin.",[353,27],{"date":376,"type":37},"2025-08-11",{"date":378,"type":37},"2018-07-10",{"date":380,"type":20},"2026-06-10",{"name":362,"class":44},{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":389,"maxAge":390,"enrollmentInfo":391,"targetDuration":4,"studyType":21,"phases":392,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":405,"leadSponsor":407,"locationsCount":45},"100601060","phase-2-effectiveness-and-safety-of-blinatumomab-and-donor-lymphocyte-infusion-in-maintenance-therapy-after-allogeneic-hematopoietic-stem-cell-transplantation-for-high-risk-ph-negative-b-cell-acute-lymphoblastic-leukemia-100601060","NCT07105579","Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia","Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia：Phrase II, Exploratory Study","Inclusion Criteria:\n\n1. Age 14-65 years (inclusive), regardless of gender.\n2. Newly diagnosed B-ALL with CD19 expression on leukemic cells (regardless of CD19 positivity rate).\n3. Ph-negative B-ALL with high-risk features post-allo-HSCT .\n4. ≥2 months post-transplant with hematopoietic reconstitution.\n5. Bone marrow morphology in remission and MRD-negative before enrollment.\n6. ECOG performance status \\\u003C3 and Karnofsky score ≥70.\n7. No history of grade III\u002FIV graft-versus-host disease (GVHD) and no active GVHD at enrollment.\n8. Adequate organ function:AST and ALT ≤3× upper limit of normal (ULN), total bilirubin ≤2×ULN.Serum creatinine ≤2×ULN or creatinine clearance ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula).Left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO).\n9. Expected survival \\>3 months.\n10. Voluntary provision of written informed consent, with ability to understand and comply with study requirements.\n\nExclusion Criteria:\n\n1. History of hypersensitivity or severe adverse reactions to the study drug or structurally similar compounds, as assessed by the investigator to preclude participation.\n2. Pregnant or lactating women, or women of childbearing potential unwilling to use effective contraception.\n3. Severe cardiac dysfunction, including:Left ventricular ejection fraction (EF) \\\u003C60%.Clinically significant arrhythmias (e.g., ventricular tachycardia, atrial fibrillation, second-degree heart block).Prolonged QTc interval (men \\>450 ms; women \\>470 ms).Myocardial infarction within the past year.Symptomatic coronary artery disease requiring medication.\n4. Severe pulmonary dysfunction (obstructive and\u002For restrictive ventilatory impairment).\n5. Severe hepatic impairment:ALT or total bilirubin (TBIL) \\>3× upper limit of normal (ULN).\n6. Severe renal impairment:Serum creatinine (Cr) \\>2× ULN.24-hour creatinine clearance (Ccr) \\\u003C50 mL\u002Fmin.\n7. Active infection or uncontrolled bleeding, as assessed by the investigator to preclude safe administration of the study drug.\n8. History of thrombosis, embolism, cerebral hemorrhage, or other significant vascular events within the past year.\n9. Psychiatric disorders or other conditions that impair the ability to provide informed consent or comply with study procedures.\n10. Major organ surgery within the past six weeks.\n11. Drug abuse or chronic alcoholism that may interfere with study assessments.\n12. Prior organ transplantation (excluding hematopoietic stem cell transplantation).\n13. Other conditions deemed by the investigator to make the patient unsuitable for participation.","14 Years","65 Years",{"count":326,"type":20},[168],"A single-arm trial to evaluate the effectiveness and safety of Blinatumomab and Donor Lymphocyte Infusion in maintenance therapy after allogeneic hematopoietic stem cell transplantation for high-risk Ph negative B cell acute lymphoblastic leukemia",[395,27],"Leukemia",[397,398,399,400],"hematopoietic stem cell transplantation","Blinatumomab","Donor Lymphocyte Infusion","Ph negative B cell Acute Lymphoblastic Leukemia","2025-08-04",{"date":403,"type":37},"2025-08-06",{"date":358,"type":20},{"date":406,"type":20},"2027-12-31",{"name":408,"class":44},"First Affiliated Hospital of Zhejiang University",{"id":410,"slug":411,"hasResults":11,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":21,"phases":419,"briefSummary":420,"conditions":421,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":45},"100563940","phase-1-cd7-car-t-cells-rd13-02-in-the-treatment-of-relapsedrefractory-severe-aplastic-anemia-100563940","NCT06622694","CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed\u002FRefractory Severe Aplastic Anemia","A Clinical Study of Safety, Efficacy, and Pharmacokinetics of Universal CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed\u002FRefractory Severe Aplastic Anemia","Inclusion Criteria:\n\n* Willing and able to provide written informed consent.\n* Age ≥18 years and ≤75 years.\n* Diagnosed with severe aplastic anemia: Diagnostic criteria refer to the UK Hematology Guidelines (Br J Haematol, 2024, 204(3): 784-804): 1) Bone marrow cellularity \\\u003C25% (or 25-50% but \\\u003C30% residual hematopoietic cell area); 2) At least two of the following conditions must be met: ANC \\\u003C0.5×10\\^9\u002FL, PLT \\\u003C20×10\\^9\u002FL, absolute reticulocyte count \\\u003C60×10\\^9\u002FL; 3) Exclusion of other congenital or acquired hematopoietic failure disorders.\n* Had at least one course of standard-dose therapy with anti-thymocyte globulin (ATG) or anti-lymphocyte globulin (ALG) combined with TPO-RA that was ineffective or relapsed after remission within the past 6 months.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Willing and able to comply with the study procedures.\n\nExclusion Criteria:\n\n* Blood cell reduction and hypoplastic bone marrow diseases due to other causes (e.g., hemolytic PNH, hypoplastic MDS\u002FAML, antibody-mediated pancytopenia).\n* Received ATG\u002FALG treatment less than 6 months ago; received TPO-RA treatment less than 4 months ago. Note: Patients on stable doses of cyclosporine or hematopoietic agents at screening can be enrolled if laboratory values are stable.\n* Significant neurological disease history, including dementia, stroke without paralysis, aphasia, seizures, or any neurological history that may pose safety risks regarding cell therapy as judged by the investigator.\n* History of allogeneic bone marrow or stem cell transplantation, or solid organ transplantation (e.g., kidney, lung, heart), or plans for such transplantation in the future.\n* History of autologous or allogeneic CAR T therapy.\n* Any primary immunodeficiency disease.\n* Significant cardiovascular dysfunction history or current significant cardiovascular dysfunction, particularly:\n* Signs or symptoms of congestive heart failure classified as NYHA class ≥III within 12 months prior to enrollment.\n\n  1. Echocardiogram showing left ventricular ejection fraction (LVEF) \\\u003C45% (assessed during screening).\n  2. History of any serious arrhythmia, currently on treatment for arrhythmias, significant history of myocardial infarction, clinically significant valvular heart disease (including mild or greater aortic regurgitation or moderate or greater mitral regurgitation), recurrent syncope, or significant hypercoagulable vascular events (e.g., transient ischemic attack or stroke); history of pulmonary embolism.\n* Liver or lung dysfunction, defined as:\n\n  1. Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≥2.5× the upper limit of normal (ULN);\n  2. Total bilirubin ≥1.5×ULN, except in subjects with Gilbert's syndrome.\n  3. Pulmonary hypertension, including secondary pulmonary hypertension, classified as WHO functional class \\>2.\n* Males with QTcF \\>450 msec; females with QTcF \\>470 msec, based on a single ECG or the average of three repeat ECGs taken more than 3 minutes apart.\n* History of malignancy, excluding adequately treated or surgically removed non-melanoma skin cancer or in situ cancers (e.g., cervical cancer, bladder cancer, breast cancer) without residual disease.\n* Pregnant or breastfeeding females, or females planning to become pregnant during the study or within 12 months after RD13-02 infusion.\n* History or signs of significant chronic active or recurrent infections, or significant chronic active or recurrent infections requiring antibiotics, antivirals, or antifungal treatments based on screening laboratory results.\n* Uncontrolled infections at screening. Patients with uncomplicated urinary tract infections (UTIs) and uncomplicated bacterial pharyngitis responding to active treatment may be included with investigator and medical monitor approval.\n* Positive screening for HBsAg, HCV RNA, or HIV. If a subject is HBsAg negative but HBcAb positive, hepatitis B virus DNA testing should be performed; subjects with positive hepatitis B virus DNA should be excluded from the study.\n* Vaccination with live attenuated vaccines within 4 weeks prior to enrollment, or plans to receive live attenuated vaccines during the study.\n* PT, APTT, or INR \\>1.2×ULN, except for subjects on stable doses of anticoagulants who can discontinue treatment prior to using intravenous access procedures.\n* eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m² calculated using the CKD-EPI formula; if eGFR ≥30 mL\u002Fmin\u002F1.73 m² but \\\u003C45 mL\u002Fmin\u002F1.73 m², adjust fludarabine dosing in the lymphodepleting regimen based on renal function.\n* History of drug or alcohol abuse within the past year.\n* Currently enrolled in other experimental device or drug studies, or less than 30 days since ending other experimental device or drug interventions, or less than 5 half-lives (whichever is longer).\n* History of hypersensitivity or life-threatening reactions to any component or formulation of the study drug or treatment (including lymphodepleting regimen). For detailed information about study drug components, refer to the investigator brochure (IB).\n* Any condition the investigator believes may affect participation, pose safety risks to the subjects, or potentially confound the interpretation of study results.","75 Years",{"count":418,"type":20},15,[23],"This trial is exploratory research aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD13-02, a universal CD7 CAR T therapy, in subjects with relapsed\u002Frefractory severe aplastic anemia (SAA)",[422,27,307,423],"Severe Aplastic Anemia","CAR T-cell Therapy","2025-07-23",{"date":426,"type":37},"2025-07-24",{"date":428,"type":37},"2025-06-19",{"date":430,"type":20},"2026-12-31",{"name":317,"class":44},{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":16,"minAge":389,"maxAge":439,"enrollmentInfo":440,"targetDuration":4,"studyType":21,"phases":442,"briefSummary":443,"conditions":444,"keywords":447,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":45},"100568813","phase-2-demethylating-agents-combined-with-venetoclax-for-high-risk-t-cell-lymphoblastic-lymphomaleukemia-post-transplant-relapse-prevention-100568813","NCT06686108","Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma\u002FLeukemia Post-Transplant Relapse Prevention","Safety and Efficacy Study of Demethylating Agents With Venetoclax in Preventing Recurrence of High-risk T-cell Lymphoblastic Lymphoma\u002FLeukemia After Transplantation","Inclusion Criteria:\n\n* 1.14-55 years old, male,or female.\n* 2.Patients with allo-HSCT due to T-LBL\u002FALL, the donor type is not limited.\n* 3.ECOG score is 0-2 points.\n* 4.Blood routine: ANC ≥ 1.0 × 109\u002FL, PLT ≥ 50 × 109\u002FL.\n* 5.One of the following high-risk factors:\n* a. Age of initial diagnosis ≥ 35 years old.\n* b. Initial diagnosis of WBC ≥ 100 × 109\u002FL.\n* c. Initial diagnosis of LDH exceeding the upper limit of normal values.\n* d. Initial diagnosis of bone marrow involvement (blast cells ≥ 5%).\n* e. Initial diagnosis of a bulky in the mediastinum (longest diameter ≥ 10cm).\n* f. ETP immunophenotype.\n* g. During the induction chemotherapy process, 2 courses did not achieve partial remission and\u002For 4 courses did not achieve complete remission.\n* h. Residual lesions before transplantation: Flow cytometry analysis showed that the proportion of abnormal lymphoid cells in the bone marrow was greater than 0.01%; Positive detection of minimal residual lesions in molecular biology; PET-CT scan shows that residual lesions are still active.\n* i. Based on the ELN recommendation based on adult T-ALL: gene mutations involving myeloid related genes, RAS\u002FPI3K\u002FAKT, JAK\u002FSTAT signaling pathway, and epigenetics, such as FLT3, NRAS\u002FKRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations; t (8; 14) (q24; q11)\u002FMYC rearrangement; t (7; 19) (q34; p13)\u002FTCR-LYL1，TCR-MEF2C; del(5q) (q14).\n* j. High risk subgroups based on NGS definition: PI3K signaling pathway\u002FNRAS, KRAS\u002FTP53\u002FIKZF1\u002FDNTM3A\u002FIDH1, IDH2 gene mutation with or without NOTCH1, FBXW7\u002FPHF6\u002FEP300 gene mutation.\n\nExclusion Criteria：\n\n* 1.Central involvement during any course of the disease.\n* 2.Patients who have not achieved complete remission before transplantation.\n* 3.Identify those with available targeted drugs.\n* 4.For those who are resistant to BCL-2 inhibitors before transplantation, if the disease progresses during the application process, or if 3-4 courses of induction therapy containing BCL2 inhibitors do not improve.\n* 5.Individuals who are known to be allergic to demethylating drugs or venetoclax.\n* 6.Individuals with grade 2 or more degrees of active acute GVHD.\n* 7.Individuals with moderate to severe chronic GVHD.\n* 8.T-LBL\u002FALL relapse (flow cytometry abnormal lymphocyte cell proportion\\>0.01%, WT1 positive, fusion gene positive, or extramedullary recurrence), or transplant rejection, bone marrow donor cell chimerism\\\u003C95%.\n* 9.Blood routine: ANC\\\u003C1.0 × 109\u002FL or PLT\\\u003C50 × 109\u002FL.\n* 10.Combined with severe organ dysfunction; The ratio of aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) is more than 3 times the normal value or the normal value of direct bilirubin is more than 3 times; The endogenous creatinine clearance rate (Ccr) is less than 50mL\u002Fmin or 1.5 times the normal value of blood creatinine, regardless of whether hemodialysis treatment is used.\n* 11.Merge severe active infections.\n* 12.Pregnant or lactating women.\n* 13\\. Accepting other investigational drugs.\n* 14.According to the researchers' assessment, the patient may have complications that could lead to other dangers.","55 Years",{"count":441,"type":20},59,[168],"This study is a prospective, phase II clinical trial with the primary objective of assessing the effectiveness of demethylating agents combined with venetoclax in the prevention of recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT) of high risk T-lymphoblastic lymphoma\u002Fleukemia (T-LBL\u002FALL) patients.",[445,446,27],"T-cell Acute Lymphoblastic Leukemia","ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION",[448,257,449],"T-cell lymphoblastic lymphoma\u002Fleukemia","allogeneic hematopoietic stem cell transplantation","2025-05-04",{"date":452,"type":37},"2025-05-07",{"date":454,"type":37},"2024-10-30",{"date":456,"type":20},"2028-10-30",{"name":458,"class":44},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":390,"enrollmentInfo":467,"targetDuration":4,"studyType":21,"phases":469,"briefSummary":470,"conditions":471,"keywords":477,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":495},"100524217","neurobehavioral-profiles-of-adaptive-stress-responses-in-individuals-with-alcohol-use-disorder-100524217","NCT06105853","Neurobehavioral Profiles of Adaptive Stress Responses in Individuals With Alcohol Use Disorder","Towards Neurobehavioral Profiles and Models of Adaptive Stress Responses and Resilience in Individuals With Alcohol Use Disorder","A03","Inclusion criteria are:\n\n* age between 16 and 65 years\n* meeting at least 2 criteria of an alcohol use disorder according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5), yet without the need for a therapeutic intervention\n* fluency in German\n* able to understand the study procedures and give informed consent\n* willingness to use a study smartphone\n\nExclusion criteria are:\n\n* current use of drugs or medications that interact with the central nervous system or the glucocorticoid system\n* contraindications for magnetic resonance imaging\n* medical history of bipolar disorder, psychotic disorder, schizophrenia or schizophrenic spectrum disorder, or substance use disorder other than alcohol, nicotine, or cannabis\n* medical history of severe head injury or other severe central nervous system disorders or other severe somatic disorders (e.g. liver cirrhosis)\n* pregnancy",{"count":468,"type":20},100,[69],"The goal of this observational study is to investigate longitudinal stress response profiles and adaptive versus non-adaptive stress responses in alcohol use disorder. The main questions the projects aims to answer are:\n\nWhat are the neurobehavioral underpinnings of adaptive stress responses and resilience to repeated stress exposure with regards to:\n\n* alcohol craving?\n* alcohol use?\n* their modulation by prior stress exposure, social interactions, coping strategies and individual health behavior?\n\nParticipants will:\n\n* be exposed to an established experimental stress-induction protocol, the Trier Social Stress Test\n* be exposed to their favorite drink in a bar lab environment\n* be assessed using fMRI to determine their neural alcohol cue reactivity, response inhibition, and emotion processing\n* conduct an ambulatory phase to assess stressors, alcohol craving, substance use and details on social interactions, health behavior and coping strategies using ecological momentary assessment tools.",[72,472,473,474,27,475,476],"Stress Reaction","Social Stress","Craving","Addiction, Alcohol","Risk Behavior",[478,479,480,481,482,483,484,485],"stress","resilience","craving","sensitization","habituation","cortisol","ecological momentary assessment","alcohol use disorder","2025-04-28",{"date":488,"type":37},"2025-04-29",{"date":490,"type":37},"2023-12-01",{"date":492,"type":20},"2027-06-30",{"name":494,"class":44},"Central Institute of Mental Health, Mannheim",2,{"id":497,"slug":498,"hasResults":11,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":21,"phases":505,"briefSummary":506,"conditions":507,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":515,"locationsCount":45},"100572765","phase-1-chiglitazar-sodium-combined-with-venetoclax-and-azacitidine-cva-for-the-treatment-of-rr-aml-100572765","NCT06737523","Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of R\u002FR AML","A Multicenter, Prospective, Single-arm Clinical Study of Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of Refractory\u002FRelapsed Acute Myeloid Leukemia (R\u002FR AML)","Inclusion Criteria:\n\n1. Acute myeloid leukemia (AML) confirmed by histology. Relapsed or refractory AML, including: a) Refractory disease is defined as no remission after at least one prior treatment. b) Disease relapse is defined as 5% or more blasts in the bone marrow after remission. c) Patients with AML arising from myelodysplastic syndromes (including CMML) or myeloproliferative neoplasms (secondary AML, t-AML) are also eligible;\n2. Age ≥18 years, male or female, with an expected survival of more than 3 months;\n3. Estimated creatinine clearance ≥ 50 mL\u002Fmin;\n4. AST and ALT ≤ 3.0 x ULN (unless considered due to leukemia organ involvement), bilirubin ≤ 3.0 x ULN (unless considered due to leukemia organ involvement);\n5. ECOG ≤ 2;\n6. Subjects are non-pregnant or using contraceptive measures during treatment;\n7. Capable of understanding and voluntarily providing informed consent.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia (APL);\n2. Active central nervous system leukemia;\n3. Patients with clinically significant QTc interval prolongation (males \\> 450 ms; females \\> 470 ms), ventricular tachycardia and atrial fibrillation, second-degree heart block, history of myocardial infarction and congestive heart failure within the year prior to enrollment, and patients with clinically symptomatic coronary heart disease requiring medication;\n4. Active, uncontrolled severe infection;\n5. Other non-myeloid malignancies within the past 2 years;\n6. Mental disorders that would impede study participation;\n7. Previous solid organ transplantation (pre-treatment with SCT is allowed, but not allowed if the patient has GVHD or is still receiving immunosuppressive\u002FGVHD treatment);\n8. Any other conditions that, in the opinion of the investigator, make the patient unsuitable to participate in this trial.",{"count":504,"type":20},30,[23],"To investigate the safety and efficacy of the CVA regimen, composed of Chiglitazar Sodium in combination with Venetoclax and Azacitidine, in the treatment of patients with refractory\u002Frelapsed acute myeloid leukemia (R\u002FR AML).",[197,27,508],"Refractory AML","2025-02-21",{"date":511,"type":37},"2025-02-24",{"date":513,"type":20},"2025-03-15",{"date":430,"type":20},{"name":516,"class":44},"The First Affiliated Hospital of Xiamen University",{"id":518,"slug":519,"hasResults":11,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":189,"enrollmentInfo":524,"targetDuration":4,"studyType":21,"phases":526,"briefSummary":527,"conditions":528,"keywords":530,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":4},"100574073","phase-2-azacitidine-combined-with-donor-lymphocyte-infusion-for-acute-myeloid-leukemia-post-transplant-relapse-prevention-100574073","NCT06754540","Azacitidine Combined with Donor Lymphocyte Infusion for Acute Myeloid Leukemia Post-transplant Relapse Prevention.","Efficacy and Safety of Azacitidine Combined with Donor Lymphocyte Infusion for Prevention of Recurrence After Haploid Hematopoietic Stem Cell Transplantation in High-risk Acute Myeloid Leukemia","Inclusion Criteria:\n\n\\-\n\nPatients enrolled must meet the following criteria:\n\n1. ≥18 years old and ≤70 years old, male or female;\n2. Patients with haploid peripheral blood stem cell transplantation of AML;\n3. All patients received BU based myeloablative conditionings;\n4. A diagnosis of high-risk AML is one of the following:\n\n   ① Patients without morphologic CR before transplantation, including patients with initial refractory disease and recurrence.\n\n   ② AML with poor prognosis (Standardized diagnosis and prognostic stratification of acute myeloid leukemia based on ELN edition which was 2022 Year) .\n5. Blood routine: neutrophils ≥1×10\\^9\u002FL, platelet ≥50.0×10\\^9\u002FL;\n6. There is no active grade II or higher acute GVHD or moderate or severe chronic GVHD;\n7. The ECOG score is 0 to 2;\n8. Donor lymphocytes are available;\n9. The patient must be able to understand and be willing to participate in the study and sign an informed consent form.\n\nExclusion Criteria:\n\n* Possible subjects who meet any of the following criteria will be excluded from the trial:\n\n  1. Those who are allergic to known azacitidine or interferon\n  2. Patients with active acute GVHD;\n  3. Patients with moderate or more chronic GVHD;\n  4. Non-haploid donor transplants;\n  5. Patients who have not achieved complete remission after transplantation;\n  6. AML recurrence after transplantation (bone marrow, peripheral blood primitive cells ≥5% or extramedullary recurrence), or graft rejection, bone marrow donor cell chimeric rate (STR) \\\u003C90%;\n  7. Patient blood routine: ANC\\\u003C1.0×10\\^9\u002FL or PLT\\\u003C50×10\\^9\u002FL;\n  8. Combined with severe organ dysfunction:liver function (AST\u002FALT) \\>3 times normal upper limit; the direct bilirubin \\> 3 times normal upper limit; renal function (Cr) \\\u003C 50mL\u002Fmin or \\>1.5 times normal upper limit, regardless of hemodialysis treatment;\n  9. Patient with severe active infection;\n  10. Pregnant or lactating women;\n  11. Have received other interventions or are receiving other research drugs before the study begins;\n  12. At the discretion of the investigator, other dangerous complications may result.",{"count":525,"type":20},51,[168],"This study is single-center, single-arm, prospective, Phase II clinical trial with the primary objective of assessing the effectiveness of azacitidine combined with donor lymphocyte infusion (DLI) in the prevention of recurrence after high-risk haploid hematopoietic stem cells of AML.\n\nAt the screening\u002Fbaseline period, informed consent is obtained and the inclusion\u002Fexclusion criteria are checked. Plan to enroll 51 patients, and collect demographic data, medical history data, vital signs, physical examination and laboratory tests (blood routine; urine routine; liver and kidney function;Immune indicators: T cell subsets, Treg, etc.), pregnancy tests for female patients and other necessary auxiliary inspections.The time to start treatment is from the +90 to +180 days after high-risk AML haploid hematopoietic stem cell transplantation.",[529,27],"Acute Myeloid Leukemia (AML)",[531,532,200,533,534,535],"azacitidine","donor lymphocyte infusion","haploid","high-risk","AML","2025-01-14",{"date":538,"type":37},"2025-01-17",{"date":540,"type":20},"2025-01-16",{"date":542,"type":20},"2027-01-01",{"name":458,"class":44},{"id":545,"slug":546,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":113,"sex":16,"minAge":17,"maxAge":114,"enrollmentInfo":550,"targetDuration":4,"studyType":21,"phases":551,"briefSummary":552,"conditions":553,"keywords":556,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":45},"100551187","comparative-evaluation-of-change-in-bite-force-and-levels-of-bone-turnover-markers-ctx-and-balp-in-hyperdivergent-and-hypodivergent-cases-during-retention-phases-a-prospective-clinical-trial--100551187","NCT06456827","''Comparative Evaluation of Change in Bite Force and Levels of Bone Turnover Markers CTX and BALP in Hyperdivergent and Hypodivergent Cases During Retention Phases-A Prospective Clinical Trial ''","Inclusion Criteria:\n\n* Non - growing (18-25) patients who had finished Fixed orthodontic cases ( ready for debonding )with FMA of 26 or more for hyperdivergent cases and FMA of 24 or less for hypodivergent cases\n* Optimal functional occlusion at end of treatment (PAR score \\>70%).\n* Littles irregularity index (Pre-treatment \\\u003C6mm in both upper and lower arch).\n* Nonsurgical and non-orthopedic patients and non syndromic patients.\n* Optimal periodontal condition and Good oral hygiene (probing depth \\\u003C3mm, gingival index score \\\u003C1\n* Good compliance regarding retainer wear\n\nExclusion Criteria:\n\n* Subjects with incomplete orthodontic treatment.\n* TMJ disorder patients.\n* Any systemic disease affecting bone and general growth.\n* Patients with incomplete records.\n* Patient who fail to follow up or undergo complete treatment.\n* Patient with learning difficulties\n* Patients having antibiotic therapy within previous 3 months and used anti -inflammatory drugs in the month before the study",{"count":166,"type":20},[69],"Long-term studies have shown that various occlusal changes occur after the active phase of orthodontic treatment. some of these changes are unwanted changes and are considered as relapse The retention appliances are used to maintain the arch dimensions and alignment of the teeth after completion of the orthodontic treatment. One indicator of the functional state and health of the masticatory system is maximum voluntary bite force (MVBF). Its values vary in accordance to the location of measurement (highest at the first molar, lower at the incisors). People with pronounced horizontal craniofacial growth have somewhat higher values of MVBF, and those with vertical growth have lower values than do those with an average growth pattern. Clinical case reports and descriptive histologic data exist suggesting that bone and tooth remodeling persist for extended periods after removal of appliance or deactivation. A reflection of bone remodelling can be found in the gingival crevicular fluid (GCF) of moving teeth, with decrease or increase in the concentration of biomarker. This prompted us to evaluate the expression of variation in bone turnover marker levels (CTX-Bone resorption marker and BALP -Bone formation marker ) during the retention period. The International Osteoporosis Foundation (IOF) and International Federation of Clinical Chemistry (IFCC) have recommended C-terminal telopeptide of type I collagen (CTX) as one of the reference for BTMs. Hence, The present trial will be undertaken to assess the changes and compare if there is any difference in bite force and change in level of bone biomarker biomarker CTX type 1 collagen(C-terminal telopeptide of type I collagen and bone specific alkaline phosphatase(BALP) in post orthodontic treatment hypodivergent and hyperdivergent cases using beggs retainer over 12 months of period of retention.",[27,554,555],"Bite Force","Biomarker",[557],"CTX and BALP biomarker , Bite force","2024-12-05",{"date":560,"type":37},"2024-12-10",{"date":562,"type":20},"2024-12-25",{"date":564,"type":20},"2026-08",{"name":129,"class":44},{"id":567,"slug":568,"hasResults":11,"nctId":569,"briefTitle":570,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":21,"phases":574,"briefSummary":575,"conditions":576,"keywords":579,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":4},"100529955","phase-1-allogeneic-immunotherapy-of-hematological-malignancies-using-regulatory-t-cell-selective-depletion-100529955","NCT06180499","Allogeneic Immunotherapy of Hematological Malignancies Using Regulatory T-cell Selective Depletion","ILDTreg2","Inclusion Criteria:\n\n* Adult patient (older than 18 years old without upper limit of age) diagnosed with leukemia, myelodysplasia, myeloproliferative disorder or lymphoproliferative disorder (CLL, myeloma, lymphoma)\n* Previous allogeneic HSCT from a matched sibling, haplo-identical or unrelated donor (any type of conditioning regimen)\n* Haematological relapse (molecular, cytogenetic or cytological) after HSCT\n* Patient refractory (no or partial response) to one or several previous standard unmanipulated DLI\n* Availability of cryopreserved lymphapheresis\n* No loss of chance by using of DLI rather than more incisive anti-tumor agents according to investigator appreciation\n* Written informed consent before any intervention necessary for the trial\n* Affiliation to a social security regime\n* Negative pregnancy test for women of childbearing age participating in the study\n* Effective contraceptive methods for men \u002F women in line with the current CTFG recommendations version 1.1\n\nExclusion Criteria:\n\n* Acute grade ≥ II or moderate\u002Fsevere chronic GVHD at the time of inclusion\n* Patient receiving immunosuppressive treatment for GVHD or any other reason\n* Creatinine clearance\\\u003C 50 ml\u002Fmin\n* Serum aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)\u002Fserum glutamate pyruvate transaminase (SGPT) \\> 5.0 x upper limit of normal (ULN)\n* Serum total bilirubin \\> 50µM (expect for unconjugated hyperbilirubinemia due to Gilbert's disease)\n* Performance status ECOG\\>1\n* Severe infection according to CTCAE grading (grade\\>2)\n* Pregnant or lactating women\n* Patient under tutorship, curatorship or legal protection\n* Ongoing participation in another interventional research protocol within the same field of immune modulation (through cell therapy or not)\n* State medical aid",{"count":93,"type":20},[23,168],"Since the discovery that Treg suppress anti-tumor immune responses, inhibiting their function has become a major challenge for the development of efficient immunotherapy for cancer. In humans, we previously reported the positive results of a first clinical trial using Treg depletion for anti-tumor response amplification in the field of allogeneic hematopoietic stem cell transplantation (HSCT). The present project aims at developing this anti-tumor immunotherapeutic strategy in the same setting, i.e. donor lymphocyte infusion (DLI) for relapsing hematological malignancies after HSCT, using a new selection marker: CD127. The choice of this new strategy is supported by our results of a retrospective clinical study and pre-clinical data. Using human cells, this studies demonstrated, in vitro and in vivo in animal murine models, that Treg depletion through CD127 positive selection is much more efficient to improve allogeneic immune responses of donor T-cells as compared to the previous strategy using the CD25 marker.",[577,578,27],"Hematological Malignancies","Regulatory T Cell Depletion",[580,581,582,27],"DLI","Regulatory T cells depletion","Hematological malignancies","2024-02-12",{"date":585,"type":37},"2024-02-14",{"date":587,"type":20},"2024-03",{"date":589,"type":20},"2029-09",{"name":591,"class":44},"Assistance Publique - Hôpitaux de Paris",{"id":593,"slug":594,"hasResults":11,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":390,"enrollmentInfo":599,"targetDuration":4,"studyType":21,"phases":601,"briefSummary":603,"conditions":604,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":45},"100474739","phase-4-effects-of-different-treatment-schemes-on-the-regulation-and-recurrence-of-graves-disease-100474739","NCT05461820","Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease","Clinical Study on the Effect of Routine Treatment and Intensive Treatment on the Regulation of Graves' Disease and the Cumulative Recurrence Two Years After Drug Withdrawal","Inclusion Criteria:\n\n* Graves hyperthyroidism (responsible for doctors' clinical diagnosis)\n* Age 18-65, for both men and women\n* Thyroid receptor antibody (TRAb) was positive\n* Take part in this research voluntarily and sign the informed consent form\n\nExclusion Criteria:\n\n* Those who have used glucocorticoid or other immunosuppressants for a long time within 3 months before being selected\n* Those who have participated in any other drug trials within 3 months before being selected\n* Subjects who are participating in clinical research of other drugs\n* Patients with a history of malignant tumors\n* Ill-controlled hypertension: diastolic blood pressure≥100mmHg, systolic blood pressure ≥160 mmHg\n* Blood routine: the total number of white blood cells \\\u003C 3.0×109 or neutrophils \\\u003C 1.5× 109\n* Other thyroid diseases: such as subacute thyroiditis, thyroid nodules, high-function adenoma\n* Alanine aminotransferase(ALT) or aspartate amino transferase(AST) is greater than 2 times of the normal upper limit; When ALT or AST is less than 2 times of the normal upper limit, and the test of hepatitis B two half-and-half positive\n* Renal insufficiency: serum creatinine is higher than the upper limit of normal value\n* Patients with heart failure\n* Patients with coronary heart disease\n* Patients with other autoimmune diseases\n* Patients who are known to be allergic to any component of this medicine are allergic to the active ingredients or any auxiliary materials in the prescription\n* Patients with multiple drug allergies, allergic diseases, people with high sensitivity and drug addicts\n* Alcoholism, mental disorder or other observers who are not suitable for drug testing\n* Pregnant and lactating women cannot rule out the possibility of pregnancy\n* Taking any medicine with unknown ingredients or using traditional Chinese medicine, the researcher judges the medicine that may affect the curative effect of hyperthyroidism\n* According to the researcher's judgment, other medical history that reduces the possibility of joining the group or complicates the joining of the group, such as frequent changes in the working environment, may easily lead to lost follow-up.\n\nRejection Criteria:\n\n* The compliance of this clinical trial protocol is \\\u003C 80% or \\> 120%;\n* Those who did not meet the inclusion criteria or the exclusion criteria were found during the experiment;\n* Those who can't cooperate, including those who can't complete the whole course of treatment, don't complete the follow-up as planned, and increase or decrease adjuvant drugs at will;\n* During the trial, use other drugs that may affect the curative effect of this trial.\n\nTermination of Research Criteria:\n\n* Those who are allergic or intolerant to this drug;\n* Adverse reactions or serious adverse events that patients can't tolerate occur;\n* Pregnant women of childbearing age in the experiment;\n* Other diseases appear during the treatment, and the treatment of accompanying diseases will interfere with the clinical observers of this medicine;\n* The researcher thinks it is inappropriate to continue the experiment.",{"count":600,"type":20},240,[602],"PHASE4","In this study, the dose of methimazole was adjusted according to the different states of thyroid function, and the effects of conventional therapy and intensive therapy on the cumulative recurrence of Graves' hyperthyroidism after two years of drug withdrawal were evaluated. At the same time, the changes of immune indexes and inflammatory factors in the regulation process were evaluated. This study is a phase IV clinical study designed and carried out by the First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), which is a randomized, open and routine treatment group with parallel control.",[605,27,606,607],"Graves Disease","Treatment","Drug Withdrawal","2023-12-08",{"date":610,"type":37},"2023-12-11",{"date":612,"type":37},"2018-05-01",{"date":614,"type":20},"2030-07-31",{"name":616,"class":44},"The First Affiliated Hospital with Nanjing Medical University"]