[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468815":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":276,"collaborators":279,"id":283,"slug":284,"hasResults":285,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":285,"sex":291,"minAge":292,"maxAge":30,"enrollmentInfo":293,"targetDuration":30,"studyType":296,"phases":297,"briefSummary":299,"conditions":300,"keywords":303,"overallStatus":54,"whyStopped":30,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":317},{"fullName":5,"class":6},"University of Leipzig","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Luspatercept","Single-arm design: All patients are treated with 1.75 mg Luspatercept per kg body weight subcutaneously on day 1 of each 21 day cycle for up to 24 weeks and in case of response for up to 1.5 years.",[12],"Drug: Luspatercept Injection",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Luspatercept Injection","All formally included patients will receive 1.75 mg\u002Fkg luspatercept administered subcutaneously every three weeks (on day 1 of each 21-day cycle) for a duration of 24 weeks.\n\nResponders at the response assessment (according to HI-E) in week 25 will be further treated with 1.75 mg\u002Fkg luspatercept until loss of response for an expected maximum of 18 months.",[9],[20],"LUS",[22],{"name":23,"affiliation":24,"role":25},"Anne Sophie Kubasch, Dr.","University Leipzig","PRINCIPAL_INVESTIGATOR",[27,32],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","+49 341 97-13050",null,"annesophie.kubasch@medizin.uni-leipzig.de",{"name":33,"role":28,"phone":30,"phoneExt":30,"email":34},"Uwe Platzbecker, Prof. Dr.","uwe.platzbecker@medizin.uni-leipzig.de",[36,52,65,77,89,101,113,123,135,147,158,167,175,184,193,205,214,225,234,246,255,264],{"facility":37,"status":38,"city":39,"state":30,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Praxis für Hämatologie und Onkologie Berlin-Mitte","NOT_YET_RECRUITING","Berlin","10117","Germany","DE",{"type":44,"coordinates":45},"Point",[46,47],13.41053,52.52437,{"lat":47,"lon":46},[50],{"name":51,"role":28,"phone":30,"phoneExt":30,"email":30},"Stephan Fuhrmann, Dr.",{"facility":53,"status":54,"city":55,"state":30,"zip":56,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Universitätsklinikum Bonn","RECRUITING","Bonn","53127",{"type":44,"coordinates":58},[59,60],7.09549,50.73438,{"lat":60,"lon":59},[63],{"name":64,"role":28,"phone":30,"phoneExt":30,"email":30},"Karin Mayer, Dr.",{"facility":66,"status":54,"city":67,"state":30,"zip":68,"country":41,"countryCode":42,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Carl-Thiem-Klinikum Cottbus gGmbH","Cottbus","03048",{"type":44,"coordinates":70},[71,72],14.32888,51.75769,{"lat":72,"lon":71},[75],{"name":76,"role":28,"phone":30,"phoneExt":30,"email":30},"Maximilian Desole, Dr.",{"facility":78,"status":38,"city":79,"state":30,"zip":80,"country":41,"countryCode":42,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"OncoSearch Institut für klinische Studien GbR","Erlangen","91052",{"type":44,"coordinates":82},[83,84],11.00783,49.59099,{"lat":84,"lon":83},[87],{"name":88,"role":28,"phone":30,"phoneExt":30,"email":30},"Babette Häcker, Dr.",{"facility":90,"status":38,"city":91,"state":30,"zip":92,"country":41,"countryCode":42,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Universitätsmedizin Greifswald Klinik Innere Medizin C \u002F Hämatologie und Onkologie","Greifswald","17475",{"type":44,"coordinates":94},[95,96],13.40244,54.08905,{"lat":96,"lon":95},[99],{"name":100,"role":28,"phone":30,"phoneExt":30,"email":30},"Florian Heidel, Prof. Dr.",{"facility":102,"status":38,"city":103,"state":30,"zip":104,"country":41,"countryCode":42,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"OncoResearch Lerchenfeld GmbH","Hamburg","22081",{"type":44,"coordinates":106},[107,108],9.99302,53.55073,{"lat":108,"lon":107},[111],{"name":112,"role":28,"phone":30,"phoneExt":30,"email":30},"Thomas Wolff, Dr.",{"facility":114,"status":115,"city":116,"state":30,"zip":117,"country":41,"countryCode":42,"cosmosGeoPoint":118,"geoPoint":122,"contacts":30},"Klinikum Kassel GmbH Klinik für Hämatologie, Onkologie und Immunologie","ACTIVE_NOT_RECRUITING","Kassel","34125",{"type":44,"coordinates":119},[120,121],9.5,51.31667,{"lat":121,"lon":120},{"facility":124,"status":38,"city":125,"state":30,"zip":126,"country":41,"countryCode":42,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"InVO Institut für Versorgungsforschung in der Onkologie GbR","Koblenz","56068",{"type":44,"coordinates":128},[129,130],7.57883,50.35357,{"lat":130,"lon":129},[133],{"name":134,"role":28,"phone":30,"phoneExt":30,"email":30},"Christoph Lutz, PD Dr.",{"facility":136,"status":54,"city":137,"state":30,"zip":138,"country":41,"countryCode":42,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"VK&K Studien GbR","Landshut","84036",{"type":44,"coordinates":140},[141,142],12.16179,48.52961,{"lat":142,"lon":141},[145],{"name":146,"role":28,"phone":30,"phoneExt":30,"email":30},"Florian Kaiser, PD Dr.",{"facility":148,"status":54,"city":149,"state":30,"zip":150,"country":41,"countryCode":42,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Universität Leipzig - Medizinische Fakultät Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie","Leipzig","04103",{"type":44,"coordinates":152},[153,154],12.37129,51.33962,{"lat":154,"lon":153},[157],{"name":23,"role":28,"phone":30,"phoneExt":30,"email":30},{"facility":159,"status":115,"city":160,"state":30,"zip":161,"country":41,"countryCode":42,"cosmosGeoPoint":162,"geoPoint":166,"contacts":30},"Mannheimer Onkologie Praxis","Mannheim","68161",{"type":44,"coordinates":163},[164,165],8.46694,49.4891,{"lat":165,"lon":164},{"facility":168,"status":38,"city":160,"state":30,"zip":30,"country":41,"countryCode":42,"cosmosGeoPoint":169,"geoPoint":171,"contacts":172},"Universitätsklinikum Mannheim, III Medizinische Klinik - Hämatologie und Internistische Onkologie",{"type":44,"coordinates":170},[164,165],{"lat":165,"lon":164},[173],{"name":174,"role":28,"phone":30,"phoneExt":30,"email":30},"Daniel Nowak, Prof.",{"facility":176,"status":115,"city":177,"state":30,"zip":178,"country":41,"countryCode":42,"cosmosGeoPoint":179,"geoPoint":183,"contacts":30},"Klinikum Hochsauerland GmbH","Meschede","59870",{"type":44,"coordinates":180},[181,182],8.28332,51.3502,{"lat":182,"lon":181},{"facility":185,"status":115,"city":186,"state":30,"zip":187,"country":41,"countryCode":42,"cosmosGeoPoint":188,"geoPoint":192,"contacts":30},"Kliniken Maria Hilf GmbH Klinik für Hämatologie, Onkologie und Gastroenterologie","Mönchengladbach","41063",{"type":44,"coordinates":189},[190,191],6.44172,51.18539,{"lat":191,"lon":190},{"facility":194,"status":54,"city":195,"state":30,"zip":196,"country":41,"countryCode":42,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Gemeinschaftspraxis Häamto-Onkologie","München","81241",{"type":44,"coordinates":198},[199,200],13.31243,51.60698,{"lat":200,"lon":199},[203],{"name":204,"role":28,"phone":30,"phoneExt":30,"email":30},"Matthias Zingerle, Dr.",{"facility":206,"status":54,"city":195,"state":30,"zip":207,"country":41,"countryCode":42,"cosmosGeoPoint":208,"geoPoint":210,"contacts":211},"Klinikum rechts der Isar der TU München III. Medizinische Klinik - Hämatologie und Onkologie","81675",{"type":44,"coordinates":209},[199,200],{"lat":200,"lon":199},[212],{"name":213,"role":28,"phone":30,"phoneExt":30,"email":30},"Katharina Götze, Prof. Dr.",{"facility":215,"status":38,"city":216,"state":30,"zip":30,"country":41,"countryCode":42,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Universitätsklinikum Münster, Medizinische Klinik A","Münster",{"type":44,"coordinates":218},[219,220],7.62571,51.96236,{"lat":220,"lon":219},[223],{"name":224,"role":28,"phone":30,"phoneExt":30,"email":30},"Jan-Henrik Mikesch, PD Dr.",{"facility":226,"status":115,"city":227,"state":30,"zip":228,"country":41,"countryCode":42,"cosmosGeoPoint":229,"geoPoint":233,"contacts":30},"Studiengesellschaft Onkologie Rhein\u002FRuhrPraxis für Hämatologie und Onkologie Oberhausen und Düsseldorf","Oberhausen","46145",{"type":44,"coordinates":230},[231,232],6.8625,51.47805,{"lat":232,"lon":231},{"facility":235,"status":38,"city":236,"state":30,"zip":237,"country":41,"countryCode":42,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"Universitätsmedizin Rostock Klinik III (Hämatologie, Onkologie, Palliativmedizin) Zentrum für Innere Medizin","Rostock","18057",{"type":44,"coordinates":239},[240,241],12.14049,54.0887,{"lat":241,"lon":240},[244],{"name":245,"role":28,"phone":30,"phoneExt":30,"email":30},"Christoph Wittke, Dr.",{"facility":247,"status":115,"city":248,"state":30,"zip":249,"country":41,"countryCode":42,"cosmosGeoPoint":250,"geoPoint":254,"contacts":30},"Praxis ONKOSAAR Praxis für Hämatologie und Onkologie","Saarbrücken","66113",{"type":44,"coordinates":251},[252,253],7.00982,49.23262,{"lat":253,"lon":252},{"facility":256,"status":115,"city":257,"state":30,"zip":258,"country":41,"countryCode":42,"cosmosGeoPoint":259,"geoPoint":263,"contacts":30},"Klinikum Mutterhaus","Trier","54290",{"type":44,"coordinates":260},[261,262],6.63935,49.75565,{"lat":262,"lon":261},{"facility":265,"status":54,"city":266,"state":30,"zip":267,"country":41,"countryCode":42,"cosmosGeoPoint":268,"geoPoint":272,"contacts":273},"Universitätsklinikum Tübingen Medizinische Klinik II, AML\u002FALL\u002FMDS","Tübingen","72076",{"type":44,"coordinates":269},[270,271],9.05222,48.52266,{"lat":271,"lon":270},[274],{"name":275,"role":28,"phone":30,"phoneExt":30,"email":30},"Maximilian Christopeit, PD Dr.",{"type":25,"investigatorFullName":277,"investigatorTitle":278,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Anne Sophie Kubasch","Coordinating Investigator",[280],{"name":281,"class":282},"Celgene Corporation","INDUSTRY","100468815","phase-2-efficacy-of-luspatercept-in-esa-naive-lr-mds-patients-with-or-without-ring-sideroblasts-who-do-not-require-transfusions-100468815",false,"NCT05384691","Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions","A Phase II, Open-label, Single Arm Study to Evaluate the Efficacy of Luspatercept in Erythropoiesis-stimulating Agent Naive Lower-risk MDS Patients With or Without Ring Sideroblasts Who do Not Require RBC Transfusions","LENNON","Inclusion Criteria:\n\n* Diagnosis of myelodysplastic syndrome (MDS) according to WHO classification\n* Very low-, low-, or intermediate-risk disease MDS with up to 3.5 according to revised International Prognostic Scoring System (IPSS-R)\n* Less than 5% blasts in bone marrow\n* Peripheral blood white blood cell (WBC) count \\\u003C 13,000\u002FμL\n* sEPO levels ≤ 500 mU\u002FmL\n* Non-transfusion dependence (NTD) according to IWG 2018 criteria\n* Symptomatic anemia\n* Age \\> 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Patient does not accept bone marrow sampling during screening and during treatment\n* Patient does not accept regular peripheral blood sampling for screening and during treatment.\n* Patient does not accept subcutaneous application of LUS every three weeks\n* Prior treatment for anemia associated with MDS (i.e. ESA, luspatercept), except previously treated with G-CSF\u002Fgranulocyte-macrophage colony-stimulating factor (GM-CSF), both agents must be discontinued at least 4 weeks before registration\n* Secondary MDS, i.e. MDS arising as the result of chemical injury or treatment with chemotherapy and\u002For radiation for other diseases\n* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding.\n* Prior allogeneic or autologous stem cell transplant\n* Prior history of AML\n* Prior history of malignancies, other than MDS, unless the subject is free of the disease (including completion of any active or adjuvant treatment for prior malignancy) for ≥ 5 years.\n* Major surgery within 8 weeks prior to registration.\n* Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure ≥160 mmHg or of diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment\n* Platelet count \\\u003C 30,000\u002FμL (30 × 10\\^9\u002FL)\n* Estimated glomerular filtration rate or creatinine clearance \\\u003C 40 mL\u002Fmin\n* Aspartate aminotransferase (AST)\u002Fserum glutamic oxaloacetic transaminase (SGOT) ≥ 3.0 × upper limit of normal (ULN)\n* Alanine aminotransferase (ALT)\u002Fserum glutamic pyruvic transaminase (SGPT) ≥ 3.0 × ULN\n* Total bilirubin ≥ 2.0 × ULN\n* Eastern Cooperative Oncology Group (ECOG) performance status \\> 2\n* Stroke, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to registration\n* Myocardial infarction, uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia within 6 months prior to registration.\n* Subjects with a known ejection fraction of ˂ 35%, confirmed by a local echocardiography or multigated acquisition scan (MUGA) performed within 6 months prior to registration, are excluded\n* Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment), known human immunodeficiency virus (HIV), known evidence of active infectious hepatitis B, and\u002For known evidence of active hepatitis C.\n* History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the IMP\n* Subject has any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (e.g., imprisoned or institutionalized) that would prevent the subject from participating in the study.\n* Subject has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe participates in the study\n* Subject has any condition or concomitant medication that confounds the ability to interpret data from the study.\n* Use of any of the following within five weeks prior to registration are prohibited: Anticancer cytotoxic chemotherapeutic agent or treatment, Corticosteroid, except for subjects on a stable or decreasing dose for ≥ 1 week prior to inclusion for medical conditions other than MDS, Iron chelation therapy, except for subjects on a stable or decreasing dose for at least 8 weeks prior to registration, Other RBC hematopoietic growth factors (e.g. interleukin \\[IL\\]-3)\n* Pregnant or breastfeeding females\n* Positive pregnancy test in women of childbearing potential.\n* Female subjects of childbearing potential unwilling to use a highly effective method of contraception for the course of the study through 90 days after the last dose of study medication.\n* Male subjects with procreative capacity not willing to use a highly effective method of contraception, starting with the first dose of study therapy through 90 days after the last dose of study therapy.\n* Participation in other interventional trials.\n* Patients under legal supervision or guardianship.","ALL","18 Years",{"count":294,"type":295},213,"ESTIMATED","INTERVENTIONAL",[298],"PHASE2","Anemia in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS), that are non-transfusion dependent",[301,302],"Myelodysplastic Syndromes","Anemia",[304,302,305,306,307],"MDS","Ring sideroblast","Low risk","non-transfusion dependence (NTD)","2024-01-30",{"date":310,"type":311},"2024-01-31","ACTUAL",{"date":313,"type":311},"2022-09-27",{"date":315,"type":295},"2027-07-31",{"name":5,"class":6},22]