[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475950":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":41,"locations":51,"responsibleParty":363,"collaborators":45,"id":365,"slug":366,"hasResults":367,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":367,"sex":373,"minAge":45,"maxAge":374,"enrollmentInfo":375,"targetDuration":45,"studyType":378,"phases":379,"briefSummary":381,"conditions":382,"keywords":385,"overallStatus":143,"whyStopped":45,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":400},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BuCyMel","ACTIVE_COMPARATOR","a combination of busulfan, cyclophosphamide and melphalan, conditioning regimen",[13],"Drug: busulfan, cyclophosphamide and melphalan, BuCyMel",{"label":15,"type":16,"description":17,"interventionNames":18},"CloFluBu","EXPERIMENTAL","a combination of clofarabine, fludarabine and busulfan conditioning regimen",[19],"Drug: clofarabine, fludarabine and busulfan, CloFluBu",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","busulfan, cyclophosphamide and melphalan, BuCyMel","a three alkylator combination of busulfan, cyclophosphamide and melphalan (BuCyMel, standard arm)",[9],[9],{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"clofarabine, fludarabine and busulfan, CloFluBu","combination of clofarabine, fludarabine and busulfan in which two alkylators are replaced by antimetabolites (CloFluBu, experimental arm)",[15],[15],[33,37],{"name":34,"affiliation":35,"role":36},"Karin Mellgren, Prof. MD","Sahlgrenska University Hospital","STUDY_CHAIR",{"name":38,"affiliation":39,"role":40},"Birgitta Versluys, MD, Phd","Princess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands","PRINCIPAL_INVESTIGATOR",[42,47],{"name":34,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","+46 (0)31 3421000",null,"karin.mellgren@vgregion.se",{"name":48,"role":43,"phone":49,"phoneExt":45,"email":50},"Anna M Schröder Håkansson, RN","+46 (0) 761141327","anna.schroder_hakansson@vgregion.se",[52,75,85,104,123,141,163,183,197,215,236,253,270,291,310,330,348],{"facility":53,"status":54,"city":55,"state":45,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"L'Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)","NOT_YET_RECRUITING","Brussels","1020","Belgium","BE",{"type":60,"coordinates":61},"Point",[62,63],4.34878,50.85045,{"lat":63,"lon":62},[66,70,74],{"name":67,"role":43,"phone":68,"phoneExt":45,"email":69},"Pauline Mazilier, MD, PhD","0032 2 477 26 78","Pauline.mazilier@huderf.bf",{"name":71,"role":43,"phone":72,"phoneExt":45,"email":73},"Yousra Hadrani","0032 2 477 35 21","Yousra.Hadrani@huderf.be",{"name":67,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":76,"status":54,"city":55,"state":45,"zip":77,"country":57,"countryCode":58,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Cliniques Universitaires Saint-Luc (CUSL)","1200",{"type":60,"coordinates":79},[62,63],{"lat":63,"lon":62},[82,84],{"name":83,"role":43,"phone":45,"phoneExt":45,"email":45},"Cécile Boulanger, MD, PhD",{"name":83,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":86,"status":54,"city":87,"state":45,"zip":88,"country":57,"countryCode":58,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Department of Pediatric Hematology, Oncology and SCT, Ghent University Hospital","Ghent","9000",{"type":60,"coordinates":90},[91,92],3.71667,51.05,{"lat":92,"lon":91},[95,99,103],{"name":96,"role":43,"phone":97,"phoneExt":45,"email":98},"Victoria Bordon, MD, PhD","0032 9 332 58 60","Victoria.Bordon@uzgent.be",{"name":100,"role":43,"phone":101,"phoneExt":45,"email":102},"Marlies Bekaert","0032 9 332 05 15","Marlies.bekaert@uzgent.be",{"name":96,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":105,"status":54,"city":106,"state":45,"zip":107,"country":57,"countryCode":58,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"University Hospital Leuven","Leuven","3000",{"type":60,"coordinates":109},[110,111],4.70093,50.87959,{"lat":111,"lon":110},[114,118,122],{"name":115,"role":43,"phone":116,"phoneExt":45,"email":117},"Anne Uyttebroeck, MD, PhD","0032 16 34 39 72","Anne.uyttebroeck@uzleuven.be",{"name":119,"role":43,"phone":120,"phoneExt":45,"email":121},"An Michiels","0032 16 34 98 66","An.michiels@uzleuven.be",{"name":115,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":124,"status":54,"city":125,"state":45,"zip":126,"country":57,"countryCode":58,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Centre Hospitalier Régional de la Citadelle (CHR)\u002FCHU Liège","Liège","4000",{"type":60,"coordinates":128},[129,130],5.56749,50.63373,{"lat":130,"lon":129},[133,136,140],{"name":134,"role":43,"phone":45,"phoneExt":45,"email":135},"Evelyne Willems, MD, PhD","e.willems@chuliege.be",{"name":137,"role":43,"phone":138,"phoneExt":45,"email":139},"Catherine Sondag","0032 4 321 89 77","c.sondag@chuliege.be",{"name":134,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":142,"status":143,"city":144,"state":45,"zip":145,"country":146,"countryCode":147,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Paediatric Stem Cell Transplant and Immune Deficiency, Department of Pediatric and Adolescent Medicine, Section 4072, Rigshospitalet University Hospital of Copenhagen","RECRUITING","Copenhagen","DK-2100","Denmark","DK",{"type":60,"coordinates":149},[150,151],12.56553,55.67594,{"lat":151,"lon":150},[154,158,162],{"name":155,"role":43,"phone":156,"phoneExt":45,"email":157},"Marianne Ifversen, MD, PhD","+45 3545 0979","Marianne.Ifversen@regionh.dk",{"name":159,"role":43,"phone":160,"phoneExt":45,"email":161},"Luise Thellesen","+45 3545 3563","Luise.Thellesen@regionh.dk",{"name":155,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":164,"status":143,"city":165,"state":45,"zip":166,"country":167,"countryCode":168,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Division of Hematology, Oncology, and Stem Cell Transplantation, The New Children's Hospital, Helsinki University Hospital","Helsinki","FIN-00290","Finland","FI",{"type":60,"coordinates":170},[171,172],24.93545,60.16952,{"lat":172,"lon":171},[175,178,182],{"name":176,"role":43,"phone":45,"phoneExt":45,"email":177},"Samppa Ryhänen, MD, PhD","samppa.ryhanen@hus.fi",{"name":179,"role":43,"phone":180,"phoneExt":45,"email":181},"Anna Blubaum, RN","+358 40 483 8664","anna.blubaum@hus.fi",{"name":176,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":184,"status":54,"city":185,"state":45,"zip":45,"country":185,"countryCode":186,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Department of Pediatrics and Adolescent Medicine, Hong King Children's Hospital","Hong Kong","HK",{"type":60,"coordinates":188},[189,190],114.17469,22.27832,{"lat":190,"lon":189},[193,196],{"name":194,"role":43,"phone":45,"phoneExt":45,"email":195},"Daniel Cheuk, MD, PhD","cheukkld@hku.hk",{"name":194,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":198,"status":54,"city":199,"state":45,"zip":200,"country":201,"countryCode":202,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Schneider Children's Medical Center of Israel","Petah Tikva","4920235","Israel","IL",{"type":60,"coordinates":204},[205,206],34.88747,32.08707,{"lat":206,"lon":205},[209,213],{"name":210,"role":43,"phone":211,"phoneExt":45,"email":212},"Jerry Stein, MD,PhD","972-3-9253742","jstein@clalit.org.il",{"name":214,"role":40,"phone":45,"phoneExt":45,"email":45},"Jerry Stein, MD, PhD",{"facility":216,"status":54,"city":217,"state":45,"zip":218,"country":219,"countryCode":220,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Vilnius University Hospital Santaros Klinikos Center for Pediatric Oncology and Hematology","Vilnius","08661","Lithuania","LT",{"type":60,"coordinates":222},[223,224],25.2798,54.68916,{"lat":224,"lon":223},[227,231,235],{"name":228,"role":43,"phone":229,"phoneExt":45,"email":230},"Jelena Rascon, MD, PhD","+37069778361","jelena.rascon@gmail.com",{"name":232,"role":43,"phone":233,"phoneExt":45,"email":234},"Renata Blackute","+370 698 86225","renata.blackute@gmail.com",{"name":228,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":237,"status":143,"city":238,"state":45,"zip":239,"country":240,"countryCode":241,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"Princess Máxima Center for Pediatric Oncology","Utrecht","3584CS","Netherlands","NL",{"type":60,"coordinates":243},[244,245],5.12222,52.09083,{"lat":245,"lon":244},[248,252],{"name":249,"role":43,"phone":250,"phoneExt":45,"email":251},"Birgitta Versluys, MD, PhD","+31650006514","A.B.Versluijs@prinsesmaximacentrum.nl",{"name":249,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":254,"status":143,"city":255,"state":45,"zip":256,"country":257,"countryCode":258,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"Department of Pediatric Hematology and Oncology, Oslo University HospitalOslo University Hospital","Oslo","0424","Norway","NO",{"type":60,"coordinates":260},[261,262],10.74609,59.91273,{"lat":262,"lon":261},[265,269],{"name":266,"role":43,"phone":267,"phoneExt":45,"email":268},"Jochen Buechner, MD, PhD","+4747416023","jocbuc@ous-hf.no",{"name":266,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":271,"status":54,"city":272,"state":45,"zip":273,"country":274,"countryCode":275,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"Stemcelltransplant unit Hospital Niño Jesús","Madrid","28009","Spain","ES",{"type":60,"coordinates":277},[278,279],-3.70256,40.4165,{"lat":279,"lon":278},[282,286,289],{"name":283,"role":43,"phone":284,"phoneExt":45,"email":285},"Marta Gonzales Vicent Gonzales Vicent, MD, PhD","+34-915035938","martagonzalesvicent@gmail.com",{"name":287,"role":43,"phone":45,"phoneExt":45,"email":288},"José M Fernandez","chemafer@mac.com",{"name":290,"role":40,"phone":45,"phoneExt":45,"email":45},"José M Fernandez, MD, PhD",{"facility":292,"status":143,"city":293,"state":45,"zip":294,"country":295,"countryCode":296,"cosmosGeoPoint":297,"geoPoint":301,"contacts":302},"Queen Silvia Children's Hospital, Sahlgrenska University Hospital","Gothenburg","41685","Sweden","SE",{"type":60,"coordinates":298},[299,300],11.96679,57.70716,{"lat":300,"lon":299},[303,305,308],{"name":304,"role":43,"phone":44,"phoneExt":45,"email":46},"Karin Mellgren, Prof.MD",{"name":306,"role":43,"phone":44,"phoneExt":45,"email":307},"MD, PhD","cecilia.langenskiold@vgregion.se",{"name":309,"role":40,"phone":45,"phoneExt":45,"email":45},"Cecilia Langenskiöld, MD, PhD",{"facility":311,"status":143,"city":312,"state":45,"zip":313,"country":295,"countryCode":296,"cosmosGeoPoint":314,"geoPoint":318,"contacts":319},"Barncancercentrum, avdelning 64, Skane University Hospital","Lund","SE- 221 85",{"type":60,"coordinates":315},[316,317],13.19321,55.70584,{"lat":317,"lon":316},[320,323,326,327],{"name":321,"role":43,"phone":45,"phoneExt":45,"email":322},"Kees-Jan Pronk, MD, PhD","ornelis.pronk@skane.se",{"name":324,"role":43,"phone":45,"phoneExt":45,"email":325},"Yvonne Håkansson, RN","yvonne.hakansson@skane.se",{"name":321,"role":40,"phone":45,"phoneExt":45,"email":45},{"name":328,"role":329,"phone":45,"phoneExt":45,"email":45},"Dominik Turkiewicz, MD, PhD","SUB_INVESTIGATOR",{"facility":331,"status":54,"city":332,"state":45,"zip":333,"country":295,"countryCode":296,"cosmosGeoPoint":334,"geoPoint":338,"contacts":339},"Pediatric Hematology immunology and stem cell transplantation Astrid Lindgren children's Hospital Huddinge K86-88","Stockholm","141 86",{"type":60,"coordinates":335},[336,337],18.06871,59.32938,{"lat":337,"lon":336},[340,344,347],{"name":341,"role":43,"phone":342,"phoneExt":45,"email":343},"Mikael Sundin, MD, PhD","+46 8 585 848 43","mikael.sundin@ki.se",{"name":345,"role":43,"phone":45,"phoneExt":45,"email":346},"Gunilla Olofsson, RN","gunilla.h.olofsson@regionstockholm.se",{"name":341,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":349,"status":54,"city":350,"state":45,"zip":351,"country":295,"countryCode":296,"cosmosGeoPoint":352,"geoPoint":356,"contacts":357},"Childrens department for Blood and tumor diseases Uppsala University Hospital","Uppsala","SE-751 85",{"type":60,"coordinates":353},[354,355],17.63889,59.85882,{"lat":355,"lon":354},[358,362],{"name":359,"role":43,"phone":360,"phoneExt":45,"email":361},"Natalja Jackmann, MD, PhD","+46 186119639","natalja.jackmann@kbh.uu.se",{"name":359,"role":40,"phone":45,"phoneExt":45,"email":45},{"type":364,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100475950","phase-3-studying-conditioning-regimen-in-pediatric-transplantation---aml--script-aml-100475950",false,"NCT05477589","Studying Conditioning Regimen In Pediatric Transplantation - AML , SCRIPT-AML","A Randomized, Multi-Center Phase III Trial Comparing Two Conditioning Regimens (CloFluBu and BuCyMel) in Children With Acute Myeloid Leukemia Undergoing Allogeneic Stem Cell Transplantation.","SCRIPT-AML","Inclusion criteria for randomization part of the study:\n\n* Age ≤18 years at time of initial AML, age ≤ 21 years at transplantation.\n* HCT is performed in a study participating center\n* All women of childbearing potential who have to have a negative pregnancy test within 2 weeks prior to the start of treatment.\n* Signed informed consent.\n* Any relapsed AML after initial treatment according to a defined international AML protocol. (NOPHO-DBH AML 2012\u002Fnew protocol), or AML in first remission with transplant indications and treatment according to national AML protocol (NOPHO-DBH AML 2012 or new protocol).\n* In hematological remission, defined as:\n\n\\\u003C 5 % leukemic blasts confirmed by flow cytometry (in patients with an informative leukemia associated immunophenotype) in a bone marrow sample taken ≤14 days prior to start of conditioning and no evidence of extramedullary disease, including in CNS and no leukemic blasts in the peripheral blood (verified by flow cytometry in case immature cells are detected in the peripheral blood differential).\n\n-Patients must have a related or unrelated donor fulfilling any of the following criteria: HLA 10\u002F10 allelic matched, identical, sibling BM donor or HLA 10\u002F10 or 9\u002F10 allelic matched related\u002Funrelated BM or PBSC donor orHLA 5-6\u002F6 unrelated or 6-7-8\u002F8 unrelated Cord Blood (UCB)\n\nInclusion criteria for observation\u002Fregistration only:\n\n* Diagnosis of acute myeloid leukemia\n* Indication for allogeneic stem cell transplantation, as defined by primary treatment protocol or treating physician.\n* Age ≤18 years at time of initial AML, age ≤ 21 years at transplantation.\n* Not eligible for randomization, either due to lack of consent or not fulfilling inclusion criteria for interventional part of the study.\n* Signed informed consent to prospectively register follow-up data.\n\nExclusion criteria for the randomization part of the study :\n\n* Diagnosis of myelodysplastic syndrome (MDS).\n* Diagnosis of juvenile myelomonocytic leukemia (JMML).\n* History of previous malignancy (AML diagnosed as secondary cancer).\n* Known diagnosis of Fanconi anemia.\n* Prior autologous or allogeneic hematopoietic stem cell transplant.\n* Planned prophylactic DLI or other immunotherapeutic interventions after HCT that are not included in the upfront protocol, Planned anti-leukemic medication after HCT that are not included in the upfront protocol\n* Known intolerance to any of the chemotherapeutic drugs in the protocol.\n* Major organ failure precluding administration of planned chemotherapy.\n* Patients with uncontrolled bacterial, viral, or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.\n* Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion, e.g. malformation syndromes, cardiac malformations, metabolic disorders, renal impairment (\\\u003C30% of normal glomerular filtration rate), severe pulmonary, hepatic or cardiac impairment due to toxicity or infection.\n* Karnofsky \u002F Lansky score \\\u003C 50%\n* Females who are pregnant (positive serum or urine βHCG) or breastfeeding.\n* Females of childbearing potential or men who have sexual contact with females of childbearing potential unwilling to use effective forms of birth control or abstinence for one year after transplantation.\n* Subjects unwilling or unable to comply with the study procedures.\n\nExclusion criteria for the observational part of the study:\n\n* Diagnosis of Myelodysplastic syndrome (MDS).\n* Diagnosis of Juvenile myelomonocytic leukemia (JMML).\n* Age above 21 years at time of transplantation\n* No consent is given to prospectively register outcome data\n* Prior autologous or allogeneic hematopoietic stem cell transplant.","ALL","18 Years",{"count":376,"type":377},170,"ESTIMATED","INTERVENTIONAL",[380],"PHASE3","It is a randomized phase 3 study comparing two conditioning regimens in children with Acute Myeloid Leukemia, AML, undergoing allogenic stem cell transplantation. The primary aim is to investigate if a conditioning regimen containing one alkylator (Bu) combined with two antimetabolites (Clo and Flu) results in superior 2-year acute grade III to IV-free, chronic non-limited GvHD-free, relapse free survival than a conditioning regimen combining three alkylating agents (BuCyMel)",[383,384],"Acute Myeloid Leukemia (AML) in Remission","Stem Cell Transplantation",[386,387,388,389,390],"Leukemia","Leukemia, Myeloid, Acute","Neoplasms","Haematopoietic cell transplantation","Paediatric","2024-12-16",{"date":393,"type":394},"2024-12-19","ACTUAL",{"date":396,"type":394},"2022-06-07",{"date":398,"type":377},"2031-12-31",{"name":5,"class":6},17]