[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565770":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":30,"responsibleParty":369,"collaborators":11,"id":371,"slug":372,"hasResults":373,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":373,"sex":379,"minAge":380,"maxAge":381,"enrollmentInfo":382,"targetDuration":11,"studyType":385,"phases":386,"briefSummary":388,"conditions":389,"keywords":391,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":405},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Allogeneic hematopoietic stem cell transplantation Stem cell source only Bone Marrow","EXPERIMENTAL",null,[13],"Biological: Allogeneic hematopoietic stem cell transplantation Stem cell source only Bone Marrow",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"BIOLOGICAL","1. Conditioning regimen Thymoglobulin (0.5\u002Fmg\u002Fkg à D-9, 2 mg \u002Fkg at D-8 and 2.5 mg\u002Fkg à D-7), Fludarabine (30mg\u002Fm2\u002Fday i.v: day -6 to day -2), pre-transplant, Cyclophosphamide (14.5 mg\u002Fkg\u002Fday i.v: day -6 and day -5), and Total Body Irradiation (2 Gray on day -1).\n2. Stem cell source Bone Marrow only. Target of 4 × 10\\^8 nucleated cells\u002Fkg recipient body weight. Granulocyte colony stimulating factor is given subcutaneously starting on day +5 at 5 mg\u002F kg\u002Fday until the absolute neutrophil count is greater than 1.5 × 10\\^9\u002FL for 3 days.\n3. GVHD prophylaxis Cyclophosphamide 50 mg\u002FKg\u002Fday at D+3 and D+4. Tacrolimus (0,2 à 0,3 mg\u002Fkg\u002Fday per os divided into 2 doses or 0.05 to 0.1 mg\u002Fkg\u002Fd IVSE) and mycophenolate (MMF) will begin from D+5. In absence of GvHD, MMF will be stopped between D35 and D45 and Tacrolimus at day 365.\n4. Prevention of EBV reactivation Rituximab 150mg\u002Fm2 intravenously at Day+5 post HSCT (except patients and their donor with EBV serology and EBV PCR negative).",[9],[20,26],{"name":21,"role":22,"phone":23,"phoneExt":24,"email":25},"Régis Peffault de Latour, MD PhD","CONTACT","142385073","+33","regis.peffaultdelatour@aphp.fr",{"name":27,"role":22,"phone":28,"phoneExt":24,"email":29},"Jérôme Lambert, MD PhD","142499742","jerome.lambert@u-paris.fr",[31,48,61,74,87,100,114,127,140,153,166,180,193,206,219,232,245,258,271,281,291,304,317,330,343,356],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":35,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Saint Louis hospital","RECRUITING","Paris","France","75010","FR",{"type":39,"coordinates":40},"Point",[41,42],2.3488,48.85341,{"lat":42,"lon":41},[45],{"name":46,"role":22,"phone":47,"phoneExt":11,"email":11},"Régis Peffault de La Tour, MD 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Besançon","Besançon",{"type":39,"coordinates":78},[79,80],6.01815,47.24878,{"lat":80,"lon":79},[83],{"name":84,"role":22,"phone":85,"phoneExt":24,"email":86},"Etienne Daguindau","+33370632285","edaguindau@chu-besancon.fr",{"facility":88,"status":33,"city":89,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"CHU Bordeaux","Bordeaux",{"type":39,"coordinates":91},[92,93],-0.58046,44.84124,{"lat":93,"lon":92},[96],{"name":97,"role":22,"phone":98,"phoneExt":24,"email":99},"Edouard Forcade","+33 5 57 65 65 11","edouard.forcade@chu-bordeaux.fr",{"facility":101,"status":102,"city":103,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"CHU Caen","NOT_YET_RECRUITING","Caen",{"type":39,"coordinates":105},[106,107],-0.35912,49.18585,{"lat":107,"lon":106},[110],{"name":111,"role":22,"phone":112,"phoneExt":11,"email":113},"Sylvain Chantepie","+33231272073","Chantepie-s@chu-caen.fr",{"facility":115,"status":33,"city":116,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"HNIA Percy","Clamart",{"type":39,"coordinates":118},[119,120],2.26692,48.80299,{"lat":120,"lon":119},[123],{"name":124,"role":22,"phone":125,"phoneExt":24,"email":126},"Johanna Konopacki","+33 1 41 46 63 03","johanna.konopacki@intradef.gouv.fr",{"facility":128,"status":33,"city":129,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Hôpital d'Estaing","Clermont-Ferrand",{"type":39,"coordinates":131},[132,133],3.08682,45.77969,{"lat":133,"lon":132},[136],{"name":137,"role":22,"phone":138,"phoneExt":24,"email":139},"Aurélie Ravinet","+33 4 73 75 00 65","aravinet@chu-clermontferrant.fr",{"facility":141,"status":102,"city":142,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Hôpital Henri Mondor AP-HP","Créteil",{"type":39,"coordinates":144},[145,146],2.46569,48.79266,{"lat":146,"lon":145},[149],{"name":150,"role":22,"phone":151,"phoneExt":24,"email":152},"Sébastien Maury","+33 1 49 81 45 26","sebastien.maury@aphp.fr",{"facility":154,"status":33,"city":155,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"CHU Grenoble Alpes","Grenoble",{"type":39,"coordinates":157},[158,159],5.71479,45.17869,{"lat":159,"lon":158},[162],{"name":163,"role":22,"phone":164,"phoneExt":24,"email":165},"Claude-Eric Bulabois","+33 4 76 76 92 09","cebulabois@chu-grenoble.fr",{"facility":167,"status":102,"city":168,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"CHU Lille","Lille",{"type":39,"coordinates":170},[171,172],3.05512,50.63391,{"lat":172,"lon":171},[175,178],{"name":176,"role":22,"phone":11,"phoneExt":11,"email":177},"Micha Srour","Micha.SROUR@chu-lille.fr",{"name":176,"role":22,"phone":179,"phoneExt":24,"email":177},"+33 3 20 44 42 85",{"facility":181,"status":33,"city":182,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"CHU Limoges","Limoges",{"type":39,"coordinates":184},[185,186],1.24759,45.83362,{"lat":186,"lon":185},[189],{"name":190,"role":22,"phone":191,"phoneExt":24,"email":192},"Pedro de Lima Prata","+33 5 55 05 88 67","Pedro.PRATA@chu-limoges.fr",{"facility":194,"status":33,"city":195,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"CHU Lyon Sud","Lyon",{"type":39,"coordinates":197},[198,199],4.84789,45.74906,{"lat":199,"lon":198},[202],{"name":203,"role":22,"phone":204,"phoneExt":24,"email":205},"Vincent Alcazer","+33 4 78 86 22 59","vincent.alcazer@chu-lyon.fr",{"facility":207,"status":102,"city":208,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Institut Paoli Calmettes","Marseille",{"type":39,"coordinates":210},[211,212],5.38107,43.29695,{"lat":212,"lon":211},[215],{"name":216,"role":22,"phone":217,"phoneExt":11,"email":218},"Raynier Devillier","+33 4 91 22 33 33","DEVILLIERR@ipc.unicancer.fr",{"facility":220,"status":33,"city":221,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"CHU Montpellier","Montpellier",{"type":39,"coordinates":223},[224,225],3.87635,43.61093,{"lat":225,"lon":224},[228],{"name":229,"role":22,"phone":230,"phoneExt":24,"email":231},"Patrice Ceballos","+33 4 67 33 32 68","p-ceballos@chu-montpellier.fr",{"facility":233,"status":33,"city":234,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"CHRU Nancy","Nancy",{"type":39,"coordinates":236},[237,238],6.18496,48.68439,{"lat":238,"lon":237},[241],{"name":242,"role":22,"phone":243,"phoneExt":24,"email":244},"Simona Pagliuca","+33383155259","s.pagliuca@chru-nancy.fr",{"facility":246,"status":33,"city":247,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"CHU Nantes","Nantes",{"type":39,"coordinates":249},[250,251],-1.55336,47.21725,{"lat":251,"lon":250},[254],{"name":255,"role":22,"phone":256,"phoneExt":24,"email":257},"Alice Garnier","+33 2 40 08 42 28","alice.garnier@chu-nantes.fr",{"facility":259,"status":33,"city":260,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"CHU Nice","Nice",{"type":39,"coordinates":262},[263,264],7.26608,43.70313,{"lat":264,"lon":263},[267],{"name":268,"role":22,"phone":269,"phoneExt":24,"email":270},"Michael Loschi","+33 4 92 03 52 11","loschi.m@chu-nice.fr",{"facility":272,"status":33,"city":34,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":273,"geoPoint":275,"contacts":276},"Hopital Necker - APHP",{"type":39,"coordinates":274},[41,42],{"lat":42,"lon":41},[277],{"name":278,"role":22,"phone":279,"phoneExt":24,"email":280},"Felipe Suarez","+331 44 49 51 88","felipe.suarez@aphp.fr",{"facility":282,"status":102,"city":34,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":283,"geoPoint":285,"contacts":286},"Hôpital La Pitié Salpêtrière AP-HP",{"type":39,"coordinates":284},[41,42],{"lat":42,"lon":41},[287],{"name":288,"role":22,"phone":289,"phoneExt":24,"email":290},"Stéphanie Nguyen-Quoc","+33 1 42 17 61 84","stephanie.nguyen-quoc@aphp.fr",{"facility":292,"status":33,"city":293,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"CHU Poitiers","Poitiers",{"type":39,"coordinates":295},[296,297],0.34348,46.58261,{"lat":297,"lon":296},[300],{"name":301,"role":22,"phone":302,"phoneExt":11,"email":303},"Natacha Maillard","+33 5 16 60 43 29","natacha.maillard@chu-poiters.fr",{"facility":305,"status":102,"city":306,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":307,"geoPoint":311,"contacts":312},"CHU Rennes","Rennes",{"type":39,"coordinates":308},[309,310],-1.67431,48.11109,{"lat":310,"lon":309},[313],{"name":314,"role":22,"phone":315,"phoneExt":24,"email":316},"Jean-Baptiste Mear","+33299284321","jean-baptiste.mear@chu-rennes.fr",{"facility":318,"status":102,"city":319,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"Henri Becquerel","Rouen",{"type":39,"coordinates":321},[322,323],1.09932,49.44313,{"lat":323,"lon":322},[326],{"name":327,"role":22,"phone":328,"phoneExt":24,"email":329},"Anne-Lise Menard","+33 2.32.08.24.98","anne-lise.menard@chb-unicancer.fr",{"facility":331,"status":33,"city":332,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":333,"geoPoint":337,"contacts":338},"CHU Saint Etienne","Saint-Etienne",{"type":39,"coordinates":334},[335,336],4.39,45.43389,{"lat":336,"lon":335},[339],{"name":340,"role":22,"phone":341,"phoneExt":24,"email":342},"Jérôme Cornillon","+334 77 82 24 55","Jerome.Cornillon@chu-st-etienne.fr",{"facility":344,"status":33,"city":345,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":346,"geoPoint":350,"contacts":351},"CHU Strasbourg","Strasbourg",{"type":39,"coordinates":347},[348,349],7.74553,48.58392,{"lat":349,"lon":348},[352],{"name":353,"role":22,"phone":354,"phoneExt":24,"email":355},"Bruno Lioure","+33 3 68 76 74 03","bruno.lioure@chru-strasbourg.fr",{"facility":357,"status":33,"city":358,"state":11,"zip":11,"country":35,"countryCode":37,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"CHU Toulouse","Toulouse",{"type":39,"coordinates":360},[361,362],1.44367,43.60426,{"lat":362,"lon":361},[365],{"name":366,"role":22,"phone":367,"phoneExt":24,"email":368},"Anne Huynh","+33 5 31 15 63 31","huynh.anne@iuct-oncopole.fr",{"type":370,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100565770","phase-2-indication-of-hsct-in-patients-with-refractoryrelapse-aa-after-first-line-standard-immunosuppressive-therapy-aged-more-than-40-years-100565770",false,"NCT06646497","Indication of HSCT in Patients With Refractory\u002FRelapse AA After First-line Standard Immunosuppressive Therapy Aged More Than 40 Years","Evaluation of an Optimized Allogeneic Hematopoietic Stem Cell Transplantation Protocol With Post-transplant Cyclophosphamide in Patients Aged 40 to 60 Years Old With Acquired Aplastic Anemia Refractory or in Relapse After Immunosuppression","APARR","Inclusion Criteria:\n\n* Aged from 40 to 60 years old\n* Suffering from acquired refractory severe idiopathic aplastic anemia after at least 6 months treatment with anti-thymocyte globulin, cyclosporine with Eltrombopag or in relapse\n* Allograft validated in the National Multidisciplinary expertise meetings of the French reference centre for aplastic anemia\n* With an available geno-identical donor or 10\u002F10 matched donor or haploidentical donor\n* With the absence of donor specific antibody detected in the patient with a MFI \\\u003C 1500 (antibodies to the distinct haplotype between donor and recipient)\n* Usual criteria for HSCT:\n\n  * ECOG ≤ 2\n  * No severe and uncontrolled infection\n  * Cardiac function compatible with high dose of cyclophosphamide\n  * With an adequate organ function ASAT and ALAT ≤ 3N, conjugated bilirubin ≤ 2N (or total bilirubin ≤ 2N if not available), clearance creatinine ≥ 50ml \u002F min\n* With health insurance coverage\n* Women of childbearing potential and men must use contraceptive methods during their participation to the research and for 12 months and 6 months after the last dose of cyclophosphamide, respectively.\n* Having signed a written informed consent\n\nNB: The authorized contraceptive methods are: For women of childbearing age and in absence of permanent sterilization:\n\n* oral, intravaginal or transdermal combined hormonal contraception,\n* oral, injectable or transdermal progestogen-only hormonal contraception,\n* intrauterine hormonal-releasing system (IUS),\n* sexual abstinence (need to be evaluated in relation to the duration of clinical trial and the preferred and usual lifestyle of the participants).\n\nFor men in absence of permanent sterilization: sexual abstinence, condoms.\n\nIndividuals must meet all of the inclusion criteria as verified at the screening \u002F inclusion visit to be eligible to participate at the study.\n\nExclusion Criteria:\n\nPatients:\n\n* With morphologic evidence of clonal evolution (patients with isolated bone marrow cytogenetic abnormalities are also eligible excepted chromosome 7 abnormalities and complex karyotype).\n* With seropositivity for HIV or HTLV-1-2 or active hepatitis B or C and associated hepatic cytolysis\n* Cancer in the last 5 years (except basal cell carcinoma of the skin or \"in situ\" carcinoma of the cervix)\n* Pregnant (βHCG positive) or breast-feeding\n* Yellow fever vaccine and all others live virus vaccines within 2 months before transplantation and during the research\n* With uncontrolled coronary insufficiency, recent myocardial infarction \\\u003C 6-month, current manifestations of heart failure according to NYHA (II or more), ventricular ejection fraction \\\u003C50%\n* With renal failure with creatinine clearance \\\u003C50ml \u002Fmin\n* Any contraindication mentioned in the SmPC and the Investigator's brochure of all medicinal products planned to be used in the trial including conditioning regimen, GVHD prophylaxis, prevention of EBV reactivation, infection prophylaxis\n* Known allergy or intolerance to all medicinal products and\u002For excipients planned to be used in the trial including conditioning regimen, GVHD prophylaxis, prevention of EBV reactivation, infection prophylaxis, according to Investigator's brochure and SmPC.\n* Who have any debilitating medical or psychiatric illness, which precludes understanding the inform consent as well as optimal treatment and follow-up\n* Under legal protection (tutorship or curatorship)\n* Under state medical aid\n* Participation to another interventional trial on a medicinal product or cell therapy\n\nIndividuals meeting any of the exclusion criteria as verified at the screening \u002F inclusion visit will be ineligible to participate at the study.","ALL","40 Years","60 Years",{"count":383,"type":384},52,"ESTIMATED","INTERVENTIONAL",[387],"PHASE2","Outcomes for adult patients with Severe Aplastic Anemia (SAA) aged more than 40 years who are refractory or in relapse after first-line IST remain poor. Hematopoietic stem cell transplantation (HSCT) is the unic valid therapeutic option but results have always been disappointing in patients aged 40 years or older. The first cause of death after HSCT in those refractory\u002Frelapse SAA patients is still graft versus host disease (GvHD). Recently, new strategies to prevent GvHD, including T-cell replete grafts with administration of post-transplantation cyclophosphamide (PTCy), have revolutionized the field, notably in haplo-identical donor setting. Using marrow as source of stem cells and a PTCy strategy not only in haplo-identical donor setting but also in case of an available matched sibling or unrelated donor might prevent drastically GvHD and eventually be practice changing. Evaluating this new strategy is the main objectives of \"APARR\".",[390],"Aplastic Anemia",[392,393,394,395],"Refractory\u002Frelapse idiopathic anemia","Idiopathic aplastic anemia","Hematopoietic stem cell transplantation","Post-transplantation cyclophosphamide","2026-04-27",{"date":398,"type":399},"2026-04-28","ACTUAL",{"date":401,"type":399},"2025-01-24",{"date":403,"type":384},"2030-01-24",{"name":5,"class":6},26]