[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535518":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":100,"centralContacts":108,"locations":115,"responsibleParty":155,"collaborators":54,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":159,"sex":165,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":54,"studyType":171,"phases":172,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":118,"whyStopped":54,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",[8,23],{"label":9,"type":10,"description":11,"interventionNames":12},"(CLO)-BALTIMORE","EXPERIMENTAL","BALTIMORE conditioning regime for LYMPHOID HEMOPATHY CLO-BALTIMORE conditioning regime for MYELOID HEMOPATHY",[13,14,15,16,17,18,19,20,21,22],"Drug: Methotrexate","Drug: Post-Transplant Cyclophosphamide","Drug: Fludarabine","Drug: Cycophosphamide","Drug: Anti-Thymoglobulin","Radiation: total body irradiation","Other: hematopoietic stem cells","Other: Graft nuclear cells","Other: Donor Lymphocytes Injection","Drug: Clofarabine",{"label":24,"type":25,"description":26,"interventionNames":27},"TBF","ACTIVE_COMPARATOR","Conditioning regimen for LYMPHOID AND MYELOID HEMOPATHY",[13,14,17,19,20,21,28,29,15],"Drug: Thiotepa","Drug: Busulfan",[31,38,44,50,55,61,68,74,78,84,87,91,95],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Methotrexate","15 mg\u002Fm² on Day+1 after graft (=Day0) 10 mg\u002Fm² 3 days on Day+4\u002FDay+6\u002FDay+11 after graft (=Day0)",[9,24],[37],"MTX",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Post-Transplant Cyclophosphamide","50 mg\u002Fkg intravenous 2 days on Day+3\u002FDay+5 after graft (=Day0)",[9,24],[43],"CY",{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Fludarabine","Conditioning regimen: 30 mg\u002Fm² Intravenous 5 days from Day-6 to Day-2 (Day-6\u002FDay-5-\u002FDay-4\u002FDay-3\u002FDay-2 before graft (=Day0)",[9],[49],"Fludarabine Baltimore",{"type":32,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Cycophosphamide","Conditioning regimen: 14.5 mg\u002Fkg intravenous 2 days on Day-6\u002FDay-5 before graft (=Day0)",[9],null,{"type":32,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Anti-Thymoglobulin","Conditioning regimen: 2.5 mg\u002Fkg intravenous on Day-2 before graft (=Day0)",[9,24],[60],"ATG",{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"RADIATION","total body irradiation","2 grays on Day-1 before graft (=Day0)",[9],[67],"TBI",{"type":6,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"hematopoietic stem cells","High dose of hematopoietic stem cells derived from peripheral blood on transplantation day (=Day0 graft)",[9,24],[73],"HSC",{"type":6,"name":75,"description":76,"armGroupLabels":77,"otherNames":54},"Graft nuclear cells","Graft nuclear cells CD3+ cells if needed after transplantation",[9,24],{"type":6,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"Donor Lymphocytes Injection","DLI with CD3+ if relapse after transplantation or in prevention of relapse",[9,24],[83],"DLI",{"type":32,"name":85,"description":46,"armGroupLabels":86,"otherNames":54},"Clofarabine",[9],{"type":32,"name":88,"description":89,"armGroupLabels":90,"otherNames":54},"Thiotepa","Conditioning regimen: 5 mg\u002Fkg Intravenous at Day-6 before graft (=Day0)",[24],{"type":32,"name":92,"description":93,"armGroupLabels":94,"otherNames":54},"Busulfan","Conditioning regimen: 3.2 mg\u002Fkg Intravenous 2 days at Day-2 and Day-1 before graft (=Day0)",[24],{"type":32,"name":45,"description":96,"armGroupLabels":97,"otherNames":98},"Conditioning regimen: 40 mg\u002Fm² intravenous 4 days on Day-5\u002FDay-4\u002FDay-3\u002FDay-2 before graft (=Day0)",[24],[99],"Fludarabine TBF",[101,105],{"name":102,"affiliation":103,"role":104},"Sylvain THEPOT, MD","University Hospital, Angers","PRINCIPAL_INVESTIGATOR",{"name":106,"affiliation":107,"role":104},"Marie-Anne COUTURIER, MD","University Hospital, Brest",[109],{"name":110,"role":111,"phone":112,"phoneExt":113,"email":114},"Amandine LE BOURGEOIS, MD","CONTACT","02 40 08 32 71","+33","amandine.lebourgeois@chu-nantes.fr",[116,132,144],{"facility":117,"status":118,"city":119,"state":54,"zip":54,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":127,"contacts":128},"CHU Angers","RECRUITING","Angers","France","FR",{"type":123,"coordinates":124},"Point",[125,126],-0.55202,47.47156,{"lat":126,"lon":125},[129],{"name":102,"role":111,"phone":130,"phoneExt":113,"email":131},"0241354482","sylvain.thepot@chu-angers.fr",{"facility":133,"status":118,"city":134,"state":54,"zip":54,"country":120,"countryCode":121,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"CHU Brest","Brest",{"type":123,"coordinates":136},[137,138],-4.48628,48.39029,{"lat":138,"lon":137},[141],{"name":106,"role":111,"phone":142,"phoneExt":113,"email":143},"0298223765","marie-anne.couturier@chu-brest.fr",{"facility":145,"status":118,"city":146,"state":54,"zip":54,"country":120,"countryCode":121,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"CHU Nantes","Nantes",{"type":123,"coordinates":148},[149,150],-1.55336,47.21725,{"lat":150,"lon":149},[153],{"name":110,"role":111,"phone":154,"phoneExt":113,"email":114},"0240083271",{"type":156,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR","100535518","phase-2-study-testing-two-conditioning-regimen-with-a-single-prophylaxis-of-gvhd-by-cyclophosphamide-and-methotrexate-post-transplant-in-patients-eligible-for-matched-donor-allograft-transplantation-100535518",false,"NCT06252870","Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-transplant in Patients Eligible for Matched-donor Allograft Transplantation","Randomized Phase 2 Study Testing Two Conditioning Regimen With a Single Prophylaxis of Graft-versus-host Disease by Cyclophosphamide and Methotrexate Post-transplant in Patients Eligible for Matched-donor Allograft Transplantation","CY-MET-RIC","Inclusion Criteria:\n\n* Age: ≥ 18 and ≤ 70 years old\n* Patient with hematologic malignancy\n* Indication for HSC allograft with attenuated conditioning\n* Pluripotent stem cell (PSC) engraftment\n* Availability of a 10\u002F10 familial or non-familial HLA compatible donor\n* Consent to the protocol\n* ECOG \\\u003C=2\n* Woman of childbearing age with negative pregnancy test and on highly effective contraception during treatment and for a period of 12 months after stopping MTX and CY\n* Man of childbearing age with highly effective contraception during treatment and for a period of 6 months after stopping MTX and CY and a period of 12 months after stopping MTX and CY if TBF conditioning regimen arm\n* Negative Hepatitis B, C, HIV serologies\n* Social security affiliation\n\nExclusion Criteria:\n\n* History of allograft\n* Patient eligible for myeloablative conditioning (MAC)\n* Bone marrow transplant\n* Other progressive cancerous disease, or antecedent of cancer in the last five years, with the exception of a carcinoma of the skin or a carcinoma in situ of the uterine cole treated and in remission.\n* Progressive psychiatric condition\n* Pregnant or breastfeeding woman,\n* Woman or man of childbearing age with lack of effective contraception\n* Serious and uncontrolled concomitant infection\n* Cardiac: systolic ejection fraction \\\u003C 50% by transthoracic ultrasound or by isotopic method (isotope gamma angiography), NYHA II, III or IV heart failure, active rhythmic, valvular or ischemic heart disease or anteriority\n* Respiratory with EFR: DLCOc \\\u003C40% of theoretical\n* Renal: creatinine clearance \\\u003C 50 ml\u002Fmin (assessment with MDRD method)\n* Urological: active urinary tract infection, history of acute urothelial toxicity due to cytotoxic chemotherapy or radiotherapy, known obstruction of urinary flow, pre-existing hemorrhagic cystitis\n* Hepatic: transaminases greater than 5 times normal or bilirubin greater than 2 times normal\n* Person protected by law (major under guardianship, curatorship or legal protection)\n* Vaccination against yellow fever in the last year\n* Known or suspected hypersensitivity to rabbit proteins as well as to the active substance and excipients of all investigational and ancillary drugs administered during the study,\n* Contraindication to any of the investigational or adjuvant drugs administered during the study\n* Patient not speaking French","ALL","18 Years","70 Years",{"count":169,"type":170},82,"ESTIMATED","INTERVENTIONAL",[173],"PHASE2","Graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation (allo-CSH).\n\nRecently, in the context of semi-identical (=haploidentical) HLA donors, but also of compatible HLA donors, the use of cyclophosphamide (CY) administered in high doses at early post-transplant (PT) (=PTCY) (Days +3 and +4 or +5) has shown excellent control of acute and chronic GVH, even enabling the discontinuation of other immunosuppressive drugs administered after allo-CSH (ciclosporin, mycophenolate mofetyl (MMF) or Cellcept).\n\nThis step has already been taken in the context of allo-CSH with myeloablative conditioning (MAC), which is a minoritary conditioning in adults.\n\nHowever, in the context of allo-CSH with reduced-intensity conditioning (RIC), which predominates in adults, this strategy seems insufficient to prevent the risk of GVHD.\n\nThe idea of reducing the use of immunosuppressants in the context of RIC\u002FHLA-compatible transplants seems, however, still relevant, in order to reduce their adverse effects, improve patients' quality of life and enhance the reconstitution of the post-transplant immune system.",[176,177],"Graft Versus Host Disease","Hematologic Malignancy",[179,180,181],"Hematopoietic stem cell allograft (Allo-CSH)","Methotrexate (MTX)","Post-transplant cyclophosphamide (PTCY)","2026-01-23",{"date":184,"type":185},"2026-01-26","ACTUAL",{"date":187,"type":185},"2024-07-18",{"date":189,"type":170},"2028-07-18",{"name":5,"class":6},3]