[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539101":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":45,"responsibleParty":66,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":26,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":85,"conditions":86,"keywords":92,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Instituto Nacional de Cancer, Brazil","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Matched-sibling donor transplants","EXPERIMENTAL","Matched sibling transplants will receive PTCy + ATG4.0",[13,14],"Drug: Cyclophosphamide injection","Drug: ATG 4.0",{"label":16,"type":10,"description":17,"interventionNames":18},"Matched unrelated donor transplants","Unrelated transplants will receive PTCy + ATG5.0",[19,13],"Drug: ATG 5.0",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","ATG 5.0","ATG 2.5 mg\u002Fkg on days -3 and -2",[16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Cyclophosphamide injection","Cyclophosphamide 50 mg\u002Fkg on days +3 and +4",[16,9],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"ATG 4.0","ATG 2.5 mg\u002Fkg on day -2 + 1.5 mg\u002Fkg on day -3",[9],[36],{"name":37,"affiliation":38,"role":39},"Leonardo J Arcuri, MD, PhD","Instituto Nacional de Cancer","PRINCIPAL_INVESTIGATOR",[41],{"name":37,"role":42,"phone":43,"phoneExt":26,"email":44},"CONTACT","+5521981334715","leonardojavier@gmail.com",[46],{"facility":38,"status":47,"city":48,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Rio de Janeiro","20230-130","Brazil","BR",{"type":53,"coordinates":54},"Point",[55,56],-43.18223,-22.90642,{"lat":56,"lon":55},[59,62],{"name":60,"role":42,"phone":61,"phoneExt":26,"email":44},"Leonardo J Arcuri, MD","+55(21)3207-1304",{"name":63,"role":42,"phone":64,"phoneExt":26,"email":65},"Simone Lermontov","+55(21)3207-1261","simonelermontov@globo.com",{"type":67,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100539101","phase-1-ptcy-and-atg-for-msd-and-mud-transplants-100539101",false,"NCT06299462","PTCy and ATG for MSD and MUD Transplants","Efficacy Evaluation of Post-transplant Cyclophosphamide-based Graft-versus-host Disease Prophylaxis with ATG, Calcineurin Inhibitor-free, for Matched-sibling or Matched-unrelated Transplantation","Inclusion Criteria:\n\n* Patient with (1) acute leukemia in first or second remission; (2) myelodysplasia with less than 20% blasts; (3) Hodgkin's or non-Hodgkin's lymphoma, in partial remission after salvage therapy\n* Who will receive a related or unrelated, HLA-compatible transplant;\n* Who is a transplant candidate with FluMel, FluTBI, CyTBI, BuCy or BuFlu conditioning;\n* Peripheral blood source;\n* Age between 18 and 60 years.\n\nExclusion Criteria:\n\n\\- Hepatic dysfunction (transaminases x2 the normal value)","ALL","18 Years","60 Years",{"count":79,"type":80},50,"ESTIMATED","INTERVENTIONAL",[83,84],"PHASE1","PHASE2","Hematopoietic stem cell transplantation is a curative treatment for a number of benign and malignant hematologic diseases. One of the key parts of hematopoietic stem cell transplantation is the prophylaxis of graft-versus-host disease. Since the end of the 1970s, with the introduction of cyclosporine, calcineurin inhibitors (cyclosporine and tacrolimus) have become part of almost all prophylactic regimens, even though they are a group of drugs with a poor toxicity profile that requires monitoring. constant serum level. Since 2008, post-transplant cyclophosphamide has been introduced with great success, associated with a calcineurin inhibitor and mycophenolate, in the prophylaxis of graft-versus-host disease in haploidentical transplantation (50% matched).\n\nSince then, in view of this enormous success, efforts have been made to incorporate post-transplant cyclophosphamide in matched related and unrelated transplants, or with a mismatch.\n\nThis is a prospective, 2-arm, non-randomized study. Arm 1, with related donors, and arm 2, with unrelated donors. Patients will be allocated in these arms according to donor availability (patients with a matched-sibling donor will receive a matched-sibling transplant; patients with no related donors but with unrelated donors, an unrelated transplant).\n\nPatients who are ready for transplantation with matched-sibling or unrelated donors will be recruited to participate in the study.\n\nThe stem cell collection target will be 5E6 CD34\u002Fkg recipient weight for peripheral source. If a quantity greater than this is collected, the remainder will be cryopreserved according to the institutional protocol.\n\nGraft-versus-host disease prophylaxis will be performed on D+3 and D+4 with cyclophosphamide and with ATG on D-3 and D-2 for matched-sibling or unrelated donors transplants.",[87,88,89,90,91],"Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Myelodysplastic Syndromes","Hodgkin Lymphoma","Non-hodgkin Lymphoma",[93,94,95,96],"posttransplant cyclophosphamide","ATG","calcineurin-free GVHD prophylaxis","graft-versus-host disease","2025-02-21",{"date":99,"type":100},"2025-02-25","ACTUAL",{"date":102,"type":100},"2024-06-14",{"date":104,"type":80},"2031-06-01",{"name":5,"class":6},1]