[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539101":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":53,"studyPopulation":53,"armGroups":61,"interventions":74,"overallOfficials":88,"centralContacts":93,"locations":98,"responsibleParty":119,"collaborators":53,"id":121,"slug":53,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":53,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":53,"studyType":133,"phases":134,"briefSummary":137,"conditions":138,"keywords":144,"overallStatus":100,"whyStopped":53,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Instituto Nacional de Cancer, Brazil","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":53},[9],{"measure":10,"description":11,"timeFrame":12},"Cumulative incidence of grades III-IV acute GVHD by the MAGIC criteria","Cumulative incidence of acute graft-versus-host disease, grades III-IV by the MAGIC criteria","6 months",[14,17,20,24,27,30,33,36,39,43,46,49],{"measure":15,"description":16,"timeFrame":12},"Cumulative incidence of grades II-IV acute GVHD by the MAGIC criteria","Cumulative incidence of acute graft-versus-host disease, grades II-IV by the MAGIC criteria",{"measure":18,"description":19,"timeFrame":12},"Cumulative incidence of steroid-refractory acute GVHD as defined by Mohty et al PMID 32756949","Cumulative incidence of steroid-refractory graft-versus-host disease",{"measure":21,"description":22,"timeFrame":23},"Cumulative incidence of chronic GVHD as defined by the NIH criteria","Cumulative incidence of chronic graft-versus-host disease","3 years",{"measure":25,"description":26,"timeFrame":23},"Cumulative incidence of steroid-requiring chronic GVHD as defined by the NIH criteria","Cumulative incidence of steroid-requiring chronic graft versus host disease",{"measure":28,"description":29,"timeFrame":23},"Cumulative incidence of non-relapse mortality, i.e., death not following disease relapse","Cumulative incidence of death not caused by primary malignant disease or following relapse",{"measure":31,"description":32,"timeFrame":23},"Cumulative incidence of relapse, defined as > 5% blasts in bone marrow or 1% blasts in peripheral blood (acute leukemias\u002Fmyelodysplasia) or biopsy proven relapse or positve PET-CT (lymphoma)","Cumulative incidence of relapse of primary malignant disease",{"measure":34,"description":35,"timeFrame":23},"Rate of overall survival","Death by any cause",{"measure":37,"description":38,"timeFrame":23},"Rate of disease-free survival (death or relapse)","Composite outcome of death or primary disease relapse",{"measure":40,"description":41,"timeFrame":42},"Cumulative incidence of clinically significant CMV reactivation (which led to antiviral treatment)","Incidence of cytomegalovirus reactivation","3 year",{"measure":44,"description":45,"timeFrame":23},"Cumulative incidence of posttransplant lymphoproliferative disorder (biopsy-proven or positive EBV PCR combined with clinical symptoms)","Incidence of posttransplant lymphoproliferative disorder",{"measure":47,"description":48,"timeFrame":23},"Cumulative incidence CMV disease (biopsy-proven CMV disease OR suggestive CMV+ BAL)","Cumulative incidence of cytomegalovirus disease",{"measure":50,"description":51,"timeFrame":52},"Measuremnt of quality of life using the FACT-BMT scale","Measurement quality of life","2 years",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":57,"primaryPurpose":58,"observationalModel":53,"timePerspective":53,"maskingInfo":59},"NON_RANDOMIZED","PARALLEL","Patients with a matched sibling donor will be assigned to the PTCy+ATG4.l0 arm, while patients with a matched unrelated donor will be assigned to the PTCy+ATG5.0 arm","PREVENTION",{"masking":60,"maskingDescription":53,"whoMasked":53},"NONE",[62,69],{"label":63,"type":64,"description":65,"interventionNames":66},"Matched-sibling donor transplants","EXPERIMENTAL","Matched sibling transplants will receive PTCy + ATG4.0",[67,68],"Drug: Cyclophosphamide injection","Drug: ATG 4.0",{"label":70,"type":64,"description":71,"interventionNames":72},"Matched unrelated donor transplants","Unrelated transplants will receive PTCy + ATG5.0",[73,67],"Drug: ATG 5.0",[75,80,84],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":53},"DRUG","ATG 5.0","ATG 2.5 mg\u002Fkg on days -3 and -2",[70],{"type":76,"name":81,"description":82,"armGroupLabels":83,"otherNames":53},"Cyclophosphamide injection","Cyclophosphamide 50 mg\u002Fkg on days +3 and +4",[70,63],{"type":76,"name":85,"description":86,"armGroupLabels":87,"otherNames":53},"ATG 4.0","ATG 2.5 mg\u002Fkg on day -2 + 1.5 mg\u002Fkg on day -3",[63],[89],{"name":90,"affiliation":91,"role":92},"Leonardo J Arcuri, MD, PhD","Instituto Nacional de Cancer","PRINCIPAL_INVESTIGATOR",[94],{"name":90,"role":95,"phone":96,"phoneExt":53,"email":97},"CONTACT","+5521981334715","leonardojavier@gmail.com",[99],{"facility":91,"status":100,"city":101,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"RECRUITING","Rio de Janeiro","20230-130","Brazil","BR",{"type":106,"coordinates":107},"Point",[108,109],-43.18223,-22.90642,{"lat":109,"lon":108},[112,115],{"name":113,"role":95,"phone":114,"phoneExt":53,"email":97},"Leonardo J Arcuri, MD","+55(21)3207-1304",{"name":116,"role":95,"phone":117,"phoneExt":53,"email":118},"Simone Lermontov","+55(21)3207-1261","simonelermontov@globo.com",{"type":120,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","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":131,"type":132},50,"ESTIMATED","INTERVENTIONAL",[135,136],"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.",[139,140,141,142,143],"Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Myelodysplastic Syndromes","Hodgkin Lymphoma","Non-hodgkin Lymphoma",[145,146,147,148],"posttransplant cyclophosphamide","ATG","calcineurin-free GVHD prophylaxis","graft-versus-host disease","2025-02-21",{"date":151,"type":152},"2025-02-25","ACTUAL",{"date":154,"type":152},"2024-06-14",{"date":156,"type":132},"2031-06-01",{"name":5,"class":6},1]