protocolSection identificationModule nctId: NCT06299462, orgStudyIdInfo id: PTCy-ATG-001, briefTitle: PTCy and ATG for MSD and MUD Transplants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-21, primaryCompletionDateStruct date: 2031-06-01, completionDateStruct date: 2031-06-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Instituto Nacional de Cancer, Brazil, class: OTHER_GOV, descriptionModule briefSummary: 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).Since 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.This 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).Patients who are ready for transplantation with matched-sibling or unrelated donors will be recruited to participate in the study.The stem cell collection target will be 5E6 CD34/kg recipient weight for peripheral source. If a quantity greater than this is collected, the remainder will be cryopreserved according to the institutional protocol.Graft-versus-host disease prophylaxis will be performed on D+3 and D+4 with cyclophosphamide and with ATG on D-1 or on D-2 and D-1, depending on ATG de-escalation, for matched-sibling transplants, according to prespecified criteria based on the 3+3 approach; and on D+3 and D+4 with cyclophosphamide and with ATG on D-2 and D-1, for unrelated donors., conditionsModule conditions: Acute Myeloid Leukemia, conditions: Acute Lymphoblastic Leukemia, conditions: Myelodysplastic Syndromes, conditions: Hodgkin Lymphoma, conditions: Non-hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients with a matched sibling donor will be assigned to the PTCy+ATG2.5±1.5 arm, while patients with an matched unrelated donor will be assigned to the PTCy+ATG5.0 arm, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: ATG 5.0, interventions name: Cyclophosphamide injection, interventions name: ATG 2.5±1.5, outcomesModule primaryOutcomes measure: Cumulative incidence of grades III-IV acute GVHD by the MAGIC criteria, secondaryOutcomes measure: Cumulative incidence of grades II-IV acute GVHD by the MAGIC criteria, secondaryOutcomes measure: Cumulative incidence of steroid-refractory acute GVHD as defined by Mohty et al PMID 32756949, secondaryOutcomes measure: Cumulative incidence of chronic GVHD as defined by the NIH criteria, secondaryOutcomes measure: Cumulative incidence of steroid-requiring chronic GVHD as defined by the NIH criteria, secondaryOutcomes measure: Cumulative incidence of non-relapse mortality, i.e., death not following disease relapse, secondaryOutcomes measure: Cumulative incidence of relapse, defined as > 5% blasts in bone marrow or 1% blasts in peripheral blood (acute leukemias/myelodysplasia) or biopsy proven relapse or positve PET-CT (lymphoma), secondaryOutcomes measure: Rate of overall survival, secondaryOutcomes measure: Rate of disease-free survival (death or relapse), secondaryOutcomes measure: Cumulative incidence of clinically significant CMV reactivation (which led to antiviral treatment), secondaryOutcomes measure: Cumulative incidence of posttransplant lymphoproliferative disorder (biopsy-proven or positive EBV PCR combined with clinical symptoms), secondaryOutcomes measure: Cumulative incidence CMV disease (biopsy-proven CMV disease OR suggestive CMV+ BAL), secondaryOutcomes measure: Measuremnt of quality of life using the FACT-BMT scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-03-23, uploadDate: 2023-03-23T15:38, filename: Prot_SAP_000.pdf, size: 322979, hasResults: False