{"doi":"10.1016/j.jtct.2023.06.008","title":"Phase II Study of Myeloablative 7-8/8-Matched Allotransplantation with Post-Transplantation Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil","abstract":"ABSTRACT Graft-versus-host disease (GVHD) is the major toxicity of allogeneic hematopoietic cell transplantation (HCT). We hypothesized that a GVHD prophylaxis regimen of post-transplantation cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF) would be associated with incidences of acute and chronic GVHD in patients receiving a matched or single antigen mismatched HCT. This Phase II study was conducted at the University of Minnesota using a myeloablative regimen of either total body irradiation (TBI) at a total dose of 1320 cGy, administered in 165-cGy fractions, twice daily from day -4 to day -1, or busulfan (Bu) 3.2 mg/kg daily (cumulative area under the curve, 19,000 to 21,000 μmol/min/L) plus fludarabine (Flu) 40 mg/m 2 once daily on days -5 to -2, followed by a GVHD prophylaxis regimen of PTCy 50 mg/kg on days +3 and +4, Tac, and MMF beginning on day +5. The primary endpoint was the cumulative incidence of chronic GVHD necessitating systemic immunosuppression (IST) at 1 year post-transplantation. Between March 2018 and May 2022, we enrolled 125 pediatric and adult patients, with a median follow-up of 813 days. The incidence of chronic GVHD necessitating systemic IST at 1 year was 5.5%. The rate of grade II-IV acute GVHD was 17.1%, and that of grade III-IV acute GVHD was 5.5%. Two-year overall survival was 73.7%, and 2-year graft-versus-host disease-free, relapse-free survival was 52.2%. The 2-year cumulative incidence of nonrelapse mortality was 10.2%, and the rate of relapse was 39.1%. There was no statistically significant difference in survival outcomes between recipients of matched donor transplants versus recipients of 7/8 matched donor transplants. Our data show that myeloablative HCT with PTCy/Tac/MMF results in an extremely low incidence of severe acute and chronic GVHD in well-matched allogeneic HCT.","journal":"Transplantation and Cellular Therapy","year":2023,"id":335401,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":20,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9608,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1028034,"name":"Alex Hoover","orcid":"0000-0002-2368-296X","position":1,"is_corresponding":false},{"id":356303,"name":"Daniel E. O’Leary","orcid":"0000-0002-5240-9516","position":2,"is_corresponding":false},{"id":488195,"name":"Qing Cao","orcid":"0000-0002-1523-8797","position":3,"is_corresponding":false},{"id":735927,"name":"Ashish O. Gupta","orcid":"0000-0001-5679-5533","position":4,"is_corresponding":false},{"id":545875,"name":"Christen L. Ebens","orcid":"0000-0003-2430-911X","position":5,"is_corresponding":false},{"id":414026,"name":"Joseph Maakaron","orcid":"0000-0002-1732-6694","position":6,"is_corresponding":false},{"id":196669,"name":"B Betts","orcid":"0000-0001-7643-2422","position":7,"is_corresponding":false},{"id":313704,"name":"Armin Rashidi","orcid":"0000-0002-9384-272X","position":8,"is_corresponding":false},{"id":708036,"name":"Mark Juckett","orcid":"0000-0003-2074-5678","position":9,"is_corresponding":false},{"id":298499,"name":"Troy C. Lund","orcid":"0000-0001-9174-8919","position":10,"is_corresponding":false},{"id":364551,"name":"Veronika Bachanová","orcid":"0000-0002-9325-432X","position":11,"is_corresponding":false},{"id":313706,"name":"Margaret L. MacMillan","orcid":"0000-0002-0755-0852","position":12,"is_corresponding":false},{"id":302950,"name":"Jeffrey S. Miller","orcid":"0000-0002-0339-4944","position":13,"is_corresponding":false},{"id":213483,"name":"Paul J. Orchard","orcid":"0000-0001-9426-1292","position":14,"is_corresponding":false},{"id":241241,"name":"John E. Wagner","orcid":"0000-0003-1996-6262","position":15,"is_corresponding":false},{"id":294764,"name":"Gregory M. Vercellotti","orcid":"0000-0003-1324-0831","position":16,"is_corresponding":false},{"id":122976,"name":"Daniel J. Weisdorf","orcid":"0000-0001-8078-8579","position":17,"is_corresponding":false},{"id":746846,"name":"Kathryn Dusenbery","orcid":null,"position":18,"is_corresponding":false},{"id":985838,"name":"Stephanie Terezakis","orcid":"0000-0002-8125-3987","position":19,"is_corresponding":false},{"id":292153,"name":"Shernan G. Holtan","orcid":"0000-0002-5054-9419","position":20,"is_corresponding":false},{"id":414022,"name":"Najla El Jurdi","orcid":"0000-0002-9268-9655","position":0,"is_corresponding":true}],"reference_count":25,"raw_metadata":null,"created_at":"2026-07-19T01:09:58.338267Z","pmid":"37311510","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}