{"doi":"10.17615/603a-j634","title":"Phase I/II Trial of Dose-Escalated Busulfan Delivered by Prolonged Continuous Infusion in Allogeneic Transplant Patients","abstract":"Intensive chemotherapy or chemotherapy plus irradiation and allogeneic stem cell transplantation can be curative for patients with hematologic diseases. Reduced intensity transplants can also achieve cure, and result in less treatment related mortality but higher relapse rates. Thus, optimizing the conditioning regimens used in allogeneic transplantation remains an important goal. We conducted a Phase I/II trial to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of a continuous infusion of busulfan over 90 hours in conjunction with fludarabine followed by allogeneic related or unrelated donor transplant. Fifty-four patients with advanced hematologic malignancies were enrolled on this study. The MTD was identified as a 24 hour area under the curve (AUC) of approximately 7095 uMmin which represents a 43% increase over the standard total daily AUC dose of 4800 uMmin given by intermittent schedules. DLTs at doses over 8000 uMmin were identified as a desquamative skin rash and mucositis. No dose-related increase in hepatic, pulmonary or other organ toxicies were seen while efficacy appeared to be improved at higher dose levels. Continuous infusion busulfan with intermittent fludarabine provides an alternative treatment strategy that is generally well tolerated and permits an increase in total busulfan dose with encouraging efficacy.","journal":"UNC Libraries","year":2020,"id":139324,"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":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9545,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":520488,"name":"Stefanie Sarantopoulos","orcid":"0000-0003-4551-6687","position":1,"is_corresponding":false},{"id":389600,"name":"Thomas C. Shea","orcid":null,"position":2,"is_corresponding":false},{"id":602108,"name":"Christine M. Walko","orcid":"0000-0001-8435-898X","position":3,"is_corresponding":false},{"id":262408,"name":"Jonathan S. Serody","orcid":"0000-0003-4568-1092","position":4,"is_corresponding":false},{"id":363961,"name":"William A. Wood","orcid":"0000-0001-7439-2543","position":5,"is_corresponding":false},{"id":533104,"name":"Kamakshi V. Rao","orcid":"0000-0002-5621-2366","position":6,"is_corresponding":false},{"id":602678,"name":"Terry Comeau","orcid":null,"position":7,"is_corresponding":false},{"id":602679,"name":"Julia Sheets","orcid":null,"position":8,"is_corresponding":false},{"id":533107,"name":"James M. Coghill","orcid":"0000-0002-4736-0877","position":9,"is_corresponding":false},{"id":533106,"name":"Paul M. Armistead","orcid":"0000-0003-3983-5534","position":10,"is_corresponding":false},{"id":602680,"name":"Don G. Gabriel","orcid":null,"position":11,"is_corresponding":false},{"id":378763,"name":"Anastasia Ivanova","orcid":"0000-0003-4321-2073","position":12,"is_corresponding":false},{"id":593394,"name":"Yunro Chung","orcid":"0000-0001-9125-9277","position":0,"is_corresponding":true}],"reference_count":0,"raw_metadata":null,"created_at":"2026-07-18T23:17:10.185988Z","pmid":null,"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":[]}