Hospitalization and Healthcare Resource Utilization of Omidubicel-Onlv versus Umbilical Cord Blood Transplantation for Hematologic Malignancies: Secondary Analysis from a Pivotal Phase 3 Clinical Trial

• Published in: Transplantation and cellular therapy 2023-12, Vol.29 (12), p.749.e1-749.e5
• Main Authors: Majhail, Navneet S., Miller, Beckley, Dean, Rebecca, Manghani, Rocio, Shin, Heayoung, Sivaraman, Smitha, Maziarz, Richard T.
• Format: Article
• Language: English
• Subjects: Adult; Allogeneic transplantation; Clinical Trials, Phase III as Topic; Cord blood stem cell transplantation; Cord Blood Stem Cell Transplantation - adverse effects; Delivery of Health Care; Female; Health resource utilization; Health services research; Hematologic Neoplasms - therapy; Hematopoietic Stem Cell Transplantation - adverse effects; Hospital length of stay; Hospitalization; Humans; Male; Omidubicel-onlv; Prospective Studies; Randomized Controlled Trials as Topic
• ISSN: 2666-6367; 2666-6367
• DOI: 10.1016/j.jtct.2023.09.004

•Umbilical cord blood transplantation is associated with high healthcare resource demands.•A phase 3 trial of omidubicel-onlv showed rapid hematopoietic and immune recovery.•Omidubicel-onlv was associated with reduced resource use at 100 days post-transplantation. A phase 3 trial (ClincialTrials.gov identifier NCT02730299) of omidubicel-onlv, a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy manufactured from a single umbilical cord blood (UCB) unit, showed faster hematopoietic recovery, reduced rate of infections, and shorter hospital stay compared with patients randomized to standard UCB. This prospective secondary analysis of the phase 3 trial characterized resource utilization in the first 100 days post-transplantation with omidubicel-onlv compared with UCB. This analysis examined resource utilization, including hospital length of stay, hospital care setting, visits by provider type, rate of transfusions, and readmissions, among the 108 treated patients (omidubicel-onlv, n = 52; UCB, n = 56) from day 0 to day 100 post-transplantation. Demographics were generally balanced between the 2 arms, except a higher proportion of females (52% versus 37%) and older median age (40 years versus 36 years) were noted in the omidubicel-onlv arm. Compared with patients receiving UCB transplantation, patients receiving omidubicel-onlv had a shorter average total hospital length of stay (mean, 41.2 days versus 50.8 days; P = .027) in the first 100 days post-transplantation and more days alive and out of the hospital (mean, 55.8 days versus 43.7 days; P = .023). Fewer patients died in the omidubicel-onlv arm compared with the UCB arm (12% vs 16%) before day 100 post-transplantation. During primary hospitalization (ie, time from transplantation to discharge), fewer patients receiving omidubicel-onlv required intensive care unit (ICU) admission (10% versus 23%) and spent fewer days in the ICU (mean, .4 day versus 4.7 days; P = .028) and transplant unit (mean, 25.3 days versus 32.9 days; P = .022) compared with those receiving UCB. Patients receiving omidubicel-onlv required fewer outpatient consultant and nonconsultant visits and fewer platelet or other transfusions within 100 days from transplantation. Our findings suggest that faster hematopoietic recovery in omidubicel-onlv patients is associated with significantly shorter hospital stay and reduced healthcare resource use compared with UCB.