Patients transplanted with omidubicel showed “clinically meaningful and sustained improvements in physical, functional, and overall well-being” compared with patients transplanted with umbilical cord blood, according to recent research presented at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO).
Omidubicel, an ex vivo expanded stem-cell product derived from umbilical cord blood, can be used for allogeneic hematopoietic stem-cell transplantation (HSCT). A phase III clinical trial showed more rapid engraftment and fewer infections occurred in patients receiving a transplant with omidubicel than in patients receiving a transplant with umbilical cord blood, according to the researchers.
Chenyu Lin, MD, of Duke University Medical Center in Durham, North Carolina, and colleagues conducted the study at 28 international academic centers and included 108 patients with hematologic malignancies who underwent HSCT between 2017 and 2020. The researchers randomized patients in a 1:1 ratio to undergo transplant with omidubicel or umbilical cord blood.
Patients filled out health-related quality-of-life surveys (FACT-BMT and EQ-5D-3L) during screening and on posttransplant days 42, 100, 180, and 365. Researchers analyzed data from the 75 patients (69%) who completed the surveys during screening and during at least 1 follow-up visit.
The mean patient age was 36 years, 59% of patients were male, and 41% of patients were non-White. Acute myeloid leukemia (45%) and acute lymphoblastic leukemia (35%) were the most common diagnoses. Most patients (77%) had intermediate or high disease risk. All patients underwent myeloablative allogeneic HSCT with omidubicel or umbilical cord blood. Patients received posttransplant graft-versus-host disease prophylaxis with a calcineurin inhibitor and mycophenolate mofetil.
The baseline health-related quality-of-life survey scores were comparable between patients receiving umbilical cord blood and patients receiving omidubicel. However, initial health-related quality of life at day 42 was “numerically better with omidubicel,” Dr. Lin and colleagues reported. Over the first year, the physical well-being scores were significantly better in patients who received omidubicel than in patients who received umbilical cord blood (P=.02).
The physical well-being scores of patients receiving omidubicel exceeded the minimal clinically important difference of 2 points on days 180 and 365, the researchers reported. The HSCT-specific and functional well-being scores were also significantly better in patients receiving omidubicel (P=.04) as were the total well-being scores (P=.01), which exceeded the minimal clinically important difference of 7 points at all time points.
“Omidubicel showed clinically meaningful and sustained improvements in physical, functional, and overall well-being compared to [umbilical cord blood] transplantation,” Dr. Lin and colleagues concluded.
Lin C, Sajeev G, Stiff P, et al. Health-related quality of life following allogeneic hematopoietic stem cell transplantation with omidubicel versus standard umbilical cord blood. Poster CT-039. Presented at the Tenth Annual Meeting of the Society of Hematologic Oncology; September 28-October 1, 2022; Houston, TX.
