CT-039 Health-Related Quality of Life Following Allogeneic Hematopoietic Stem Cell Transplantation With Omidubicel Versus Standard Umbilical Cord Blood.

Journal Article (Journal Article;Multicenter Study)

CONTEXT: Omidubicel is an ex vivo expanded stem cell product derived from umbilical cord blood (UCB) for allogeneic hematopoietic stem cell transplantation (allo-HSCT). A multicenter phase III trial demonstrated faster engraftment and fewer infections with omidubicel versus standard UCB. OBJECTIVE: To compare patient-reported health-related quality of life (HRQL) between omidubicel and UCB. DESIGN: Patients with hematologic malignancies undergoing allo-HSCT were randomized 1:1 to omidubicel or UCB between 2017-2020. Validated HRQL surveys (FACT-BMT and EQ-5D-3L) were administered on screening and days 42, 100, 180, and 365 post-transplant. SETTING: Twenty-eight international academic centers. PATIENTS: Among 108 patients undergoing allo-HSCT, 75 (69%) who completed HRQL surveys at screening and on at least one follow-up visit were included. Baseline characteristics were similar between arms, with a mean age of 36, 59% male, 41% non-white, and 77% intermediate/high disease risk. Most common diagnoses were AML (45%) and ALL (35%). INTERVENTIONS: Myeloablative allo-HSCT with omidubicel or UCB followed by standard GVHD prophylaxis with a calcineurin inhibitor and mycophenolate mofetil. OUTCOMES: This is a secondary exploratory analysis evaluating changes in FACT-BMT and EQ-5D-3L post-transplant, measuring physical, functional, emotional, family/social, and overall well-being. HRQL scores over the first 365 days were compared using the area under the curve (AUC) of mean HRQL trajectories in each arm. RESULTS: Baseline HRQL scores were similar between the two arms. Initial HRQL declines at day 42 were numerically better with omidubicel. Over the first year, AUC of physical well-being scores was better with omidubicel (p = 0.02, mean difference 1.5-3.1), exceeding the minimal clinically important difference (MCID) of 2 points on days 180 and 365. Similarly, AUCs of HSCT-specific and functional well-being scores favored omidubicel (p = 0.04). AUCs of total FACT-BMT scores were better with omidubicel (p = 0.01, mean difference 7.2-11), exceeding the MCID of 7 points at all time points. There were numerical but non-significant improvements in AUCs of FACT-BMT social/family, emotional, and EQ-5D-3L general well-being scores with omidubicel. CONCLUSIONS: Omidubicel showed clinically meaningful and sustained improvements in physical, functional, and overall well-being compared to UCB transplantation.

Full Text

Duke Authors

Cited Authors

  • Lin, C; Sajeev, G; Stiff, P; Brunstein, C; Cutler, C; Sanz, G; Lindemans, C; Rezvani, A; Hanna, R; Koh, LP; Maziarz, R; Hwang, W; Song, Y; Liu, Q; Manghani, R; Sivaraman, S; Signorovitch, J; Galamidi-Cohen, E; Horwitz, M; Sung, A

Published Date

  • October 2022

Published In

Volume / Issue

  • 22 Suppl 2 /

Start / End Page

  • S432 - S433

PubMed ID

  • 36164194

Electronic International Standard Serial Number (EISSN)

  • 2152-2669

Digital Object Identifier (DOI)

  • 10.1016/S2152-2650(22)01643-3


  • eng

Conference Location

  • United States