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

Chenyu Lin, Gautam Sajeev, Patrick Stiff, Claudio Brunstein, Corey Cutler, Guillermo Sanz, Caroline Lindemans, Andrew Rezvani, Rabi Hanna, Liang Piu Koh, Richard Maziarz, William Hwang, Yan Song, Qing Liu, Rocio Manghani, Smitha Sivaraman, James Signorovitch, Einat Galamidi-Cohen, Mitchell Horwitz, Anthony Sung

Onderzoeksoutput: Bijdrage aan tijdschriftArtikelpeer review


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.

Originele taal-2Engels
Pagina's (van-tot)S432-S433
TijdschriftClinical Lymphoma, Myeloma and Leukemia
StatusGepubliceerd - okt. 2022
Extern gepubliceerdJa


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