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Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials.

Authors :
Lin C
Schwarzbach A
Sanz J
Montesinos P
Stiff P
Parikh S
Brunstein C
Cutler C
Lindemans CA
Hanna R
Koh LP
Jagasia MH
Valcarcel D
Maziarz RT
Keating AK
Hwang WYK
Rezvani AR
Karras NA
Fernandes JF
Rocha V
Badell I
Ram R
Schiller GJ
Volodin L
Walters MC
Hamerschlak N
Cilloni D
Frankfurt O
McGuirk JP
Kurtzberg J
Sanz G
Simantov R
Horwitz ME
Source :
Transplantation and cellular therapy [Transplant Cell Ther] 2023 May; Vol. 29 (5), pp. 338.e1-338.e6. Date of Electronic Publication: 2023 Feb 10.
Publication Year :
2023

Abstract

Omidubicel is an umbilical cord blood (UCB)-derived ex vivo-expanded cellular therapy product that has demonstrated faster engraftment and fewer infections compared with unmanipulated UCB in allogeneic hematopoietic cell transplantation. Although the early benefits of omidubicel have been established, long-term outcomes remain unknown. We report on a planned pooled analysis of 5 multicenter clinical trials including 105 patients with hematologic malignancies or sickle cell hemoglobinopathy who underwent omidubicel transplantation at 26 academic transplantation centers worldwide. With a median follow-up of 22 months (range, .3 to 122 months), the 3-year estimated overall survival and disease-free survival were 62.5% and 54.0%, respectively. With up to 10 years of follow-up, omidubicel showed durable trilineage hematopoiesis. Serial quantitative assessments of CD3 <superscript>+</superscript> , CD4 <superscript>+</superscript> , CD8 <superscript>+</superscript> , CD19 <superscript>+</superscript> , CD116 <superscript>+</superscript> CD56 <superscript>+</superscript> , and CD123 <superscript>+</superscript> immune subsets revealed median counts remaining within normal ranges through up to 8 years of follow-up. Secondary graft failure occurred in 5 patients (5%) in the first year, with no late cases reported. One case of donor-derived myeloid neoplasm was reported at 40 months post-transplantation. This was also observed in a control arm patient who received only unmanipulated UCB. Overall, omidubicel demonstrated stable trilineage hematopoiesis, immune competence, and graft durability in extended follow-up.<br /> (Copyright © 2023 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.)

Details

Language :
English
ISSN :
2666-6367
Volume :
29
Issue :
5
Database :
MEDLINE
Journal :
Transplantation and cellular therapy
Publication Type :
Academic Journal
Accession number :
36775201
Full Text :
https://doi.org/10.1016/j.jtct.2023.01.031