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

Publication ,  Conference
Lin, C; Schwarzbach, A; Sanz, J; Montesinos, P; Stiff, P; Parikh, S; Brunstein, C; Cutler, C; Lindemans, CA; Hanna, R; Koh, LP; Jagasia, MH ...
Published in: Transplant Cell Ther
May 2023

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+, CD4+, CD8+, CD19+, CD116+CD56+, and CD123+ 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.

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Published In

Transplant Cell Ther

DOI

EISSN

2666-6367

Publication Date

May 2023

Volume

29

Issue

5

Start / End Page

338.e1 / 338.e6

Location

United States

Related Subject Headings

  • Prospective Studies
  • Multicenter Studies as Topic
  • Humans
  • Hematopoietic Stem Cell Transplantation
  • Follow-Up Studies
  • Disease-Free Survival
  • 3211 Oncology and carcinogenesis
  • 3201 Cardiovascular medicine and haematology
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

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Lin, C., Schwarzbach, A., Sanz, J., Montesinos, P., Stiff, P., Parikh, S., … Horwitz, M. E. (2023). Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials. In Transplant Cell Ther (Vol. 29, pp. 338.e1-338.e6). United States. https://doi.org/10.1016/j.jtct.2023.01.031
Lin, Chenyu, Aurelie Schwarzbach, Jaime Sanz, Pau Montesinos, Patrick Stiff, Suhag Parikh, Claudio Brunstein, et al. “Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials.” In Transplant Cell Ther, 29:338.e1-338.e6, 2023. https://doi.org/10.1016/j.jtct.2023.01.031.
Lin C, Schwarzbach A, Sanz J, Montesinos P, Stiff P, Parikh S, et al. Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials. In: Transplant Cell Ther. 2023. p. 338.e1-338.e6.
Lin, Chenyu, et al. “Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials.Transplant Cell Ther, vol. 29, no. 5, 2023, pp. 338.e1-338.e6. Pubmed, doi:10.1016/j.jtct.2023.01.031.
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. Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials. Transplant Cell Ther. 2023. p. 338.e1-338.e6.

Published In

Transplant Cell Ther

DOI

EISSN

2666-6367

Publication Date

May 2023

Volume

29

Issue

5

Start / End Page

338.e1 / 338.e6

Location

United States

Related Subject Headings

  • Prospective Studies
  • Multicenter Studies as Topic
  • Humans
  • Hematopoietic Stem Cell Transplantation
  • Follow-Up Studies
  • Disease-Free Survival
  • 3211 Oncology and carcinogenesis
  • 3201 Cardiovascular medicine and haematology
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences