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Bone Marrow Transplant. 2019 Oct 15. doi: 10.1038/s41409-019-0715-x. [Epub ahead of print]

A phase II study of reduced intensity double umbilical cord blood transplantation using fludarabine, melphalan, and low dose total body irradiation.

Author information

1
Blood and Marrow Transplant Program, Massachusetts General Hospital, Boston, MA, USA.
2
Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA.
3
Division of Hematology and Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
4
Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, MA, USA.
5
Division of Hematology/Oncology, University of Virginia School of Medicine, Charlottesville, VA, USA.
6
Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, MA, USA. cscutler@partners.org.

Abstract

In this multicenter Phase 2 single arm study, we substituted low dose total body irradiation (TBI) for antithymocyte globulin (ATG) in a reduced intensity conditioning regimen with the intent to lower the risk for viral infections after double umbilical cord blood (UCB) transplantation. The conditioning regimen consisted of fludarabine (30 mg/m2/day, Day -7 to -2), melphalan (100 mg/m2/day, Day -1), and TBI (200cGy, Day 0). Graft-versus-host disease prophylaxis was sirolimus and tacrolimus. Thirty-one patients were treated on the protocol. The median time of follow-up for survivors was 24 months (range, 3.3-55.1). Nineteen patients experienced a total of 24 clinically significant viral reactivations or infections, with 1-year cumulative incidence rate of first significant viral event as 64% (95% CI, 43-79%), compared with our historical control of 53%. Within the context of these 24 clinically significant viral reactivations, there were a total of 10 infections with organ involvement. Nonrelapse mortality was 28% (95% CI 13-45%) at 2 years. The 2-year overall and progression-free survivals were 53% (95% CI 33-69%) and 47% (95% CI 28-64%), respectively. In conclusion, the substitution of low dose TBI for ATG did not decrease the incidence of significant viral events after UCB transplantation.

PMID:
31616065
DOI:
10.1038/s41409-019-0715-x

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