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Phase I dose escalation study of naive T-cell depleted donor lymphocyte infusion following allogeneic stem cell transplantation.

Publication ,  Journal Article
Maung, KK; Chen, BJ; Barak, I; Li, Z; Rizzieri, DA; Gasparetto, C; Sullivan, KM; Long, GD; Engemann, AM; Waters-Pick, B; Nichols, KR; Lopez, R ...
Published in: Bone Marrow Transplant
January 2021

Prophylactic donor lymphocyte infusions (DLI) are used to augment post-transplant immune recovery to reduce both infectious complications and disease recurrence. Preclinical studies implicate the naive T-cell subset as the primary driver of graft-versus-host disease (GvHD). In this phase I dose escalation study, we assessed the safety of a DLI that was depleted of CD45RA+ naive T cells. Sixteen adult patients received a prophylactic DLI at a median of 113 days (range 76-280 days) following an HLA-identical, non-myeloablative allogeneic hematopoietic stem cell transplantation. Three patients each received the naive T-cell depleted DLI with a CD3+ dose of 1 × 105/kg, 1 × 106/kg, and 5 × 106/kg. The maximum dose of 1 × 107/kg was expanded to 7 patients. No dose-limiting grade III/IV acute GvHD or adverse events attributable to the DLI were observed at any dose level. One patient developed grade 2 acute GvHD of skin and upper intestines, and another developed moderate chronic GvHD of the lungs following the DLI. With a median follow-up of 2.8 years, 2-year progression-free and overall survival is 50.0% and 68.8%, respectively. In conclusion, these data suggest that a DLI that has been depleted of CD45RA+ naive T cells is feasible and carries a low risk of acute or chronic GvHD.

Duke Scholars

Published In

Bone Marrow Transplant

DOI

EISSN

1476-5365

Publication Date

January 2021

Volume

56

Issue

1

Start / End Page

137 / 143

Location

England

Related Subject Headings

  • T-Lymphocytes
  • Neoplasm Recurrence, Local
  • Lymphocyte Transfusion
  • Immunology
  • Humans
  • Hematopoietic Stem Cell Transplantation
  • Graft vs Host Disease
  • Adult
  • 3211 Oncology and carcinogenesis
  • 3201 Cardiovascular medicine and haematology
 

Citation

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Maung, K. K., Chen, B. J., Barak, I., Li, Z., Rizzieri, D. A., Gasparetto, C., … Horwitz, M. E. (2021). Phase I dose escalation study of naive T-cell depleted donor lymphocyte infusion following allogeneic stem cell transplantation. Bone Marrow Transplant, 56(1), 137–143. https://doi.org/10.1038/s41409-020-0991-5
Maung, Ko K., Benny J. Chen, Ian Barak, Zhiguo Li, David A. Rizzieri, Cristina Gasparetto, Keith M. Sullivan, et al. “Phase I dose escalation study of naive T-cell depleted donor lymphocyte infusion following allogeneic stem cell transplantation.Bone Marrow Transplant 56, no. 1 (January 2021): 137–43. https://doi.org/10.1038/s41409-020-0991-5.
Maung KK, Chen BJ, Barak I, Li Z, Rizzieri DA, Gasparetto C, et al. Phase I dose escalation study of naive T-cell depleted donor lymphocyte infusion following allogeneic stem cell transplantation. Bone Marrow Transplant. 2021 Jan;56(1):137–43.
Maung, Ko K., et al. “Phase I dose escalation study of naive T-cell depleted donor lymphocyte infusion following allogeneic stem cell transplantation.Bone Marrow Transplant, vol. 56, no. 1, Jan. 2021, pp. 137–43. Pubmed, doi:10.1038/s41409-020-0991-5.
Maung KK, Chen BJ, Barak I, Li Z, Rizzieri DA, Gasparetto C, Sullivan KM, Long GD, Engemann AM, Waters-Pick B, Nichols KR, Lopez R, Kang Y, Sarantopoulos S, Sung AD, Chao NJ, Horwitz ME. Phase I dose escalation study of naive T-cell depleted donor lymphocyte infusion following allogeneic stem cell transplantation. Bone Marrow Transplant. 2021 Jan;56(1):137–143.

Published In

Bone Marrow Transplant

DOI

EISSN

1476-5365

Publication Date

January 2021

Volume

56

Issue

1

Start / End Page

137 / 143

Location

England

Related Subject Headings

  • T-Lymphocytes
  • Neoplasm Recurrence, Local
  • Lymphocyte Transfusion
  • Immunology
  • Humans
  • Hematopoietic Stem Cell Transplantation
  • Graft vs Host Disease
  • Adult
  • 3211 Oncology and carcinogenesis
  • 3201 Cardiovascular medicine and haematology