Anti-Thymocyte Globulin (Thymoglobulin), Tacrolimus, and Sirolimus as Acute Graft-versus-Host Disease Prophylaxis for Unrelated Hematopoietic Stem Cell Transplantation

Zaid Al-Kadhimi, Zartash Gul, Roberto Rodriguez, Wei Chen, Daryn Smith, Alice Mitchell, Muneer Abidi, Lois Ayash, Abhinav Deol, Lawrence Lum, Stephen Forman, Voravit Ratanatharathorn, Joseph Uberti

Research output: Contribution to journalArticle

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Abstract

Acute graft-versus-host disease (aGVHD) is a major cause of morbidity and mortality in patients undergoing unrelated hematopoietic stem cell transplantation. We prospectively evaluated the efficacy of intermediate-dose rabbit anti-thymocyte globulin (Thymoglobulin® a total of 4.5 mg/kg given over days -3, -2, and -1) in combination with tacrolimus and sirolimus for the prevention of aGVHD. We enrolled 47 recipients who underwent unrelated hematopoietic stem cell transplantation. Patients received daily granulocyte colony-stimulating factor starting on day +6 until neutrophil engraftment (median duration, 11 days; range, 9-15 days). Twenty-two patients received HLA 8/8 and 25 received 7/8 matched grafts, respectively. The median follow-up duration was 23.6 months (range, 18.8-27.9 months). The cumulative incidence of grade II to IV aGVHD was 23.4% (95% confidence interval, 12.4-36.3). At 2-year follow-up, the cumulative incidence of nonrelapse mortality was 31.9%, cumulative incidence of relapse was 24.6%, and cumulative incidence of chronic GVHD was 33%. Progression-free survival at 1 year was 54%, with a median of 17.7 months. Overall survival at 1 year was 65%, with no median reached. These results suggest that the combination of Thymoglobulin, tacrolimus, and sirolimus in patients undergoing unrelated hematopoietic stem cell transplantation is well tolerated and associated with a low incidence and severity of aGVHD and chronic graft-versus-host disease.

Original languageEnglish (US)
Pages (from-to)1734-1744
Number of pages11
JournalBiology of Blood and Marrow Transplantation
Volume18
Issue number11
DOIs
StatePublished - Nov 1 2012

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Antilymphocyte Serum
Hematopoietic Stem Cell Transplantation
Tacrolimus
Graft vs Host Disease
Sirolimus
Incidence
Globulins
Thymocytes
Mortality
Granulocyte Colony-Stimulating Factor
Disease-Free Survival
Neutrophils
Confidence Intervals
Rabbits
Morbidity
Transplants
Recurrence
Survival

Keywords

  • AGVHD
  • Antithymocyte globulin
  • Sirolimus
  • Tacrolimus
  • Unrelated hematopoietic stem cell transplantation

ASJC Scopus subject areas

  • Hematology
  • Transplantation

Cite this

Anti-Thymocyte Globulin (Thymoglobulin), Tacrolimus, and Sirolimus as Acute Graft-versus-Host Disease Prophylaxis for Unrelated Hematopoietic Stem Cell Transplantation. / Al-Kadhimi, Zaid; Gul, Zartash; Rodriguez, Roberto; Chen, Wei; Smith, Daryn; Mitchell, Alice; Abidi, Muneer; Ayash, Lois; Deol, Abhinav; Lum, Lawrence; Forman, Stephen; Ratanatharathorn, Voravit; Uberti, Joseph.

In: Biology of Blood and Marrow Transplantation, Vol. 18, No. 11, 01.11.2012, p. 1734-1744.

Research output: Contribution to journalArticle

Al-Kadhimi, Z, Gul, Z, Rodriguez, R, Chen, W, Smith, D, Mitchell, A, Abidi, M, Ayash, L, Deol, A, Lum, L, Forman, S, Ratanatharathorn, V & Uberti, J 2012, 'Anti-Thymocyte Globulin (Thymoglobulin), Tacrolimus, and Sirolimus as Acute Graft-versus-Host Disease Prophylaxis for Unrelated Hematopoietic Stem Cell Transplantation', Biology of Blood and Marrow Transplantation, vol. 18, no. 11, pp. 1734-1744. https://doi.org/10.1016/j.bbmt.2012.06.004
Al-Kadhimi, Zaid ; Gul, Zartash ; Rodriguez, Roberto ; Chen, Wei ; Smith, Daryn ; Mitchell, Alice ; Abidi, Muneer ; Ayash, Lois ; Deol, Abhinav ; Lum, Lawrence ; Forman, Stephen ; Ratanatharathorn, Voravit ; Uberti, Joseph. / Anti-Thymocyte Globulin (Thymoglobulin), Tacrolimus, and Sirolimus as Acute Graft-versus-Host Disease Prophylaxis for Unrelated Hematopoietic Stem Cell Transplantation. In: Biology of Blood and Marrow Transplantation. 2012 ; Vol. 18, No. 11. pp. 1734-1744.
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abstract = "Acute graft-versus-host disease (aGVHD) is a major cause of morbidity and mortality in patients undergoing unrelated hematopoietic stem cell transplantation. We prospectively evaluated the efficacy of intermediate-dose rabbit anti-thymocyte globulin (Thymoglobulin{\circledR} a total of 4.5 mg/kg given over days -3, -2, and -1) in combination with tacrolimus and sirolimus for the prevention of aGVHD. We enrolled 47 recipients who underwent unrelated hematopoietic stem cell transplantation. Patients received daily granulocyte colony-stimulating factor starting on day +6 until neutrophil engraftment (median duration, 11 days; range, 9-15 days). Twenty-two patients received HLA 8/8 and 25 received 7/8 matched grafts, respectively. The median follow-up duration was 23.6 months (range, 18.8-27.9 months). The cumulative incidence of grade II to IV aGVHD was 23.4{\%} (95{\%} confidence interval, 12.4-36.3). At 2-year follow-up, the cumulative incidence of nonrelapse mortality was 31.9{\%}, cumulative incidence of relapse was 24.6{\%}, and cumulative incidence of chronic GVHD was 33{\%}. Progression-free survival at 1 year was 54{\%}, with a median of 17.7 months. Overall survival at 1 year was 65{\%}, with no median reached. These results suggest that the combination of Thymoglobulin, tacrolimus, and sirolimus in patients undergoing unrelated hematopoietic stem cell transplantation is well tolerated and associated with a low incidence and severity of aGVHD and chronic graft-versus-host disease.",
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AU - Gul, Zartash

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AU - Smith, Daryn

AU - Mitchell, Alice

AU - Abidi, Muneer

AU - Ayash, Lois

AU - Deol, Abhinav

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AU - Forman, Stephen

AU - Ratanatharathorn, Voravit

AU - Uberti, Joseph

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