Haematologica
(Dec 2012)
A randomized phase II study to evaluate tacrolimus in combination with sirolimus or methotrexate after allogeneic hematopoietic cell transplantation
Joseph Pidala,
Jongphil Kim,
Heather Jim,
Mohamed A. Kharfan-Dabaja,
Taiga Nishihori,
Hugo F. Fernandez,
Marcie Tomblyn,
Lia Perez,
Janelle Perkins,
Mian Xu,
William E. Janssen,
Anandaraman Veerapathran,
Brian C. Betts,
Frederick L. Locke,
Ernesto Ayala,
Teresa Field,
Leonel Ochoa,
Melissa Alsina,
Claudio Anasetti
Affiliations
Joseph Pidala
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
Jongphil Kim
Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL;Biostatistics, Moffitt Cancer Center, Tampa, FL
Heather Jim
Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL;Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA
Mohamed A. Kharfan-Dabaja
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
Taiga Nishihori
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
Hugo F. Fernandez
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
Marcie Tomblyn
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
Lia Perez
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
Janelle Perkins
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
Mian Xu
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL
William E. Janssen
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
Anandaraman Veerapathran
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL
Brian C. Betts
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
Frederick L. Locke
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
Ernesto Ayala
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
Teresa Field
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
Leonel Ochoa
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
Melissa Alsina
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
Claudio Anasetti
Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL;Oncologic Sciences, College of Medicine at University of South Florida, Tampa, FL
DOI
https://doi.org/10.3324/haematol.2012.067140
Journal volume & issue
Vol. 97,
no. 12
Abstract
Read online
Background There is evidence suggesting that sirolimus, in combination with tacrolimus, is active in the prevention of graft-versus-host disease. Sirolimus-based immune suppression may suppress alloreactive T cells, while sparing the survival and function of regulatory T cells.Design and Methods We conducted a randomized trial to compare the impact of sirolimus/tacrolimus against that of methotrexate/tacrolimus on the prevention of graft-versus-host disease and regulatory T-cell reconstitution.Results Seventy-four patients were randomized 1:1 to sirolimus/tacrolimus or methotrexate/tacrolimus, stratified for type of donor (sibling or unrelated) and the patients' age. The rate of grade II-IV acute graft-versus-host disease at 100 days was 43% (95% CI: 27-59%) in the sirolimus/tacrolimus group and 89% (95% CI: 72-96%) in the methotrexate/tacrolimus group (P
Published in Haematologica
ISSN
0390-6078 (Print)
1592-8721 (Online)
Publisher
Ferrata Storti Foundation
Country of publisher
Italy
LCC subjects
Medicine: Internal medicine: Specialties of internal medicine: Diseases of the blood and blood-forming organs
Website
http://www.haematologica.org
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