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

doi:10.3324/haematol.2012.067140

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

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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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