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A randomized phase II study to evaluate tacrolimus in combination with sirolimus or methotrexate after allogeneic hematopoietic cell transplantation

2012; Ferrata Storti Foundation; Volume: 97; Issue: 12 Linguagem: Inglês

10.3324/haematol.2012.067140

1592-8721

Joseph Pidala, J. Kim, Heather Jim, Mohamed A. Kharfan‐Dabaja, Taiga Nishihori, Hugo F. Fernández, Marcie Tomblyn, Lia Perez, Janelle Perkins, Min Xu, William E. Janssen, Anandharaman Veerapathran, Brian C. Betts, Frederick L. Locke, Ernesto Ayala, Teresa Field, L. Ochoa, Melissa Alsina, Claudio Anasetti,

Immune Cell Function and Interaction

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