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Prophylaxis of graft-versus-host disease in unrelated donor transplantation with pentostatin, tacrolimus, and mini-methotrexate: a phase I/II controlled, adaptively randomized study.
Simrit Parmar
1 ,
Borje S Andersson ,
Daniel Couriel ,
Mark F Munsell ,
Marcelo Fernandez-Vina ,
Roy B Jones ,
Elizabeth J Shpall ,
Uday Popat ,
Paolo Anderlini ,
Sergio Giralt ,
Amin Alousi ,
Pedro Cano ,
Doyle Bosque ,
Chitra Hosing ,
Leandro de Padua Silva ,
Michael Westmoreland ,
J Kyle Wathen ,
Donald Berry ,
Richard E Champlin ,
Marcos J de Lima
Jan 20 2011
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Abstract
Acute graft-versus-host disease (aGVHD) is a major cause of morbidity and mortality after matched unrelated, related, or mismatched related donor hematopoietic stem-cell transplantation (HSCT). Improved GVHD prevention methods are needed. Pentostatin, an adenosine deaminase inhibitor, leads to lymphocyte depletion with low risk of myelosuppression. We hypothesized that addition of pentostatin to GVHD prophylaxis with tacrolimus and mini-methotrexate may improve outcomes, and we conducted a Bayesian adaptively randomized, controlled, dose-finding study, taking into account toxicity and efficacy.