This contract is part of a clinical trial of T cell-depletion in unrelated donor bone marrow transplantation. The primary objective of the clinical trial is to determine if a reduction in morbidity and mortality from acute and chronic graft versus host disease (GvHD) can be achieved in patients given T cell-depleted marrow from an unrelated donor without a counterbalancing increase in relapse of leukemia and graft failure. This prospective clinical trial will require a total of 560 patients, randomized to T cell- depletion or no depletion of their graft. Two important components of this study are to characterize the numbers and types of cells in the graft, and to monitor immune reconstitution. This project includes a medical coordinating center and four therapy groups. The medical coordinating center is staffed by biostatisticians, an immunologist, computer programmers, and research coordinators. The medical coordinating center will make randomized treatment assignments, collect and monitor the data, analyze the results, and produce summary reports. The study is expected to last seven and one-half years.

National Institute of Health (NIH)
Division of Blood Diseases And Resources (NHLBI)
Research and Development Contracts (N01)
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Emmes Corporation
United States
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Keever-Taylor, C A; Wagner, J E; Kernan, N A et al. (2010) Comparison of immune recovery in recipients of unmanipulated vs T-cell-depleted grafts from unrelated donors in a multicenter randomized phase II-III trial (T-cell depletion trial). Bone Marrow Transplant 45:587-9
van Burik, Jo-Anne H; Carter, Shelly L; Freifeld, Alison G et al. (2007) Higher risk of cytomegalovirus and aspergillus infections in recipients of T cell-depleted unrelated bone marrow: analysis of infectious complications in patients treated with T cell depletion versus immunosuppressive therapy to prevent graft-versus-host Biol Blood Marrow Transplant 13:1487-98
Hochhausen, Nicole; Altmaier, Elizabeth M; McQuellon, Richard et al. (2007) Social support, optimism, and self-efficacy predict physical and emotional well-being after bone marrow transplantation. J Psychosoc Oncol 25:87-101
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Wagner, John E; Thompson, John S; Carter, Shelly L et al. (2005) Effect of graft-versus-host disease prophylaxis on 3-year disease-free survival in recipients of unrelated donor bone marrow (T-cell Depletion Trial): a multi-centre, randomised phase II-III trial. Lancet 366:733-41
de Lissovoy, G; Hurd, D; Carter, S et al. (2005) Economic analysis of unrelated allogeneic bone marrow transplantation: results from the randomized clinical trial of T-cell depletion vs unmanipulated grafts for the prevention of graft-versus-host disease. Bone Marrow Transplant 36:539-46
Pavletic, Steven Z; Carter, Shelly L; Kernan, Nancy A et al. (2005) Influence of T-cell depletion on chronic graft-versus-host disease: results of a multicenter randomized trial in unrelated marrow donor transplantation. Blood 106:3308-13