This contract is part of a study of T cell-depletion in unrelated donor bone marrow transplantation. The primary objective 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, randomized study will require a total of 560 patients. Study investigators will randomize patients to T cell-depletion or no-depletion. Each therapy group will utilize their own method of T cell-depletion. Two important components of this study are to characterize the transplanted marrow with regard to numbers and types of cells in the graft, and to monitor immune reconstitution. This project includes 4 therapy groups and a medical coordinating center. This study is expected to last seven and one-half years.

Agency
National Institute of Health (NIH)
Institute
Division of Blood Diseases And Resources (NHLBI)
Type
Research and Development Contracts (N01)
Project #
N01HB047095-013
Application #
6074397
Study Section
Project Start
1993-11-01
Project End
2001-04-30
Budget Start
1999-04-27
Budget End
1999-10-31
Support Year
Fiscal Year
1999
Total Cost
Indirect Cost
Name
University of Minnesota Twin Cities
Department
Type
Organized Research Units
DUNS #
168559177
City
Minneapolis
State
MN
Country
United States
Zip Code
55455
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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
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Altmaier, Elizabeth M; Ewell, Marian; McQuellon, Richard et al. (2006) The effect of unrelated donor marrow transplantation on health-related quality of life: a report of the unrelated donor marrow transplantation trial (T-cell depletion trial). Biol Blood Marrow Transplant 12:648-55
McCullough, Jeffrey; McKenna, David; Kadidlo, Diane et al. (2005) Issues in the quality of umbilical cord blood stem cells for transplantation. Transfusion 45:832-41
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

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