Abstract

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.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Division of Blood Diseases And Resources (NHLBI)
Type
Research and Development Contracts (N01)
Project #
N01HB047097-009
Application #
2651058
Study Section
Project Start
1993-11-01
Project End
2001-04-30
Budget Start
1997-09-08
Budget End
1997-10-31
Support Year
Fiscal Year
1997
Total Cost
Indirect Cost

  Institution

Name
University of Kentucky
Department
Administration
Type
Schools of Education
DUNS #
832127323
City
Lexington
State
KY
Country
United States
Zip Code
40506

  Publications

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
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
Humphreys, C T; Tallman, B; Altmaier, E M et al. (2007) Sexual functioning in patients undergoing bone marrow transplantation: a longitudinal study. Bone Marrow Transplant 39:491-6
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
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
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