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 #
N01HB047095-009
Application #
2660243
Study Section
Project Start
1993-11-01
Project End
2001-04-30
Budget Start
1997-09-24
Budget End
1998-10-31
Support Year
Fiscal Year
1997
Total Cost
Indirect Cost

  Institution

Name
University of Minnesota Twin Cities
Department
Type
Organized Research Units
DUNS #
168559177
City
Minneapolis
State
MN
Country
United States
Zip Code
55455

  Publications

Koepsell, Scott A; Kadidlo, Diane M; Fautsch, Susan et al. (2013) Successful ""in-flight"" activation of natural killer cells during long-distance shipping. Transfusion 53:398-403
Flynn, Catherine M; Hirsch, Betsy; Defor, Todd et al. (2007) Reduced intensity compared with high dose conditioning for allotransplantation in acute myeloid leukemia and myelodysplastic syndrome: a comparative clinical analysis. Am J Hematol 82:867-72
McKenna Jr, David H; Sumstad, Darin; Bostrom, Nancy et al. (2007) Good manufacturing practices production of natural killer cells for immunotherapy: a six-year single-institution experience. Transfusion 47:520-8
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
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
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
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
Barker, Juliet N; Hough, Rachael E; van Burik, Jo-Anne H et al. (2005) Serious infections after unrelated donor transplantation in 136 children: impact of stem cell source. Biol Blood Marrow Transplant 11:362-70
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

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