T-Cell Depletion in Unrelated Donor Marrow Transplantation

This study has been completed.

First Received: October 27, 1999 Last Updated: November 10, 2005 History of Changes

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000591

Purpose

To determine if a reduction in morbidity and mortality from acute and chronic graft versus host disease (GvHD) can be achieved through use of T-cell depletion techniques without a counterbalancing increase in relapse of leukemia in patients receiving an unrelated donor marrow transplant.

Condition	Intervention	Phase
Bone Marrow Transplantation Graft Vs Host Disease Immunologic Diseases Leukemia Myelodysplastic Syndromes	Procedure: lymphocyte depletion	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:	November 1993
Estimated Study Completion Date:	February 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	1 Year to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

No eligibility criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000591

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigator:	Shelly Carter	The EMMES Corporation
Investigator:	John Wagner	University of Minnesota

More Information

Publications:

Howe C, Wagner J, Kerman N, et al. 1995. T-cell Depletion in Unrelated-donor Marrow Transplantation. Blood 391a (abstract).

Grewal SS, Barker JN, Davies SM, Wagner JE. Unrelated donor hematopoietic cell transplantation: marrow or umbilical cord blood? Blood. 2003 Jan 9 [epub ahead of print]

Davies SM, Radloff GA, Wagner JE, McGlennen R, Kersey JH, Ramsay NK. Polyclonal engraftment after unrelated donor bone marrow and cord blood transplantation. Biol Blood Marrow Transplant. 1997 Dec;3(6):304-9.

Davies SM, Wagner JE, Defor T, Blazar BR, Katsanis E, Kersey JH, Orchard PJ, McGlave PB, Weisdorf DJ, Ramsay NK. Unrelated donor bone marrow transplantation for children and adolescents with aplastic anaemia or myelodysplasia. Br J Haematol. 1997 Mar;96(4):749-56.

Davies SM, Wagner JE, Weisdorf DJ, Shu XO, Blazar BR, Enright H, McGlave PB, Ramsay NK. Unrelated donor bone marrow transplantation for hematological malignancies-current status. Leuk Lymphoma. 1996 Oct;23(3-4):221-6. Review.

Pawlowska AB, Davies SM, Orchard PJ, Wagner JE, Ramsay NK. Unrelated donor bone marrow transplantation for acute leukemia in patients with Down's syndrome. Bone Marrow Transplant. 1996 Aug;18(2):453-5.

Davies SM, Szabo E, Wagner JE, Ramsay NK, Weisdorf DJ. Idiopathic hyperammonemia: a frequently lethal complication of bone marrow transplantation. Bone Marrow Transplant. 1996 Jun;17(6):1119-25.

Davies SM, Khan S, Wagner JE, Arthur DC, Auerbach AD, Ramsay NK, Weisdorf DJ. Unrelated donor bone marrow transplantation for Fanconi anemia. Bone Marrow Transplant. 1996 Jan;17(1):43-7.

Pavletic SZ, Carter SL, Kernan NA, Henslee-Downey J, Mendizabal AM, Papadopoulos E, Gingrich R, Casper J, Yanovich S, Weisdorf D. Influence of T cell depletion on chronic Graft-Versus-Host Disease: results of a multi-center randomized trial in unrelated marrow donor transplantation. Blood. 2005 Jul 26; [Epub ahead of print]

de Lissovoy G, Hurd D, Carter S, Beatty P, Ewell M, Henslee-Downey J, Kernan N, Yanovich S, Weisdorf D. 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. 2005 Jul 25; [Epub ahead of print]

McCullough J, McKenna D, Kadidlo D, Schierman T, Wagner J. Issues in the quality of umbilical cord blood stem cells for transplantation. Transfusion. 2005 Jun;45(6):832-41.

Wagner JE, Thompson JS, Carter SL, Kernan NA; Unrelated Donor Marrow Transplantation Trial. 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. 2005 Aug 27-Sep 2;366(9487):733-41.

Study ID Numbers:	311
Study First Received:	October 27, 1999
Last Updated:	November 10, 2005
ClinicalTrials.gov Identifier:	NCT00000591 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Disease
Immune System Diseases
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Leukemia

Preleukemia
Neoplasms
Pathologic Processes
Syndrome
Graft vs Host Disease
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 22, 2009