T-Cell Depletion in Unrelated Donor Marrow Transplantation

NCT00000591 | Completed Phase 3

• 1 other identifier: 311
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bone Marrow Transplantation; Graft vs Host Disease; Immunologic Diseases; Leukemia; Myelodysplastic Syndromes

Interventions

lymphocyte depletion PROCEDURE

Eligibility Criteria

• Age: 1 Year - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (12)

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

  BACKGROUND

• Grewal SS, Barker JN, Davies SM, Wagner JE. Unrelated donor hematopoietic cell transplantation: marrow or umbilical cord blood? Blood. 2003 Jun 1;101(11):4233-44. doi: 10.1182/blood-2002-08-2510. Epub 2003 Jan 9. No abstract available.

  PMID: 12522002 BACKGROUND

• 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.

  PMID: 9502297 BACKGROUND

• 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. doi: 10.1046/j.1365-2141.1997.d01-2087.x.

  PMID: 9074418 BACKGROUND

• 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. doi: 10.3109/10428199609054824.

  PMID: 9031102 BACKGROUND

• 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.

  PMID: 8864463 BACKGROUND

• 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.

  PMID: 8807124 BACKGROUND

• 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.

  PMID: 8673053 BACKGROUND

• Pavletic SZ, Carter SL, Kernan NA, Henslee-Downey J, Mendizabal AM, Papadopoulos E, Gingrich R, Casper J, Yanovich S, Weisdorf D; National Heart, Lung, and Blood Institute Unrelated Donor Marrow Transplantation Trial. Influence of T-cell depletion on chronic graft-versus-host disease: results of a multicenter randomized trial in unrelated marrow donor transplantation. Blood. 2005 Nov 1;106(9):3308-13. doi: 10.1182/blood-2005-04-1614. Epub 2005 Jul 26.

  PMID: 16046530 BACKGROUND

• 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 Sep;36(6):539-46. doi: 10.1038/sj.bmt.1705078.

  PMID: 16044144 BACKGROUND

• 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. doi: 10.1111/j.1537-2995.2005.04265.x.

  PMID: 15934980 BACKGROUND

• 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. doi: 10.1016/S0140-6736(05)66996-6.

  PMID: 16125590 BACKGROUND

MeSH Terms

Conditions

Graft vs Host Disease; Immune System Diseases; Leukemia; Myelodysplastic Syndromes

Interventions

Lymphocyte Depletion

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Shelly Carter

  The Emmes Company, LLC

• John Wagner

  University of Minnesota

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: November 1, 1993
• Study Completion: February 1, 2005
• Last Updated: April 15, 2016

Record last verified: 2005-11