Cell Selection for Bone Marrow Transplants to Prevent Graft-Versus-Host-Disease - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001872

Purpose

Blood contains different kinds of cells, white blood cells, red blood cells, and platelets. In order to treat certain diseases, specific cell types can be removed from blood and transplanted into patients. The process of removing white blood cells for the treatment of leukemia is called apheresis.

This study will make available blood cell collections from volunteers genetically matched to various degrees with recipients in order to test and, if necessary, refine the process of removing white blood cell T-lymphocytes.

Condition
Graft vs Host Disease Hematologic Neoplasm

Study Type:	Observational
Study Design:	Prospective
Official Title:	Apheresis of Family Members of Patients Undergoing Allogeneic Bone Marrow Transplantation. A Pre-Clinical Study of Selective Depletion of Donor Lymphocytes to Prevent Acute Graft-Versus-Host Disease

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Cancer

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	40
Study Start Date:	February 1999
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Detailed Description:

This protocol has been written to make available apheresis collections from volunteers matched to various degrees with recipients in order to test and, if necessary refine, the selective immunodepletion procedure prior to introducing it in a clinical trial.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

INCLUSION CRITERIA:

Family members of patients admitted to NHLBI allogeneic BMT protocols.

Ages 18 and older and less than age 65.

Parent of patient (obligate haplotype match) OR HLA 3/6, 4/6, 5/6, or 6/6 match with patient.

Research apheresis available from patient.

EXCLUSION CRITERIA:

Pregnancy or lactation.

HLA type unknown.

More than one haplotype mismatch with patient.

History of any immunosuppressive disease

History of chronic viral antigenic stimulus

Venous access inadequate.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001872

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Datta AR, Barrett AJ, Jiang YZ, Guimaraes A, Mavroudis DA, van Rhee F, Gordon AA, Madrigal A. Distinct T cell populations distinguish chronic myeloid leukaemia cells from lymphocytes in the same individual: a model for separating GVHD from GVL reactions. Bone Marrow Transplant. 1994 Oct;14(4):517-24.

Mavroudis DA, Jiang YZ, Hensel N, Lewalle P, Couriel D, Kreitman RJ, Pastan I, Barrett AJ. Specific depletion of alloreactivity against haplotype mismatched related individuals by a recombinant immunotoxin: a new approach to graft-versus-host disease prophylaxis in haploidentical bone marrow transplantation. Bone Marrow Transplant. 1996 May;17(5):793-9.

Mavroudis DA, Dermime S, Molldrem J, Jiang YZ, Raptis A, van Rhee F, Hensel N, Fellowes V, Eliopoulos G, Barrett AJ. Specific depletion of alloreactive T cells in HLA-identical siblings: a method for separating graft-versus-host and graft-versus-leukaemia reactions. Br J Haematol. 1998 Jun;101(3):565-70.

Study ID Numbers:	990037, 99-H-0037
Study First Received:	November 3, 1999
Last Updated:	November 13, 2009
ClinicalTrials.gov Identifier:	NCT00001872 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Volunteer
Leukocyte Donors
Family Members
Leukocyte Collection
No Reimbursement

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Immune System Diseases

Hematologic Neoplasms
Hematologic Diseases
Graft vs Host Disease

ClinicalTrials.gov processed this record on November 27, 2009