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

NCT ID: NCT00001872

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-02-02

Study Completion Date

2018-03-02

Brief Summary

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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....

Detailed Description

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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.

Conditions

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Graft vs Host Disease Hematologic Neoplasm

Keywords

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Volunteer Leukocyte Donors Family Members Leukocyte Collection No Reimbursement

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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A. John Barrett, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Heart, Lung, and Blood Institute (NHLBI)

Locations

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National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 7858526 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8733700 (View on PubMed)

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. doi: 10.1046/j.1365-2141.1998.00748.x.

Reference Type BACKGROUND
PMID: 9633903 (View on PubMed)

Other Identifiers

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99-H-0037

Identifier Type: -

Identifier Source: secondary_id

990037

Identifier Type: -

Identifier Source: org_study_id