NCT00001872

Brief Summary

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....

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
18.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2018

Completed
Last Updated

December 17, 2019

Status Verified

March 2, 2018

First QC Date

November 3, 1999

Last Update Submit

December 14, 2019

Conditions

Keywords

VolunteerLeukocyte DonorsFamily MembersLeukocyte CollectionNo Reimbursement

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 7858526BACKGROUND
  • 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.

    PMID: 8733700BACKGROUND
  • 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.

    PMID: 9633903BACKGROUND

MeSH Terms

Conditions

Graft vs Host DiseaseHematologic Neoplasms

Condition Hierarchy (Ancestors)

Immune System DiseasesNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • A. John Barrett, M.D.

    National Heart, Lung, and Blood Institute (NHLBI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

February 2, 1999

Study Completion

March 2, 2018

Last Updated

December 17, 2019

Record last verified: 2018-03-02

Locations