Bethesda, Maryland 20892

  • Hematologic Neoplasm

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....


Study summary:

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.


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.


Study is Available At:


Original ID:

990037


NCT ID:

NCT00001872


Secondary ID:

99-H-0037


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

14


Enrollment Type:

Actual


Overall Contact Information

Official Name:A. John Barrett, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)

Study Dates

Start Date:February 2, 1999
Completion Date:March 2, 2018
Verification Date:March 2, 2018
Last Changed Date:December 14, 2019
First Received Date:November 3, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Heart, Lung, and Blood Institute (NHLBI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:9633903
Reference Type:Reference
Citation: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:8733700
Reference Type:Reference
Citation:Datta AR, Barrett AJ, Jiang YZ, Guimarães 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:7858526

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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