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

Graft vs Host Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001872
• Other study ID #: 990037
• Secondary ID: 99-H-0037
• Status: Completed
• Start date: February 2, 1999
• Est. completion date: March 2, 2018

Study information

• Verified date: March 2, 2018
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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....

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Graft vs Host Disease
• Hematologic Neoplasm
• Hematologic Neoplasms

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation