T-Cell Depletion in Unrelated Donor Marrow Transplantation (TCD)
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Accession Number
HLB00480505a
Study Type
Clinical Trial
Collection Type
Open BioLINCC Study
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Study Period
1993-2005
NHLBI Division
DBDR
Dataset(s) Last Updated
January 3, 2018
Clinical Trial URLs
https://clinicaltrials.gov/ct/show/NCT00000591
Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pubmed/16125590
Consent
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Objectives
To evaluate the impact of ex vivo T-Cell Depletion of marrow as compared with unmodified grafts on disease-free survival in recipients of unrelated donor bone marrow transplants.
Background
Chronic graft-versus-host disease (cGVHD) is a major complication and a leading cause of post hematopoietic stem cell transplantion morbidity and mortality. Animal studies suggest that cGVHD is mediated by mature donor T cells that react against disparate recipient histocompatibility antigens. T cell-depletion of donor marrow before infusion into the recipient may ameliorate or prevent GvHD. Unfortunately, since donor T cells also play a key role in mediating graft-versus-tumor (GVT) effects, aggresive GVHD prevention strategies in patients with malignant disease may compromise beneficial antineoplastic GVT effects.
Participants
410 patients with hemotologic malignancies were randomized at 15 participating transplantation centers, 203 patients were randomized to receive t-cell-depleted marrow and cyclosporine (TCD arm) and 207 to receive methotrexate and cyclosporine after transplantation of t-cell-replete marrow.
Conclusions
In spite of a significant reduction of acute GHVD, TCD did not reduce the incidence of cGVHD or improve survival in patients who developed cGVHD. (Blood. 2005; 106(9):3308-3313) Disease-free survival at 3 years did not differ between the intervention groups. (Lancet. 2005 Aug 27-Sep 2;366(9487):733-41)
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Resources Available
Study Datasets OnlyStudy Documents
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