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T-Cell Depletion in Unrelated Donor Marrow Transplantation (TCD)

Clinical Trials URL: http://www.clinicaltrials.gov/ct/sh...
Study Type: Clinical Trial
Prepared on October 13, 2008
Last Updated on November 10, 2005
Study Dates: 1993-2005
Consent: Unrestricted Consent
Commercial Use Restrictions: No
NHLBI Division: DBDR
Collection Type: Open BioLINCC Study - See bottom of this webpage for request information

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.

Subjects

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)