A Phase II Study Using the CliniMACS® Device for CD34+ Cell Selection and T Cell Depletion for Graft-versus-Host Disease Prophylaxis in Alternative Donor Stem Cell Transplant Recipients
A major issue in alternative donor (mismatched related and unrelated donor transplantation
is the development of graft-versus-host disease (GVHD). Several clinical trials have shown
that the use of T-cell depleted peripheral blood stem cells (PBSC) reduces GVHD in
alternative donor transplants. The purpose of this study is to determine the ability of
CD34 positive selection and T cell depletion using the CliniMACS® Device as the only GVHD
prophylaxis to prevent severe acute GVHD in recipients of an alternative donor PBSC
transplant. Mismatched related donors will match at least 3 of 6 Human leukocyte
antigens(HLA)(haplocompatible) and unrelated donors will match at least 6 out of 8 HLA
antigens with the transplant recipient. The conditioning therapy including chemotherapy,
anti-thymocyte globulin (ATG), +/- total body irradiation (TBI) will be based on the
patient's diagnosis. The transplant recipient will be followed for 5 years after transplant
for GVHD, engraftment, post-transplant infections, disease relapse, and overall survival.
In addition, this study will serve as a platform for a companion study of therapy to
accelerate immune recovery after transplant.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine rate of severe GVHD.
Within 30 days after stem cell transplant
Andrew Gilman, MD
Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System
United States: Food and Drug Administration
LCH BMT 09-01
|Levine Children's Hospital, Carolinas Medical Center||Charlotte, North Carolina 28204|