A Compassionate Release Protocol: Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Allogeneic Transplantation Using a Related Haplo-Identical Donor and Unrelated, Umbilical Cord Blood Donor(s) for the Treatment of High Risk Malignancies or Non-Malignant Disorders Requiring Allogeneic Transplantation
The primary purpose of the study is to provide expanded access of T-cell depleted
haplo-identical stem cells for patients receiving allogeneic transplantation from a related
haplo-identical donor and an unrelated, umbilical cord blood (UUCB) unit(s) for the
treatment of high risk malignancies and non-malignant disorders. The T-cell depleted
haplo-identical stems cells are intended to facilitate early, short-term myeloid engraftment
with the primary goal of minimizing early infections and other non-relapse mortality while
the UUCB cells engraft as the durable and permanent graft. Patients with high risk or
refractory malignancies, or non-malignant disorders amenable to stem cell transplantation
therapy but lacking conventional related or unrelated donors will be eligible for this
protocol.
Expanded Access
N/A
Joanne Kurtzberg, MD
Principal Investigator
Duke University
United States: Food and Drug Administration
Pro00045700
NCT01881334
Name | Location |
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Duke University Medical Center | Durham, North Carolina 27710 |