Multiple Myeloma Clinical Trial
Official title:
Non-Myeloablative HLA-Mismatched Ex-Vivo T-cell Depleted Stem Cell Transplantation for Hematologic Malignancies
The purpose of this study is to determine if recipients of non-myeloablative ex-vivo T-cell depleted peripheral blood (PBSC) stem cell transplantation using a mismatched related donor will have less severe graft versus host disease (GVHD), transplant related mortality, and less graft failure compared to alternative haploidentical stem cell transplantation.
One major obstacle to further advancement in the role of bone marrow transplant (BMT) in
hematological malignancies is graft-versus-host-disease (GVHD), which can best be prevented
by removing T-cells from the donor stem cell product. However, previous experience with
T-cell depletion has been associated with an increased rate of engraftment failure and
leukemic relapse. Another obstacle is that a large fraction of leukemia and lymphomas afflict
older patients who are more prone to GVHD and have co-morbid conditions that prevent them
from being a candidate for BMT.
This trial uses a non-myeloablative conditioning regimen with cyclophosphamide, MEDI-507,
fludarabine, and thymic irradiation followed by a T-cell depleted PBSC infusion. Cyclosporine
is used for GVHD prophylaxis, and tapered beginning on day 35. Data from our mouse model and
previous clinical trials have demonstrated that this approach can induce mixed chimerism
without GVHD, with the potential for conversion of mixed chimerism to full donor
hematopoiesis following donor leukocyte infusions.
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