Leukemia, Myeloid, Acute Clinical Trial
Official title:
Transfusion of CD45RA-depleted Donor Lymphocytes to Improve Regeneration of Antimicrobial Immunity After TCR-alpha/Beta Depleted Hematopoietic Stem Cell Transplantation
The stud will evaluate whether infusions of CD45RA-depleted lymphocytes from the donor early post-transplant is a safe way to improve immunity to common infections in recipients of TCR-alpha/beta depleted hematopoietic stem cell grafts.
Graft-versus-host disease (GVHD) remains the most important direct complication of
hematopoietic stem cell transplantation. Methods used to prevent GVHD include diverse
pharmacologic interventions and ex vivo methods of T-cell depletion, the latter being the
most effective ones. Historically depletion of T-cells from the graft is associated with
increased rate of graft failure, relapse of malignant disease and prolonged immune
deficiency. Selective depletion of TCR-alpha/beta T-lymphocytes is a new method of
hematopoietic stem cell graft manipulation which is thought to conserve important cell
populations, e.g. NK cells and gamma/delta T cells within the graft. Preliminary results
suggest that TCR alpha/beta depletion ensures high engraftment rate, low early mortality and
good control of GVHD. The problem of delayed immune reconstitution and life-threatening
viral infections remains incompletely resolved.
Depletion of naive (CD45RA-positive) T-cells was developed as a new method of graft
manipulation to prevent GVHD. Research data indicate that alloreactivity is associated
mainly with naive T-cell fraction. In vitro depletion of CD45RA lowers significantly the
alloreactive response while retaining reactivity to pathogens.
In the current protocol we plan to test whether relatively low doses of CD45RA-depleted
mononuclear cells can be safely infused after TCR-alpha/beta depleted transplantation. The
biologic readout for the protocol will be quantitative assessment of T-cell reactivity to
common pathogens after infusion.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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