LLME Treated Cellular Immunotherapy Following T-cell Depleted Allogeneic Heamtopoietic Stem Cell Transplantation for Acceleration of Immune Reconstitution
If you agree to participate in this research study you will be evaluated during the 4th-6th
week after your transplant to determine the number of CD4 cells in your circulation and to
determine that your body has eliminated all of the immune suppressing medicines used around
the time of your transplant. This will be performed by studying the cells from two tubes of
blood. Thereafter, blood cells will be obtained from your donor (the same donor as used for
the transplant). These cells from the donor will be treated with LLME in the laboratory.
The cells will then be washed to eliminate the LLME, counted, and the desired number will be
administered to you by transfusion.
Four to six weeks later, you will have additional blood drawn (2-3 teaspoons) to determine
the number of CD4 cells in your blood. If the number is below 100, you will be given
another transfusion of LLME treated cells, but you will receive a larger number of cells.
Above 100 CD4 cells, the risk of infections appears to decrease. This will be repeated
every 8 weeks provided that you and your donor remain willing to continue until one of three
things happens. The three things that would cause us to stop further DLI would be: (1) you
develop a CD4 count of over 100, (2) you develop evidence of GVHD, or (3) we reach the
maximum practical number of cells which your donor could provide.
Your donor will also be reevaluated by medical history, physical examination, and blood
tests to ensure that he/she remains healthy and can undergo the cell donation procedure
safely. He or she will donate the first doses of white cells by drawing a small amount of
blood. Later donations, if necessary, will be collected in a manner that is very similar to
how platelets are normally collected from volunteer donors by the blood bank. The manner in
which the transfusions are given will be similar to that in which you have received red
blood cell and platelet transfusions in the past.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Neal Flomenberg, M.D.
Thomas Jefferson University, Department of Medical Oncology
United States: Institutional Review Board
|Thomas Jefferson University Hospital||Philadelphia, Pennsylvania 19131|