A Study to Accelerate Immune System Recovery Following Stem Cell Transplantation
The purpose of this study is to determine if pre-treating donor lymphocytes with an investigational drug known as L-leucyl-L-leucine methyl ester (LLME, prior to donor lymphocyte infusion (DLI) will improve the recovery of the immune system following stem cell transplant.
ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
Drug: L-leucyl-L-leucine methyl ester (LLME)
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||LLME Treated Cellular Immunotherapy Following T-cell Depleted Allogeneic Heamtopoietic Stem Cell Transplantation for Acceleration of Immune Reconstitution|
|Study Start Date:||September 2000|
|Study Completion Date:||August 2009|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429039
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Neal Flomenberg, M.D.||Thomas Jefferson University, Department of Medical Oncology|