A Phase I/II Study of Llme Treated Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematological Malignancies
We believe that the risks of allogeneic transplant can be drastically reduced if the
following criteria can be met: (1) consistent engraftment, (2) little or no GVHD with the
ability to rapidly withdraw immune suppression, (3) rapid recovery of CD4 counts to levels
greater than 200 cells/micro liter. Our prior (ongoing) trial attempts to address how LLME
treated T cells given as DLI can address points 2 and 3 above. The current study addresses
how treatment of the CD34- fraction of the graft attempts to address points 1 and 2 (and to
a lesser extent point 3) above. We believe that if these points can be consistently
achieved that the mortality of allogeneic HSCT may be reduced to levels more akin to those
of autologous HSCT. We propose to test the hypothesis that LLME-treated T cells will be
safe with regard to reducing GVHD or other infusion related toxicities and that their
administration as part of the transplant will facilitate engraftment. We believe that this
approach will ultimately be an important step in a variety of transplant settings ranging
from matched siblings to haplodisparate donors.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of CD34+ Stem Cell Infusions followed by LLME
Determine the safety of CD34+ stem cell infusions followed by the LLME treated CD34- fraction. This includes monitoring the patients for any side effects associated with the LLME treated cell infusion or any other unexpected adverse events. This regimen will be gauged as to its safety using 100 day mortality as the measured endpoint. Deaths from all causes will be included.
Through 100 days post-transplant or death
Yes
John Wagner, MD
Principal Investigator
Thomas Jefferson University
United States: Food and Drug Administration
04U.115
NCT00429416
March 2004
May 2009
Name | Location |
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Thomas Jefferson University` | Philadelphia, Pennsylvania 19107 |