A Randomized Comparison of Dendritic Cell Content and T-Cell Phenotype Between G-CSF(Granulocyte Colony-Stimulating Factor)or G-CSF+GM-CSF (Granulocyte Macrophage Colony-Stimulating Factor) for the Mobilization of Normal Allogeneic Peripheral Blood Stem Cell Donors
Patients with leukemia will receive a stem cell transplant, prior to which they will receive
medication and/or radiation to destroy all leukemia cells as well as other blood cells. In
order to survive this treatment, patients will need to be given the stem cells from another
person to replace the blood cells killed by the treatment.
The stem cells given to the recipient will be collected from a relative. To increase the
number of stem cells in the relative, he/she is given a growth factor to increase the number
of stem cells prior to collection. The standard growth factor used is called
G-CSF(Granulocyte Colony-Stimulating Factor ). In this research study, the physician will
give the relative either G-CSF or a combination of G-CSF and GM-CSF (Granulocyte Macrophage
(GM)) , another type of growth factor. Whether the relative receives G-CSF or GM-CSF will
be determined by chance. The donors will be randomized to one or the other. It is not known
if the stem cells and white blood cells collected using one or both growth factors results
in more cures for this disease and fewer side effects, such as graft-versus-host disease.
The reason for doing the study is to determine if the stem cells and other white blood cells
collected are any different when different growth factors are given, and to see how well the
patient does. The stem cell transplant will in every other way be the same. The only
difference is that if the recipient and donor decide to be in this study, the donor will
either be given only G-CSF or the combination of G-CSF and GM-CSF and the recipient will
receive the stem cells collected.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft
at transplant (1 day)
No
Sagar Lonial, MD
Principal Investigator
Emory University Winship Cancer Institute
United States: Institutional Review Board
0693-2002
NCT00208949
September 2002
May 2012
Name | Location |
---|---|
Emory University Winship Cancer Institute | Atlanta, Georgia 30322 |