Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208949
Status:
TERMINATED
Last Update Posted:
2012-09-14
First Post:
2005-09-13
Brief Title:
A Comparison of Dendritic Cell Content and T-Cell Phenotype Between Granulocyte Colony-Stimulating Factor G-CSF or G-CSF Granulocyte Macrophage GM-CSF
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Randomized Comparison of Dendritic Cell Content and T-Cell Phenotype Between G-CSFGranulocyte Colony-Stimulating Factoror G-CSFGM-CSF Granulocyte Macrophage Colony-Stimulating Factor for the Mobilization of Normal Allogeneic Peripheral Blood Stem Cell Donors
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study involving patients who are undergoing allogeneic peripheral blood stem cell transplantation Both donors and recipients are being sought for this study
Detailed Description:
Patients with leukemia will receive a stem cell transplant prior to which they will receive medication andor 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 heshe is given a growth factor to increase the number of stem cells prior to collection The standard growth factor used is called G-CSFGranulocyte 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
The stem cells given to the recipient will be collected from a relative To increase the number of stem cells in the relative heshe is given a growth factor to increase the number of stem cells prior to collection The standard growth factor used is called G-CSFGranulocyte 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None