Ignite Creation Date:
2024-05-05 @ 10:36 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01149863
Status:
COMPLETED
Last Update Posted:
2013-12-13
First Post:
2010-06-22
Brief Title:
Alteration in Timing of Plerixafor Administration
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
WCI1680-09 Evaluation of Alterations in Time of Administration of Plerixafor Mozobil AMD3100 in Combination With G-CSF on Safety and CD34 Cell Mobilization
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Typically the collection of blood cells for autologous stem cell transplant is done after the drugs granulocyte colony-stimulating factor G-CSF and plerixafor have been given to activate the bone marrow stem cells to produce a certain type of blood cell called CD34 cells Currently plerixafor is given in the evening about 11 hours before apheresis removal of blood begins the following morning The purpose of this study is to test whether plerixafor can instead be given 17 hours before apheresis This timing would be more convenient since plerixafor would be given during normal clinic hours and so patients would be within a clinic environment if any side effects develop
The study will look for the activation of CD34 cells in patients who receive plerixafor 17 hours before apheresis We will follow the number of patients that achieve the target numbers of CD34 cells and the total number of CD34 cells collected These will be compared to the numbers in previous studies giving plerixafor 11 hours before apheresis
We will also assess the safety of giving plerixafor 17 hours before apheresis
The study will look for the activation of CD34 cells in patients who receive plerixafor 17 hours before apheresis We will follow the number of patients that achieve the target numbers of CD34 cells and the total number of CD34 cells collected These will be compared to the numbers in previous studies giving plerixafor 11 hours before apheresis
We will also assess the safety of giving plerixafor 17 hours before apheresis
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WCI1680-09 | OTHER | Other | None |