Ignite Creation Date:
2024-05-06 @ 2:01 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01954914
Status:
COMPLETED
Last Update Posted:
2016-09-19
First Post:
2013-09-27
Brief Title:
Plerixafor as a Salvage Regimen to Mobilize Allogeneic Stem Cells in Healthy Volunteers
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
Plerixafor as a Salvage Regimen to Mobilize Allogeneic Stem Cells in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2016-09
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:
MOBIL1
Brief Summary:
With a standard mobilization regimen using G-CSF approximately 5 of allogeneic donors does not mobilize enough CD34 cells to reach an optimal dose for transplantation and are therefore called poor mobilizers A generally accepted optimum CD34 PBSC dose for allogeneic transplantation is 45 x 106kg body weight of the recipient The minimum total CD34 PBSC dose certainly amounts to 2 x 106kg body weight of the recipientThe objective of this trial is to assess the efficacy of a single dose of Plerixafor as salvage procedure in allogeneic stem cell donors with a poor CD34 cell yield after the first day of peripheral blood stem cell collection
Detailed Description:
In this trial the administration of a single dose of Plerixafor 240 µgkg body weight of the donor SC in the evening at 10 PM after frustraneous stem cell apheresis on day 1 will be provided The apheresis on day 2 is performed according to standard recommendations
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