Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396201
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2006-11-02
Brief Title:
AMD3100 Plerixafor Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor G-CSF to Increase the Number of Peripheral Blood Stem Cells PBSCs in Patients With Hodgkins Disease
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Treatment With AMD3100 Added to a Mobilizing Regimen of G-CSF to Increase the Number of Peripheral Blood Stem Cells in Patients With Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2014-02
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:
Participants with Hodgkins Disease HD who have been treated with cyto-reductive chemotherapy who are to undergo autologous stem cell transplantation and who meet the inclusionexclusion criteria are eligible to enter this efficacy safety and pharmacokinetic PK study The only changes to the standard of care is the addition of plerixafor to a granulocyte-colony stimulating factor G-CSF mobilization regimen on each day prior to apheresis The purpose of this protocol is to determine the proportion of participants who reach a target number of CD34 stem cells 5106 cellskg after hematopoietic stem cell mobilization with G-CSF and plerixafor Safety and PK parameters are also collected
Detailed Description:
Participants with HD who have been treated with cyto-reductive chemotherapy who are to undergo autologous stem cell transplantation and who meet the inclusionexclusion criteria are eligible to enter this study The only changes to the standard of care is the addition of plerixafor to a G-CSF mobilization regimen on the day prior to apheresis and the collection of blood samples for pharmacokinetic PK analysis and pharmacodynamics PD analysis by CD34 fluorescence-activated cell sorting FACS analysis Blood samples for PK and CD34 FACS analyses will be obtained prior to and after the first dose of plerixafor Participants will undergo mobilization with G-CSF 10 µgkg daily and will receive plerixafor 240 µgkg on each day prior to apheresis Participants will be apheresed for up to 5 consecutive days in order to collect the target number of CD34 stem cells 5106 cellskg After apheresis all participants will be treated with high dose chemotherapy in preparation for transplantation Participants will be transplanted with cells obtained from the G-CSF plus plerixafor mobilization regimen In the event that a sufficient number of cells for transplantation are not obtained from the collection cells may be retained and pooled for transplantation at the investigators discretion
The primary endpoint is the proportion of HD participants who collect 5106 CD34 cellskg with this mobilization regimen The secondary endpoints include the safety of this mobilization regimen the proportion of participants who collect 2106 CD34 cellskg the change in CD34 cells circulating in the peripheral blood after a dose of plerixafor and the number of days of apheresis required to obtain 5106 CD34 cellskg In addition success of the transplantation will be evaluated by measuring the time to engraftment of PMNs and PLTs Participants will be followed for 12 months to assess transplant durability
This study was previously posted by AnorMED Inc In November 2006 AnorMED Inc was acquired by Genzyme Corporation Genzyme Corporation is the sponsor of the trial
The primary endpoint is the proportion of HD participants who collect 5106 CD34 cellskg with this mobilization regimen The secondary endpoints include the safety of this mobilization regimen the proportion of participants who collect 2106 CD34 cellskg the change in CD34 cells circulating in the peripheral blood after a dose of plerixafor and the number of days of apheresis required to obtain 5106 CD34 cellskg In addition success of the transplantation will be evaluated by measuring the time to engraftment of PMNs and PLTs Participants will be followed for 12 months to assess transplant durability
This study was previously posted by AnorMED Inc In November 2006 AnorMED Inc was acquired by Genzyme Corporation Genzyme Corporation is the sponsor of the trial
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