Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103610
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2005-02-11
Brief Title:
Mobilization of Stem Cells With AMD3100 Plerixafor in Non-Hodgkins Lymphoma Patients
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect 5 106 CD34 Cellskg in Non-Hodgkins Lymphoma Patients for Autologous Transplantation
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether the combination of AMD3100 plerixafor and granulocyte colony-stimulating factor G-CSF or generic name filgrastim is better than G-CSF alone to mobilize and collect the optimal number of stem cells in non-Hodgkins lymphoma patients for autologous transplantation
Detailed Description:
A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy Currently filgrastim G-CSF a colony stimulating factor is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood which can then be collected from the peripheral blood by a process called apheresis Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation This study is intended to determine whether the combination of plerixafor with filgrastim is better than filgrastim alone in helping non-Hodgkins lymphoma patients collect at least 5 million stem cells in four or less apheresis sessions
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
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