Ignite Creation Date:
2024-05-05 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00741325
Status:
COMPLETED
Last Update Posted:
2014-02-11
First Post:
2008-08-22
Brief Title:
Long-Term Follow-up Study for Non-Hodgkins Lymphoma Patients Who Received Study Treatment Plerixafor or Placebo in the AMD3100-3101 Study NCT00103610
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Long-term Observational Follow-up Study of a Multicenter Randomized Double-blind Placebo-controlled Comparative Trial of AMD3100 240µgkg Plus G-CSF 10µgkg Versus G-CSF 10µgkg Plus Placebo to Mobilize and Collect 5X 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:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a long-term observational study of patients that were treated with at least 1 dose of study treatment plerixafor or placebo in the AMD3100-3101 protocol NCT00103610
Detailed Description:
This is a long-term observational study of patients who received at least one dose of study treatment plerixafor or placebo in a multicenter randomized double blind placebo-controlled investigational study to evaluate granulocyte colony stimulating factor G-CSF plus AMD3100 versus G-CSF plus placebo to mobilize and transplant Non-Hodgkins Lymphoma NHL patients protocol AMD3100-3101 NCT00103610 The objective of this study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment placebo or plerixafor for a period of 5 years following the first dose of study treatment placebo or plerixafor in protocol AMD3100-3101 NCT00103610
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