Ignite Creation Date:
2024-05-06 @ 1:13 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01767714
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2012-12-17
Brief Title:
Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5106CD34 Cellskg in Non-Hodgkins Lymphoma NHL Patients for Autologous Transplantation
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-Blind Placebo-Controlled Comparative Trial of Plerixafor 024 mgkg Plus G CSF 10 µgkg Versus G CSF 10 µgkg Plus Placebo to Mobilize and Collect 5 106 CD34 Cellskg in Non-Hodgkins Lymphoma NHL Patients for Autologous Transplantation
Status:
COMPLETED
Status Verified Date:
2014-12
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:
The study is to determine if NHL patients mobilized with G-CSF 10 µgkgday GRAN only plus 024 mgkgday of plerixafor are more likely to achieve a target number of 5 106 CD34 cellskg in 4 or fewer days of apheresis than NHL patients mobilized with G-CSF plus placebo
Detailed Description:
Eligible patients who are unable to achieve adequate apheresis cell counts may enter an Open-Label Rescue Period where they will receive plerixafor following the same study schedule as during the Double-Blind Treatment Period
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 |
|---|---|---|---|
| U1111-1131-0145 | OTHER | UTN | None |
| MOZ14409 | OTHER | None | None |