Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066092
Status:
COMPLETED
Last Update Posted:
2008-02-28
First Post:
2003-08-04
Brief Title:
Pegfilgrastim PBPC Mobilization Study
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
Randomized Double-Blind Study of Peripheral Blood Progenitor Cell PBPC Mobilization by Pegfilgrastim or Filgrastim for Autologous Transplantation in Subjects With Hodgkins or Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2008-02
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 randomized double-blind multi-center study to assess the safety and effectiveness of using a single subcutaneous under the skin injection of pegfilgrastim or daily subcutaneous injections of Filgrastim to mobilize stem cells for autologous transplantation in patients with Hodgkins or non-Hodgkins lymphoma
Detailed Description:
This is a research study for Hodgkins Disease and Non-Hodgkins Lymphoma NHL patients who will receive high-dose chemotherapy with autologous peripheral blood stem cell PBSC or PBPC transplant The chemotherapy doses are high enough to severely suppress the bone marrow where blood cells are made and cause very low blood counts A collection of stem cells very young blood cells followed by reinfusion to restore blood counts will be done to stimulate recovery of your blood counts This procedure is called leukapheresis Giving growth factors to patients is a method to increase the number of PBPC that can be collected during leukapheresis This process of giving growth factors to patients is called mobilization moving cells from the bone marrow to the peripheral blood where they can be collected The purpose of this study is to determine if pegfilgrastim an investigational drug can safely and effectively mobilize stem cells Filgrastim also known as NEUPOGEN or G-CSF is approved by the FDA for stem cell mobilization Pegfilgrastim is a modified version of Filgrastim that is longer acting
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