Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115193
Status:
COMPLETED
Last Update Posted:
2013-08-29
First Post:
2005-06-21
Brief Title:
Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkins Lymphoma
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Multicenter Double-Blind Randomized Study of Pegfilgrastim Administered on the Same Day or the Next Day of R-Chop Chemotherapy in Subjects With Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-08
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 purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy as measured by the duration of grade 4 neutropenia
Detailed Description:
This was a multicenter double-blind randomized phase 2 study of pegfilgrastim given either the same day as or the day after a chemotherapy regimen consisting of cyclophosphamide doxorubicin vincristine prednisone and rituximab R-CHOP
Chemotherapy was administered every 21 days for up to 6 cycles in subjects with aggressive non-Hodgkins lymphoma NHL mantle cell or diffuse large B-cell lymphoma Subjects were administered R-CHOP on day 1 of each cycle All subjects were randomized to 1 of 2 treatment arms arm A subjects were administered pegfilgrastim 6 mg on day 1 of each cycle within 4 hours of chemotherapy completion arm B subjects were administered pegfilgrastim 6 mg on day 2 of each cycle at least 24 hours after chemotherapy completion All subjects were administered placebo on the day they did not receive pegfilgrastim A total of 77 subjects were enrolled at 24 centers across the US Protocol treatment duration for subjects was up to 18 weeks 6 three-week cycles
Chemotherapy was administered every 21 days for up to 6 cycles in subjects with aggressive non-Hodgkins lymphoma NHL mantle cell or diffuse large B-cell lymphoma Subjects were administered R-CHOP on day 1 of each cycle All subjects were randomized to 1 of 2 treatment arms arm A subjects were administered pegfilgrastim 6 mg on day 1 of each cycle within 4 hours of chemotherapy completion arm B subjects were administered pegfilgrastim 6 mg on day 2 of each cycle at least 24 hours after chemotherapy completion All subjects were administered placebo on the day they did not receive pegfilgrastim A total of 77 subjects were enrolled at 24 centers across the US Protocol treatment duration for subjects was up to 18 weeks 6 three-week cycles
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