Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004192
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2000-01-21
Brief Title:
Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkins Lymphoma
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
A Randomized Multicenter Open-Label Study of Single Dose Filgrastim-SD01 Versus Daily Filgrastim Following ESHAP Chemotherapy for Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-12
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:
RATIONALE Colony-stimulating factors may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Randomized phase II trial to compare the effectiveness of filgrastim-SD01 with that of filgrastim to relieve the neutropenia following combination chemotherapy in patients who have non-Hodgkins lymphoma
PURPOSE Randomized phase II trial to compare the effectiveness of filgrastim-SD01 with that of filgrastim to relieve the neutropenia following combination chemotherapy in patients who have non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Compare the effect of single dose filgrastim-SD01 vs daily filgrastim G-CSF on the duration of neutropenia in course 1 after combination chemotherapy in patients with recurrent non-Hodgkins lymphoma II Compare the effect of these regimens on duration of neutropenia in courses 2-4 absolute neutrophil counts ANC in courses 1-4 time to ANC recovery in courses 1-4 and safety in these patients III Determine the pharmacokinetic profile of these drugs in course 1 in these patients
OUTLINE This is a randomized open label multicenter study Patients are randomized to one of two treatment arms All patients receive etoposide IV over 1 hour on days 1-4 cisplatin IV continuously on days 1-4 methylprednisolone IV over 15 minutes on days 1-5 and cytarabine IV over 2 hours on day 5 Treatment is repeated every 21 days for up to 4 courses Arm I Patients receive filgrastim-SD01 subcutaneously SQ on day 6 Arm II Patients receive filgrastim G-CSF SQ daily beginning on day 6 and continuing for 12 days or until blood counts recover
PROJECTED ACCRUAL A total of 60 patients 30 per arm will be accrued for this study within at least 6 months
OUTLINE This is a randomized open label multicenter study Patients are randomized to one of two treatment arms All patients receive etoposide IV over 1 hour on days 1-4 cisplatin IV continuously on days 1-4 methylprednisolone IV over 15 minutes on days 1-5 and cytarabine IV over 2 hours on day 5 Treatment is repeated every 21 days for up to 4 courses Arm I Patients receive filgrastim-SD01 subcutaneously SQ on day 6 Arm II Patients receive filgrastim G-CSF SQ daily beginning on day 6 and continuing for 12 days or until blood counts recover
PROJECTED ACCRUAL A total of 60 patients 30 per arm will be accrued for this study within at least 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G99-1648 | REGISTRY | National Cancer Institute | httpsreporternihgovquickSearchP30CA036727 |
| P30CA036727 | NIH | None | None |
| AMGEN-990117 | OTHER_GRANT | None | None |
| CWRU-AMGN-1499 | OTHER | None | None |
| UCLA-9906080 | OTHER | None | None |