Viewing Study NCT00004192



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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
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

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