Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347971
Status:
COMPLETED
Last Update Posted:
2008-09-05
First Post:
2006-06-30
Brief Title:
Study of Recombinant Interleukin 21 in Combination With Rituxan for Non-Hodgkins Lymphoma
Sponsor:
ZymoGenetics
Organization:
ZymoGenetics
Study Overview
Official Title:
Phase 1 Open-Label Dose-Escalation Study to Assess the Safety and Pharmacokinetics of Recombinant Interleukin 21 rIL-21 Administered in Combination With Rituxan Rituximab in Subjects With B-Cell Non Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2008-09
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 the study is to evaluate whether recombinant IL-21 used in combination with rituximab is safe for patients with non-Hodgkins lymphoma NHL
Detailed Description:
This is a Phase 1 open-label dose-escalation study of rituximab rIL-21 combination therapy administered once weekly for 4 weeks following an initial treatment with one dose of rituximab alone to patients with B-cell non-Hodgkins lymphoma NHL who have failed prior therapyies A standard dose of rituximab will be used Increasing doses of rIL-21 will be studied sequentially in different groups of patients starting with 30 μgkg
Before starting treatment with rituximab rIL-21 patients will be treated with one dose of rituximab alone to look for rituximab infusion-related symptoms such as fever chills and rigors Patients who have severe infusion-related side effects after the first dose of rituximab will not go on to receive IL-21 Those who do not have unacceptable rituximab-related side effects will receive intravenous rIL-21 at least 60 minutes after completing the rituximab infusion at the rest of the weekly dosing visits Patients will be evaluated for safety over the course of the study Disease evaluation tumor restaging will be performed 2 weeks following completion of the first 4-week treatment cycle Patients with stable disease or better at this evaluation may go on to receive a second 4-week treatment cycle of rituximab rIL-21 Patients may be in the study for 2 to 4 months
Before starting treatment with rituximab rIL-21 patients will be treated with one dose of rituximab alone to look for rituximab infusion-related symptoms such as fever chills and rigors Patients who have severe infusion-related side effects after the first dose of rituximab will not go on to receive IL-21 Those who do not have unacceptable rituximab-related side effects will receive intravenous rIL-21 at least 60 minutes after completing the rituximab infusion at the rest of the weekly dosing visits Patients will be evaluated for safety over the course of the study Disease evaluation tumor restaging will be performed 2 weeks following completion of the first 4-week treatment cycle Patients with stable disease or better at this evaluation may go on to receive a second 4-week treatment cycle of rituximab rIL-21 Patients may be in the study for 2 to 4 months
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