Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421395
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2007-01-11
Brief Title:
Safety Study of NHL With 90Y-hLL2 IgG
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
Phase III Radioimmunotherapy of Non-Hodgkins Lymphoma With Radiolabeled Humanized IMMU-LL2 Treatment With 90Y-hLL2 IgG
Status:
COMPLETED
Status Verified Date:
2008-01
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 will be an open label multiple center non-randomized dose-escalation Phase III trial designed to evaluate the safety and effectiveness of a repeated outpatient regimen utilizing IMMU-hLL2 intact monoclonal antibody IgG labeled with different doses of 90Y for the treatment of patients B-cell lymphoma NHL
Detailed Description:
90Y-labeled hLL2 will be administered according to a schedule based upon whether or not a patient had prior high-dose chemotherapy with a marrow or stem cell transplant Patients with both indolent and aggressive types of NHL will be enrolled at each dose level without segregation However at the conclusion of the trial with the maximum tolerated dose MTD defined a minimum number of 6 patients with indolent NHL 6 patients with aggressive NHL and 6 patients with 25 bone marrow involvement will be studied at that dose level
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