Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004874
Status:
TERMINATED
Last Update Posted:
2018-01-17
First Post:
2000-03-07
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Expanded Access Study of Iodine-131 Anti-B1 Antibody for RelapsedRefractory Low-Grade and Transformed Low-Grade Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of FDA approval
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
PURPOSE Phase III trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory non-Hodgkins lymphoma
PURPOSE Phase III trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the efficacy and safety of iodine I 131 monoclonal antibody anti-B1 in patients with relapsed or refractory low grade or transformed low grade B-cell non-Hodgkins lymphoma
OUTLINE On day 1 patients receive unlabeled monoclonal antibody anti-B1 MOAB anti-B1 IV over 1 hour followed by a tracer dose of iodine I 131 MOAB anti-B1 IV over 30 minutes to determine biodistribution and a therapeutic dose of iodine I 131 MOAB anti-B1 Patients receive unlabeled MOAB anti-B1 IV over 1 hour followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 30 minutes on day 8 Patients are followed at weeks 13 and 25 and then every 6 months for up to 2 years
PROJECTED ACCRUAL Expanded Access Trial no maximum accrual
OUTLINE On day 1 patients receive unlabeled monoclonal antibody anti-B1 MOAB anti-B1 IV over 1 hour followed by a tracer dose of iodine I 131 MOAB anti-B1 IV over 30 minutes to determine biodistribution and a therapeutic dose of iodine I 131 MOAB anti-B1 Patients receive unlabeled MOAB anti-B1 IV over 1 hour followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 30 minutes on day 8 Patients are followed at weeks 13 and 25 and then every 6 months for up to 2 years
PROJECTED ACCRUAL Expanded Access Trial no maximum accrual
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COULTER-CP-98-020 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA036727 |
| P30CA036727 | NIH | None | None |
| UNMC-259-98 | None | None | None |