Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003338
Status:
UNKNOWN
Last Update Posted:
2021-08-16
First Post:
1999-11-01
Brief Title:
Monoclonal Antibodies in Detecting Residual Disease in Patients Who Have Been Treated for Non-Hodgkins Lymphoma
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
The Utility of LymphoScan Imaging in the Dectection of Residual Tumor After Chemotherapy andor Radiotherapy in Patients With Non-Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2001-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Diagnostic imaging procedures such as radiolabeled monoclonal antibodies may improve the ability to detect the residual disease in patients who have been treated for non-Hodgkins lymphoma
PURPOSE Phase IIIII trial to study the effectiveness of monoclonal antibodies in detecting residual disease in patients who have been treated for non-Hodgkins lymphoma
PURPOSE Phase IIIII trial to study the effectiveness of monoclonal antibodies in detecting residual disease in patients who have been treated for non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Evaluate the safety of multiple 2-3 administrations of technetium Tc 99m LL2 monoclonal antibody LymphoScan in patients with B-cell non-Hodgkins lymphoma after chemotherapy andor radiotherapy II Describe human antimouse antibody production in these patients III Demonstrate that addition of a single LymphoScan study to conventional diagnostic modalities CDMs can differentiate between tumor and residual scarring IV Determine the diagnostic operating characteristics of LymphoScan to detect residual tumor in patients with radiologically detectable masses V Compare patient management plans based on CDMs alone and both CDMs and LymphoScan
OUTLINE This is an open label multicenter study Patients receive an infusion of technetium Tc 99m LL2 monoclonal antibody LymphoScan by IV injection or infused over 20-30 minutes after completion of therapy as part of the response evaluation procedures Planar images are acquired between 4-8 hours and 18-24 hours following antibody injection and single photon emission computerized tomography SPECT imaging is performed between 4-8 hours following antibody injection Patients may receive a repeat injection of LymphoScan Patients are followed for 3 to 6 months
PROJECTED ACCRUAL There will be 60 patients accrued into this study
OUTLINE This is an open label multicenter study Patients receive an infusion of technetium Tc 99m LL2 monoclonal antibody LymphoScan by IV injection or infused over 20-30 minutes after completion of therapy as part of the response evaluation procedures Planar images are acquired between 4-8 hours and 18-24 hours following antibody injection and single photon emission computerized tomography SPECT imaging is performed between 4-8 hours following antibody injection Patients may receive a repeat injection of LymphoScan Patients are followed for 3 to 6 months
PROJECTED ACCRUAL There will be 60 patients accrued into this study
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 |
|---|---|---|---|
| NCI-V98-1418 | None | None | None |
| IM-D-LL2-06 | None | None | None |