Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510471
Status:
TERMINATED
Last Update Posted:
2008-03-18
First Post:
2007-07-31
Brief Title:
Personalized Active Immunotherapy Vaccine Therapy and Sargramostim Given After Standard of Care Treatment With Rituximab and Chemotherapy for Initial Treatment With Lymphoma
Sponsor:
Genitope Corporation
Organization:
Genitope Corporation
Study Overview
Official Title:
A Phase 2 Multi-Center Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy Recombinant Idiotype Conjugated to KLH Id-KLH and Administered With GM-CSF in Patients With Follicular Non-Hodgkins Lymphoma fNHL Following Primary Treatment With Rituximab and Chemotherapy R-Chemo
Status:
TERMINATED
Status Verified Date:
2008-03
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 treatment being investigated is a patient- and tumor-specific therapy known as a personalized active immunotherapy Personalized active immunotherapy is an attempt to use a persons own immune system to combat disease Sargramostim aka GM-CSF is given together with the personalized active immunotherapy because it may increase the immune systems response and therefore aid in the effect of the personalized active immunotherapy
This approach has previously been studied in patients with follicular Non-Hodgkins lymphoma and other B-cell malignancies Encouraging efficacy results and a favorable safety profile have been seen to date in these studies
This approach has previously been studied in patients with follicular Non-Hodgkins lymphoma and other B-cell malignancies Encouraging efficacy results and a favorable safety profile have been seen to date in these studies
Detailed Description:
None
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