Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041730
Status:
UNKNOWN
Last Update Posted:
2009-09-30
First Post:
2002-07-15
Brief Title:
Rituxan Plus FavId Idiotype Vaccine for Low-grade Non-Hodgkins Lymphoma
Sponsor:
Favrille
Organization:
Favrille
Study Overview
Official Title:
Phase II Trial of RituxanR Plus FavIdTM Tumor-Specific Idiotype-KLH and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma
Status:
UNKNOWN
Status Verified Date:
2004-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the ability of patients treated with Rituxan plus FavId and GM-CSF to mount an immune response humoral andor cellular to KLH and their idiotype
Detailed Description:
The purpose of this study is to evaluate the ability of patients treated with Rituxan plus FavId and GM-CSF to mount an immune response humoral andor cellular to KLH and their idiotype Secondary objectives are the determination of overall objective response rate duration of response and time to progression B-cell malignancies express a unique antigen the immunoglobulin idiotype Id on their surface Each B-cell harbors a unique genetic sequence used in production of unique Id protein No normal B-cells possess that Id on their cell surface Hence Id protein should serve as an ideal target for individualized active immune therapy of NHL Many of the antigens expressed by tumors including Id are only weak immunogens To augment the immune response against Id the Id protein must be chemically coupled to a strongly immunogenic protein keyhole limpet hemocyanin KLH is a commonly used protein carrier capable of augmenting the bodys immune reaction against Id protein For vaccines which produce primarily an antibody response there is a concern that combining immunotherapy with Rituxan which produces a rapid and sustained up to 6 to 9 months post-treatment in 83 of patients depletion of circulating and tissue-based B-cells would blunt any antibody response For vaccines that induce strong T-cell responses like Id-KLH plus GM-CSF there is evidence in mice that depleting the host of B-cells could actually increase the T-cell response to the vaccine GM-CSF is a hematopoietic growth factor that stimulates T-cell proliferation T-cell response to both the patients Idiotype and KLH will be measured during this trial
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