Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091676
Status:
UNKNOWN
Last Update Posted:
2012-02-03
First Post:
2004-09-15
Brief Title:
Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma
Sponsor:
Biovest International
Organization:
Biovest International
Study Overview
Official Title:
Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype FNHLId1 With Local GM-CSF in First Complete Remission
Status:
UNKNOWN
Status Verified Date:
2012-02
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:
BiovaxID
Brief Summary:
The primary objective of this Phase 3 study is to definitively confirm the safety and efficacy of BiovaxId an autologous tumor derived immunoglobulin idiotype vaccine as measured by a significant prolongation of the period of disease free survival when administered to patients with indolent follicular Non-Hodgkins Lymphoma NHL during their first complete remission
Detailed Description:
Patients with Stage III-IV follicular lymphoma and tumor 2cm Stage II allowed if tumor 5cm previously untreated by other than local radiation provide tumor material by tissue biopsy for production of a patient-specific Ig idiotype vaccine conjugated to the immunogenic protein KLH After completing PACE or CHOP-R chemotherapy and achieving a complete remission followed by a waiting period to reconstitute the immune system patients who remain in remission randomized to the active treatment arm receive a series of 5 idiotype vaccinations accompanied by the immune stimulant GM-CSF Patients randomized to the control arm receive a time-matched series of KLH injections also accompanied by GM-CSF Patients are subsequently studied to observe their immune responses both to the non-specific immune stimulating agents and for the specific immune response to the vaccine Patients are followed for a minimum of 4 years post-randomization or until relapse
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