Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510133
Status:
COMPLETED
Last Update Posted:
2019-07-09
First Post:
2007-07-30
Brief Title:
A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia AML
Sponsor:
Asterias Biotherapeutics Inc
Organization:
Asterias Biotherapeutics Inc
Study Overview
Official Title:
A Phase II Study of Active Immunotherapy With GRNVAC1 Autologous Mature Dendritic Cells Transfected With mRNA Encoding Human Telomerase Reverse Transcriptase in Patients With Acute Myelogenous Leukemia in Complete Clinical Remission
Status:
COMPLETED
Status Verified Date:
2019-07
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:
This is a phase II study to evaluate the safety feasibility and efficacy of immunotherapy with GRNVAC1 in patients with AML
Detailed Description:
This is a multicenter open-label evaluation of feasibility safety and immunotherapy in patients with AML in complete clinical remission Patients will undergo leukapheresis prior to or shortly after completing consolidation chemotherapy Dendritic cells will be transfected with the messenger RNA encoding human telomerase reverse transcriptase hTERT and a portion of the lysosome-associated membrane protein LAMP-1 LAMP matured aliquoted and cryopreserved The final autologous vaccine product is referred to as GRNVAC1 Patients will be vaccinated with weekly for 6 weekswill rest for 4 weeks then will receive 6 boost injections each administered every other week for 12 weeks Patients will be followed every 4 weeks until Week 54 then every 3 months for 1 year then every 6 months up to approximately 5 years from the first vaccination or until relapseprogression
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