Ignite Creation Date:
2024-05-05 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00725283
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2008-07-29
Brief Title:
Evaluation of a New Anti-cancer Immunotherapy After Chemotherapy in Adult Patients With Acute Myeloid Leukemia AML
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic as Post-consolidation Therapy in Adult Patients With Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2017-06
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 study is being done to evaluate the safety of a WT1 Antigen-Specific Cancer Immunotherapeutic WT1 ASCI as post-consolidation therapy in adult patients with WT1-positive Acute Myeloid Leukemia in first complete remission It will also be analyzed to what extent this treatment induces an immune response specific to the malignancy
Detailed Description:
In this study patients were to receive a maximum of 24 doses of WT1 ASCI according four cycles over a period of four years
This protocol summary has been updated according to the Protocol Amendment 6 dated 10 Sept 2014
There will no longer be an active follow-up of patients after discontinuation or completion of the treatment The study will end 30 days after the last dose will be administered so the patients will not be further exposed to unnecessary study related procedures In addition no more biological samples will be collected for protocol research purposes For each biological sample already collected in the scope of this study and not tested yet testing will not be performed by default except if a scientific rationale remains relevant Blood sampling for safety monitoring as per protocol will continue
This protocol summary has been updated according to the Protocol Amendment 6 dated 10 Sept 2014
There will no longer be an active follow-up of patients after discontinuation or completion of the treatment The study will end 30 days after the last dose will be administered so the patients will not be further exposed to unnecessary study related procedures In addition no more biological samples will be collected for protocol research purposes For each biological sample already collected in the scope of this study and not tested yet testing will not be performed by default except if a scientific rationale remains relevant Blood sampling for safety monitoring as per protocol will continue
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 |
|---|---|---|---|
| 2010-023886-24 | EUDRACT_NUMBER | None | None |