Ignite Creation Date:
2024-05-05 @ 10:13 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01051063
Status:
COMPLETED
Last Update Posted:
2018-11-29
First Post:
2009-12-08
Brief Title:
Evaluation of a New Anti-cancer Immunotherapy in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy
Status:
COMPLETED
Status Verified Date:
2018-06
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:
The purpose of this study is to evaluate the clinical activity and safety of a WT1 Antigen-Specific Cancer Immunotherapeutic WT1 ASCI as post-induction therapy in adult patients with WT1-positive AML presenting a suboptimal clinical response to induction chemotherapy The study will also assess whether this treatment induces a specific immune response to the malignancy
Detailed Description:
At least 40 patients will be enrolled in this study divided in two cohorts of 20 patients each One cohort will include patients in partial remission after induction therapy and one cohort will include patients in complete remission but with incomplete blood count recovery Patients in both cohorts will receive the same study treatment according to the same administration schedule
This protocol summary has been updated according to the Protocol Amendment 3 dated 10 Sept 2014
All active follow-up visits and procedures after the concluding visit 30 days after the last treatment administration will be stopped 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 relevantBlood sampling for safety monitoring as per protocol will continue
This protocol summary has been updated according to the Protocol Amendment 3 dated 10 Sept 2014
All active follow-up visits and procedures after the concluding visit 30 days after the last treatment administration will be stopped 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 relevantBlood 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 |
|---|---|---|---|
| 2008-005348-17 | EUDRACT_NUMBER | None | None |