Ignite Creation Date:
2024-05-05 @ 11:26 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01334060
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2011-04-11
Brief Title:
WT1 Immunity Via DNA Fusion Gene Vaccination in Haematological Malignancies by Intramuscular Injection Followed by Intramuscular Electroporation
Sponsor:
University Hospital Southampton NHS Foundation Trust
Organization:
University Hospital Southampton NHS Foundation Trust
Study Overview
Official Title:
WT1 Immunity Via DNA Fusion Gene Vaccination in Haematological Malignancies by Intramuscular Injection Followed by Intramuscular Electroporation
Status:
COMPLETED
Status Verified Date:
2018-09
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:
WIN
Brief Summary:
The study is not currently recruiting new subjects due to an interruption in funding from its sponsors Efforts are under way to re-establish funding however the study is currently on-hold pending the outcome of these re-funding efforts There have been no safety concerns identified during the study
This is an open label single dose level phase II study in two patient groups CML and AML using genetic randomisation Consented and eligible HLA A2ve patients will be vaccinated with two DNA vaccines and HLA A2 -ve patients will be followed up with molecular monitoring only The objectives are to evaluate 1 Molecular response following pDOM-epitope DNA vaccination in patients with CML BCR-ABL WT1 and AML WT1 at weeks 4 8 12 16 20 and at months 6 12 18 and 24 2 Time to disease progression 2 year survival rate patients with AML 3 Correlation of molecular responses with immunological responses Primary Objective CML Molecular response of BCR-ABL AML Time to disease progression Secondary Objective Molecular response of WT1 transcript levels immune responses to WT1 and DOM Toxicity CML-Time to disease progression next treatment and survival AML-2 year survival overall survival
This is an open label single dose level phase II study in two patient groups CML and AML using genetic randomisation Consented and eligible HLA A2ve patients will be vaccinated with two DNA vaccines and HLA A2 -ve patients will be followed up with molecular monitoring only The objectives are to evaluate 1 Molecular response following pDOM-epitope DNA vaccination in patients with CML BCR-ABL WT1 and AML WT1 at weeks 4 8 12 16 20 and at months 6 12 18 and 24 2 Time to disease progression 2 year survival rate patients with AML 3 Correlation of molecular responses with immunological responses Primary Objective CML Molecular response of BCR-ABL AML Time to disease progression Secondary Objective Molecular response of WT1 transcript levels immune responses to WT1 and DOM Toxicity CML-Time to disease progression next treatment and survival AML-2 year survival overall survival
Detailed Description:
None
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 |
|---|---|---|---|
| ISRCTN62678383 | REGISTRY | NCRN | None |
| 2009-017340-14 | EUDRACT_NUMBER | None | None |